Conscious Sedation Methodology
Conscious Sedation Methodology
Conscious Sedation Methodology
June 2017
Contents
1 Overview of the SDCEP Guidance Development Process ......................................................................................... 3
12 Acknowledgements................................................................................................................................................................ 13
Guideline G5: Australian and New Zealand College of Anaesthetists (ANZCA), 2014 ................................ 77
Guideline G6: Standing Committee on Sedation for Dentistry (SCSD), 2007 ................................................. 82
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SDCEP Conscious Sedation in Dentistry Guidance Development Methodology
Guideline G14: Intercollegiate Advisory Committee for Sedation in Dentistry (IACSD), 2015 .............. 105
Guideline G15: National Institute for Health and Care Excellence (NICE), 2010 ......................................... 111
Guideline G16: Standing Dental Advisory Committee (SDAC), 2003 .............................................................. 118
Guideline G17: European Association of Paediatric Dentistry (EAPD), 2003 ................................................ 122
Conscious Sedation for Adults and Children with Special Care Needs (Clinical Questions 5.1-5.3) .. 193
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SDCEP Conscious Sedation in Dentistry Guidance Development Methodology
SDCEP first published Conscious Sedation in Dentistry in 2006 and a second edition of the
guidance in 2012. In 2016, a Guidance Development Group (GDG) was convened to review and
update the guidance in light of certain specific developments since 2012. These include
publication of: Safe Sedation Practice for Healthcare Procedures by the Academy of Medical
Royal Colleges (AoMRC) (2013) and Standards for Conscious Sedation in the Provision of Dental
Care: Report of the Intercollegiate Advisory Committee for Sedation in Dentistry (IACSD) (2015),
and an evidence update for the National Institute for Health and Clinical Excellence (NICE)
Guideline: Sedation in Children and Young People (2012).1-3
In accordance with SDCEP’s guidance development process, the review of this guidance
involved also searching for other sources of information and evidence including guidelines and
systematic reviews, and appraisal of all eligible sources to assess their quality and to inform their
utility as the basis for recommendations within this guidance.
The guidance development process that SDCEP follows has been accredited by NICE (National
Institute for Health and Care Excellence; www.nice.org.uk/about/what-we-do/accreditation) and
is as described in the SDCEP Guidance Development Process Manual (Version 1.3, February
2016). The review of Conscious Sedation in Dentistry followed SDCEP’s standard guidance
development process as outlined below, with the exception of the first step (topic proposal and
selection) which is not relevant for an update:
For further details of the standard process see the SDCEP Guidance Development Process
Manual available at www.sdcep.org.uk/how-we-work/sdcep-guidance-development-process/.
Consistent with SDCEP’s standard guidance development methodology the update of Conscious
Sedation in Dentistry aimed to be transparent, systematic and to adhere as far as possible to
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SDCEP Conscious Sedation in Dentistry Guidance Development Methodology
international standards set out by the AGREE (Appraisal of Guidelines Research and Evaluation)
Collaboration (www.agreetrust.org).
Specific details of the methodology used for the update of the Conscious Sedation in Dentistry
guidance are presented either in the full guidance (www.sdcep.org.uk/published-
guidance/sedation/) or in the following sections of this methodology document.
For further details, queries or requests for unpublished information, please contact SDCEP using
the details provided on the front page of this document.
The following Guidance Development Group (GDG), comprising individuals from a range of
branches of the dental and medical professions, with expertise and experience in dental
sedation, along with patient representatives, was convened to update the guidance.
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SDCEP Conscious Sedation in Dentistry Guidance Development Methodology
Scheduled meetings of the GDG took place as part of the guidance development process. The
minutes of these meetings are available from SDCEP on request.
3 Scoping Research
Research to inform the scope and content of the updated guidance was carried out by SDCEP
and their research collaborators TRiaDS (Translation Research in a Dental Setting;
www.triads.org.uk), following the TRiaDS framework for translating guidance recommendations
into practice.4
SDCEP carried out initial scoping work to gain an overview of the current provision of dental
sedation and of sedation training across the UK, and to identify and understand possible issues
arising in response to the Standards for Conscious Sedation in the Provision of Dental Care (2015)
Report of the Intercollegiate Advisory Committee for Sedation in Dentistry (IACSD).2 This
involved semi-structured telephone interviews with more than 20 individuals across the UK
involved in the provision of sedation or sedation training within the hospital, public/community
dental service or general dental practice, or in other roles. Interviewees were invited to
comment on the SDCEP Conscious Sedation in Dentistry (2012) guidance, on the IACSD Report
and on the provision of dental sedation in general.
The IACSD shared with SDCEP much of the feedback it had received about the Report, along
with the responses the IACSD provided to individuals. This and the responses provided as
Frequently Asked Questions (FAQs) on the Royal College of Surgeons England Faculty of Dental
Surgery website were also examined as part of the scoping. The report on the findings can be
found in Appendix 1. A number of the points initially raised in the scoping report were
subsequently addressed through further discussions with the IACSD, new IACSD FAQ answers
and other developments. These are described in the update to the scoping report found in
Appendix 1.
Patient experiences and views on dental sedation were obtained through telephone interviews
conducted by TRiaDS with patients, parents and carers. A report on this is available along with
further information on the TRiaDS website.
4 Clinical Questions
Clinical questions relevant to the scope of the guidance were drafted by the SDCEP Programme
Development Team (PDT) based around the recommendations made in sections 2-9 of the
SDCEP Conscious Sedation in Dentistry guidance 2nd Edition (2012). These formed the basis for
the evidence summaries and considered judgements made by the GDG.
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SDCEP Conscious Sedation in Dentistry Guidance Development Methodology
5 Conscious Sedation for Adults and Children with Special Care Needs
For patients with special care needs that affect provision of their dental care and who are
undergoing dental treatment under sedation:
5.1 which is the preferred (i.e. effective and safe) method of sedation (including drug)?
5.2 what alternative forms of sedation are acceptable and in what circumstances (e.g.
indications, settings)?
5.3 what form of monitoring is required for each sedation technique to reduce the risk
of and identify complications?
6
SDCEP Conscious Sedation in Dentistry Guidance Development Methodology
5 Literature Search
The guiding principle for developing guidance within SDCEP is to first source existing
guidelines, policy documents, legislation or other recommendations. Similarly, relevant
systematic reviews are also identified. These documents are appraised for their quality of
development, evidence base and applicability to the remit of the guidance under development.
In the absence of these documents or when supplementary information is required, other
published literature and unpublished work may be sought.
For this guidance, a comprehensive search of MEDLINE, EMBASE, CINAHL, the Cochrane
Database of Systematic Reviews and the Cochrane Database of Abstracts of Reviews of Effects
(DARE) was carried out on 12 April 2016 and of the National Guidelines Clearinghouse on 13
April 2016. No date limits were applied. Each database was queried with a combination of
sedation and dental terms and 1252 records were retrieved in total. These literature searches
were performed by the Trials Search Co-ordinator, Cochrane Oral Health Group. The details of
the searches can be found in Appendix 2.
Potentially eligible articles were identified from the list of titles and abstracts retrieved. This
article selection was carried out independently in duplicate by researchers within SDCEP and the
Cochrane Oral Health Group. An article was considered eligible if it met all of the following
criteria:
1. The article was a systematic review or a guideline. For this purpose, an article would be
included as a systematic review, if it included a methods section, a search of one or more
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SDCEP Conscious Sedation in Dentistry Guidance Development Methodology
electronic databases and a table of included studies. An article was included as a guideline if
it made recommendations for clinical practice.
2. The article referred to sedation for the provision of dental care that is consistent with the
agreed definition of conscious sedation (stated in Section 1.3 of SDCEP’s Conscious Sedation
in Dentistry (2012)).
The search results were also screened for any articles relevant to sedation training or patient
views and preferences on dental sedation.
Full copies of all potentially eligible articles were retrieved and further checked against the
criteria. Additional manual searching of other resources including NHS Evidence and BioMed
Central for dental AND sedation, searching of specialist society websites and follow up of
citations from relevant articles found through the systematic searching was also carried out.
Other sources of evidence were identified by GDG members. A summary of the 13 guidelines
and 7 systematic reviews appraised for this guidance can be found in Appendix 3.
Eligible articles relevant for each of the clinical questions were identified. Precedence was given
to the most recent articles, where of suitable quality, published in English. A reviewer assessed
the full text of each article and extracted the information applicable to the clinical question. The
evidence appraisal form for each of the relevant articles can be found in Appendix 4.
For the development of this guidance SDCEP used the GRADE (Grading of Recommendations,
Assessment, Development and Evaluation) approach to assess and rate the quality of evidence
presented in the systematic reviews (www.gradeworkinggroup.org). The GRADE framework is a
widely accepted system for grading both the evidence and the recommendations, and is used
internationally by other guideline producers.
After systematic consideration of a number of criteria, including the study types and potential
risk of bias, a GRADE ‘quality of evidence’ rating was assigned to the evidence relevant to a
clinical question. GRADE evidence ratings are defined by the GRADE working group as:
High quality We are very confident that the true effect lies close to that of the estimate of
the effect.
Moderate quality We are moderately confident in the effect estimate: The true effect is likely to
be close to the estimate of the effect, but there is a possibility that it is
substantially different.
Low quality Our confidence in the effect estimate is limited: The true effect may be
substantially different from the estimate of the effect.
Very low quality We have very little confidence in the effect estimate: The true effect is likely
to be substantially different from the estimate of effect.
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SDCEP Conscious Sedation in Dentistry Guidance Development Methodology
The GRADE evidence ratings for the outcomes from each of the systematic reviews are recorded
in the summary table in Appendix 3 and in the respective evidence appraisal forms (Appendix
4).
For guidelines, the AGREE II instrument was used to assess the methodological quality of the
retrieved articles (www.agreetrust.org). The AGREE II instrument is a simple and validated
assessment tool that provides an overall quality score for each guideline and an indication of
how reliable the guideline might be. Since relevant systematic reviews were lacking for many of
the clinical questions, recommendations within the updated SDCEP guidance were informed to
a greater extent by the guidelines. Consequently, for quality assurance, the guideline AGREE
assessments were carried out independently in duplicate by reviewers from SDCEP and the
Cochrane Oral Health Group. Where the scores for a given criterion differed by 2 or more, a
third reviewer reconsidered the criterion and a moderated score was agreed and assigned. The
overall moderated scores are recorded in the evidence appraisal forms in Appendix 4, For clarity,
methodological ratings for guidelines are also shown as one of four levels based on the AGREE
scores (Very low: 1; Low:2/3; Moderate:4/5; High: 6/7). These methodological ratings are
included in the summary table in Appendix 3. The appraisal forms produced by the AGREE II
tool used for assessing guidelines are available on request.
The synthesised evidence from guidelines and systematic reviews for each clinical question was
summarised (Appendix 5) and distributed to members of the GDG prior to meetings of the
group to inform and facilitate the development of the recommendations in the guidance. The
process for development of recommendations was informed by the GRADE approach, in that
considered judgements were made for each clinical question based on the quality of evidence,
the balance of risks and benefits, the values and preferences of patients, and the practicalities of
the treatment or care. The impact of potential barriers to implementation of the
recommendations, which were identified during guidance development and through
stakeholder involvement and external consultation, was also considered.
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SDCEP Conscious Sedation in Dentistry Guidance Development Methodology
The evidence summaries, GDG consideration of the criteria and the resulting outcomes for each
recommendation are recorded in the Considered Judgement Forms (one for each clinical
question) which can be found in Appendix 5. Some of the recommendations were subject to
further review and revisions by the group during the course of the guidance development
process.
For the clinical questions underpinning this particular guidance, much of the evidence identified
comprised other guidelines, most of which were themselves derived from expert opinion.
Consequently, key recommendations informed by these guidelines were designated as based
on expert opinion and since this is not recognised as a category of quality of evidence by
GRADE, were not assigned a strength. Nonetheless, they are considered to be standard
professional practice important for the provision of safe and effective care. Brief explanations of
the basis for each recommendation are included in the guidance text.
A wide range of individuals and organisations with an interest in this topic were given advance
notice of open consultation on the draft guidance. The four-week open consultation period was
initiated in January 2017 and notification of this was sent to a wide range of individuals and
organisations across the UK with a particular interest in this topic, in addition to professional
bodies and charities representing patient groups. During this period the consultation draft was
available on the SDCEP website for comment with a consultation feedback form provided to
facilitate the process. Implementation interviews with potential end-users of the guidance also
took place at this time.
All comments received through the consultation and peer review process were reviewed, the
feedback was considered by the GDG, and the guidance was amended accordingly prior to
publication. The compiled feedback comments and GDG responses are available on request.
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SDCEP Conscious Sedation in Dentistry Guidance Development Methodology
9 Updating guidance
A review of the context of this guidance (e.g. regulations, legislation, trends in working practices,
evidence) will take place three years after publication and, if this has changed significantly, the
guidance will be updated accordingly.
10 Conflicts of Interest
All contributors to SDCEP, including members of the GDG and external expert peer reviewers,
are required to complete an SDCEP Declaration of Interests form to disclose relevant interests
including financial conflicts of interest, such as receipt of fees for consulting with industry, and
intellectual conflicts of interest, such as publication of original data bearing directly on a
recommendation. These forms are held by SDCEP, updated yearly and are available on request.
At the beginning of each group meeting during guidance development, participants are asked
to confirm whether there are any changes to their Declaration of Interests.
Declared interests which could have potentially constituted a conflict of interest were
considered by the SDCEP PDT, the GDG chair and the group to decide whether and how the
extent of the individual’s participation in the guidance development should be limited (e.g.
exclusion from certain decisions or stages, or complete withdrawal).
The Declarations of Interest forms for all individuals involved in the Conscious Sedation in
Dentistry guidance update project are available on request. A summary of the declarations and
the consideration of potential conflicts of interest and management decisions are provided in
the following table.
Summary of Disclosures
All of the GDG members, peer reviewers and members of the SDCEP PDT completed and returned the
Declaration of Interests form. The Clinical Chair of the GDG had no declared interests.
Professional roles in sedation provision, teaching or inspection through employment within non-
commercial organisations were not considered to be a conflict of interests. A number of group
members declared membership of committees or societies relevant to dental sedation, but this was
also considered unlikely to lead to a conflict of interest.
Four of the fifteen external GDG members disclosed direct financial interests relevant to the guidance
topic which could potentially cause, or be perceived to cause, conflicts of interest.
None of the SDCEP PDT members had any interests relevant to the guidance.
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SDCEP Conscious Sedation in Dentistry Guidance Development Methodology
Francis Collier 1. Occasional fee paid sedation provision for other dental practices
Giju George 2. Private clinical work at Spire Liverpool Hospital and at Mellow Dental
3. Private sedation training for doctors, nurses and dentists (Mellow Dental)
The potential for any work carried out by SDCEP, within the Clinical Effectiveness workstream of
NHS Education for Scotland (NES), to discriminate against or disadvantage any group of
individuals has been considered through an Equality Impact Assessment (EQIA) published on
the NES website (http://www.nes.scot.nhs.uk/about-us/equality-and-diversity/equality-impact-
assessments.aspx).
The possibility of inequalities associated specifically with the Conscious Sedation in Dentistry
guidance was considered at various stages during guidance development, in accordance with
the EQIA. Potential issues were identified through discussions with guidance development
group members, from interviews with practitioners and patients and from feedback from the
external consultation.
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SDCEP Conscious Sedation in Dentistry Guidance Development Methodology
Briefly, the issues identified mostly related to the potential for the guidance recommendations
to disadvantage certain patient groups by affecting aspects of sedation service delivery.
Examples include:
While the groups identified are not those specifically described by the legally protected
characteristics defined in the Equality Act 2010, the issues were given full consideration by the
GDG. The GDG agreed on the importance of balancing the need for equitable treatment with
the need for patient safety, noting that in some cases the need to ensure patient safety and care
would override potential discrimination in terms of access to treatment. Several of the
recommendations made in the consulation draft of the guidance were reconsidered and revised
to address the potential equality issues described.
Further details of the issues identified and specific actions taken or planned are recorded in an
EQIA checklist which is available on request.
12 Acknowledgements
SDCEP would like to acknowledge Anne Littlewood, Anne-Marie Glenny, Tanya Walsh and Helen
Worthington of the Cochrane Oral Health Group for performing literature searches and
contributing to evidence selection and appraisals, and Colin Halliday, Jose Marshall and Karen
Gordon, NHS Lothian, for advice on the learning outcomes listed in Appendix 2. SDCEP also
wish to acknowledge representatives of the Intercollegiate Advisory Committee for Sedation in
Dentistry (IACSD), David Craig, Richard Ibbetson, Kate Rivett and Anna-Maria Rollin for their
feedback and other personal communications during the guidance development process.
SDCEP is grateful to individuals who participated in interviews during scoping and consultation,
to all those who provided feedback through consultation and to peer reviewers.
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Appendix 1 – Scoping Report May 2016
Note that since the production of this scoping report a number of the points raised within it
have been addressed through further discussions, new IACSD FAQ answers and other
developments. These are summarised in an update at the end of the report.
Semi-structured interviews with more than 20 individuals across the UK involved in the
provision of sedation or sedation training within the hospital, public/community dental
service or general dental practice, or in other roles, were carried out. Interviewees were
invited to comment on the SDCEP Conscious Sedation in Dentistry (2012) guidance, on the
IACSD Report and on the provision of dental sedation in general.
The IACSD shared with SDCEP some of the feedback received about the Report, along with
the responses IACSD provided to individuals. This and the responses provided as FAQs on
the Royal College of Surgeons England website were also examined as part of the scoping.
The findings are as follows. Please note that these are based on the opinions of individuals
and may not reflect the views of all sedation providers and trainers.
General points:
SDCEP guidance:
For those familiar with this document, SDCEP’s 2012 guidance was acknowledged as being
clear, easy to use and well laid out. The inclusion of the basis for recommendations was
valued by users (though some noted that the main recommendations were mandatory or
based on expert opinion rather than evidence-based). Several of the interviewees suggested
that the scope of the updated guidance should be widened to be more in line with the areas
of sedation included in the IACSD Report e.g. to include more on alternative anxiety
management strategies and advanced sedation techniques and to provide an increased
range of patient information. Further suggestions made were to include more detailed
information about life support, training, audit, consent and ASA levels.
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Appendix 1 – Scoping Report May 2016
Regarding the IACSD Report, while some of the opinions and concerns differed across the
dental service and between countries, there were also common themes identified. Many of
the individuals interviewed were supportive of the Report and its aspirations for dental
sedation. Particular areas that were acknowledged as improvements included the
recommendations around more consistent validated training, those for ongoing CPD and for
audit. A number of individuals were aware of the challenges in developing standards that are
acceptable from both dental and medical perspectives.
General issues raised included uncertainty around some aspects of the Report, which has led
to confusion about how to comply with the standards. This is causing difficulties in
commissioning of sedation services. It was reported that the FAQs developed by the IACSD
have gone some way towards addressing this, but that further elucidation would be
beneficial for some aspects. A number of individuals advised that an indication of the basis
(whether evidence-based, expert opinion, regulatory etc) for each of the standards set would
aid acceptance and implementation of the IACSD Report.
Some individuals were concerned about the perceived lack of consideration given to
possible barriers to implementation of the standards across the UK and the potential impact
on sedation provision. That the standards were introduced with immediate effect from
publication without time to make provision for complying with them, for example before the
provision of approved training could be established, has exacerbated these concerns.
Specific points:
Several specific points relating to the IACSD Report were commonly identified. To a great
extent these reflect the queries already communicated directly to the IACSD committee and
which were contained in the feedback provided to SDCEP. These are outlined as follows:
15
Appendix 1 – Scoping Report May 2016
who the IACSD consider to be suitable providers of this, would help implementation.
Without this there is likely to be inconsistency across the country in levels of life support
skills. This could cause issues around defensibility and potential negligence.
• Some have queried the necessity for ILS/PILS training for dental nurses who are assisting
with only inhalation sedation, taking into consideration the practicalities (e.g. cost
implications and lack of accessibility) of obtaining this training. It would be helpful if the
IACSD could confirm the elements of life support training that are suited to these staff as
part of life support training adapted for dental sedation.
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Appendix 1 – Scoping Report May 2016
staffing issues in both the short and longer term and particularly within the general
dental service.
CPD
• While the clear statement on the requirement for 12 hours of verifiable CPD per 5 years is
considered helpful, some individuals expressed concern about the current lack of
availability of verifiable CPD opportunities for sedation.
• The IACSD FAQs and responses to individual queries clarify that although CPD should be
verifiable, CPD and update courses do not need to be externally accredited.
Fasting
• The recommendation around fasting provided in the standards is considered by some to
be open to varying interpretation. Those who interpret the standard as a requirement for
fasting for conscious sedation queried the basis for this.
Monitoring
• A need for further clarity around intra-operative blood pressure monitoring has been
raised by some as an issue.
• The IACSD FAQs reiterate that “NIBP should be performed before and after sedation and at
‘appropriate intervals’ during the procedure” with intervals “determined following
individual patient assessment”.
• Some individuals have questioned the value of intra-operative BP monitoring in addition
to clinical monitoring, for ASA I&II patients.
• Others would like further information on what is meant by ‘appropriate intervals’ and at
what level the BP should be of concern. Scenario based examples may be helpful.
17
Appendix 1 – Scoping Report May 2016
the criteria could be met instead by establishing links with a suitable qualified individual
through a clinical network. An FAQ that explains this would be helpful.
• Individuals have reported withdrawing the provision of advanced sedation in response to
the standards, particularly because of an inability to meet these requirements as they
have understood them (e.g. skills equivalent to those expected of a specialist/consultant
in paediatric dentistry). Significant concerns have been expressed about the consequent
impact on hospital services due to referrals, particularly in England. A further predicted
impact is a greater number of children receiving general anaesthesia, if advanced
sedation services are not developed in hospital services.
Maintaining competency
• Some individuals reported that the standards are very prescriptive about training
requirements for staff new to sedation but unclear about requirements for maintaining
competency for existing sedation providers i.e. how many cases of sedation should be
carried out a year to remain competent.
• The IACSD FAQs suggest that an indemnity organisation should be consulted, rather than
stating a number of cases.
• The IACSD responses to individual queries advise that the number of cases required to
achieve competence might be a useful guide. The timescale for this is unclear.
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Appendix 1 – Scoping Report May 2016
At the time of this update, the IACSD had confirmed that more than 30 sedation training
courses had been accredited. IACSD confirmed that ‘in-house’ training programmes can
apply for accreditation. The IACSD also indicated that it intends to make public a list of
accredited sedation training providers.
The IACSD has also launched a scheme to approve clinical supervisors for new trainees
(https://www.rcseng.ac.uk/dental-faculties/fds/publications-guidelines/standards-for-
conscious-sedation-in-the-provision-of-dental-care-and-accreditation/application-for-
supervisor-approval/).
A new FAQ explaining the requirements for ‘skills equivalent to those expected of a consultant
in anaesthesia competent in sedation for dentistry’ for anaesthetists and medical and dental
sedationists was also made available by the IACSD. Arrangements for assessing compliance
with the requirements may be developed by the Royal Colleges.
Regarding the terms ‘a facility equivalent to an NHS Acute Trust in England’ and ‘equivalent
range of skills and facilities to be found in an NHS Acute Trust’, the most recent FAQ indicated
that this could include written protocols for managing collapse and adverse reactions, the
timely transfer of a collapsed patient to a hospital with appropriate resuscitation facilities, the
regular checking of emergency drugs and equipment, current immediate life support training
and regular team-based participation in real-time emergency scenarios. Further
communications clarified the intention that all of the elements described in the FAQ should
be in place for dealing with an emergency for any patient, irrespective of the sedation
technique.
Maintaining competency
Further discussion with IACSD around how sedation team members can demonstrate that
they are suitably experienced clarified the difficulties in specifying a number of cases over a
particular time period that would be appropriate for all healthcare professionals. An
individual’s level of experience will also be dependent on their accumulated experience,
previous frequency of cases and the types of cases (e.g. technique, patient group,
complexity) they were involved in.
19
Appendix 2 – Evidence Searches Guidance Development Methods
20
Appendix 2 – Evidence Searches Guidance Development Methods
21
Appendix 2 – Evidence Searches Guidance Development Methods
1. exp Dentistry/
2. exp Oral surgical procedures/
3. (dental or dentist$).mp.
4. ((oral or periodont$) adj5 surg$).mp.
5. (pulpotom$ or pulpect$ or endodont$ or "pulp cap$" or apicoectom$ or apicectom$
or gingivectom$ or gingivoplast$).mp.
6. ((dental or teeth or tooth or molar$) adj5 (fill$ or restor$ or extract$ or remov$ or
"cavity prep$" or caries or carious or decay$ or scal$ or polish$ or "root plan$" or
scrap$ or "oral prophylaxis")).mp.
7. ("root canal" and (therap$ or treat$)).mp.
8. (tooth adj3 replant$).mp.
9. ((dental or oral) adj2 (implant$ or prosthetic$)).mp.
10. "root surface instrumentation".mp.
11. ((oral or mouth or dental) adj5 biops$).mp.
12. (crown$ or bridge$ or prosthodontic$).mp.
13. Dental anxiety/
14. ((dental or dentist) and (fear$ or anxiet$ or phobia$)).mp.
15. ((special$ adj3 (care or need$)) and (dentist$ or dental)).mp.
16. or/1-15
17. Conscious sedation/
18. exp "Hypnotics and sedatives"/
19. exp Anti-anxiety agents/
20. Ketamine/
21. (ketamine or ketaject or ketalar or ketamina or ketaminum or ketanest or Calipsol or
Calypsol or Kalipsol or ketaset).ti,ab.
22. Propofol/
23. (propofol or anepol or anespro or anesvan or critifol or diprivan or disoprivan or
disoprofol or dormofol or fresofol or gobbifol or hipnolam or hypro or "iv pro" or
lipuro or "oleo lax" or plofed or profol or profolen or propofabb or propofil or
propofolum or propogen or propolipid or propovan or propoven or provive or
rapinovet or recofol or safol or trivam or troypofol or unifol or Aquafol or Ivofol).ti,ab.
24. Midazolam/
25. (anquil or benzosed or buccolam or dalam or damizol or demizolam or doricum or
dormicum or dormid or dormipron or dormire or dormitol or dormixal or dormonid
or drimnorth or epistatus or flormidal or fulsed or "fulsed injection" or garen or
gobbizolam or hipnazolam or hipnoz or hypnofast or hypnovel or ipnovel or
midazolam or midazolamum or nocturna or setam or talentum or terap or
versed).ti,ab.
26. Diazepam/
27. (diapam or diastat or diazemuls or diazepam or "methyl diazepinone" or nervium or
relanium or valium or Apaurin or Faustan or Relanium or Seduxen or Sibazon or
Stesolid).ti,ab.
28. Fentanyl/
22
Appendix 2 – Evidence Searches Guidance Development Methods
Linked to the SIGN filter for identifying systematic reviews in MEDLINE Ovid, source:
http://www.sign.ac.uk/methodology/filters.html#systematic
1. Meta-Analysis as Topic/
2. meta analy$.tw.
3. metaanaly$.tw.
4. Meta-Analysis/
5. (systematic adj (review$1 or overview$1)).tw.
6. exp Review Literature as Topic/
7. or/1-6
8. cochrane.ab.
9. embase.ab.
10. (psychlit or psyclit).ab.
11. (psychinfo or psycinfo).ab.
12. (cinahl or cinhal).ab.
13. science citation index.ab.
14. bids.ab.
15. cancerlit.ab.
16. or/8-15
17. reference list$.ab.
18. bibliograph$.ab.
19. hand-search$.ab.
20. relevant journals.ab.
21. manual search$.ab.
22. or/17-21
23. selection criteria.ab.
23
Appendix 2 – Evidence Searches Guidance Development Methods
Linked to an adapted version of the CADTH filter for identifying guidelines in MEDLINE Ovid,
source: https://www.cadth.ca/resources/finding-evidence/strings-attached-cadths-database-
search-filters#guide
24
Appendix 2 – Evidence Searches Guidance Development Methods
1. exp Dentistry/
2. exp Oral surgery/
3. (dental or dentist$).mp.
4. ((oral or periodont$) adj5 surg$).mp.
5. (pulpotom$ or pulpect$ or endodont$ or "pulp cap$" or apicoectom$ or apicectom$
or gingivectom$ or gingivoplast$).mp.
6. ((dental or teeth or tooth or molar$) adj5 (fill$ or restor$ or extract$ or remov$ or
"cavity prep$" or caries or carious or decay$ or scal$ or polish$ or "root plan$" or
scrap$ or "oral prophylaxis")).mp.
7. ("root canal" and (therap$ or treat$)).mp.
8. (tooth adj3 replant$).mp.
9. ((dental or oral) adj2 (implant$ or prosthetic$)).mp.
10. "root surface instrumentation".mp.
11. ((oral or mouth or dental) adj5 biops$).mp.
12. (crown$ or bridge$ or prosthodontic$).mp.
13. Dental anxiety/
14. ((dental or dentist) and (fear$ or anxiet$ or phobia$)).mp.
15. ((special$ adj3 (care or need$)) and (dentist$ or dental)).mp.
16. or/1-15
17. Conscious sedation/
18. exp "hypnotic sedative agent"/
19. exp Anti-anxiety agents/
20. Ketamine/
21. (ketamine or ketaject or ketalar or ketamina or ketaminum or ketanest or Calipsol or
Calypsol or Kalipsol or ketaset).ti,ab.
22. Propofol/
23. (propofol or anepol or anespro or anesvan or critifol or diprivan or disoprivan or
disoprofol or dormofol or fresofol or gobbifol or hipnolam or hypro or "iv pro" or
lipuro or "oleo lax" or plofed or profol or profolen or propofabb or propofil or
propofolum or propogen or propolipid or propovan or propoven or provive or
rapinovet or recofol or safol or trivam or troypofol or unifol or Aquafol or Ivofol).ti,ab.
24. Midazolam/
25. (anquil or benzosed or buccolam or dalam or damizol or demizolam or doricum or
dormicum or dormid or dormipron or dormire or dormitol or dormixal or dormonid
or drimnorth or epistatus or flormidal or fulsed or "fulsed injection" or garen or
gobbizolam or hipnazolam or hipnoz or hypnofast or hypnovel or ipnovel or
midazolam or midazolamum or nocturna or setam or talentum or terap or
versed).ti,ab.
26. Diazepam/
27. (diapam or diastat or diazemuls or diazepam or "methyl diazepinone" or nervium or
relanium or valium or Apaurin or Faustan or Relanium or Seduxen or Sibazon or
25
Appendix 2 – Evidence Searches Guidance Development Methods
Stesolid).ti,ab.
28. Fentanyl/
29. (abstral or actiq or duragesic or durogesic or fentanest or fentanil or fentanila or
fentanilo or fentanyl or fentanyl or fentanylum or lazanda or nasalfent or phentanyl
or rapinyl or subsys or fentora or sublimaze).ti,ab.
30. Nitrous oxide/
31. ("nitrous oxide" or "laughing gas" or "nitrogen protoxide").ti,ab.
32. (sevoflurane or sevorane or Ultane).ti,ab.
33. Temazepam/
34. (euhypnos or norkotral or normison or nortem or remestan or restoril or temaze or
temazepam or temtabs or Dasuen or hydroxydiazepam or Levanxol or
Methyloxazepam or Nocturne or Normitab or oxydiazepam or Planum or Signopam
or Temaze).ti,ab.
35. Benzodiazepine derivative/
36. (benzodiazepine$ or Triazolam or Halcion or Sonata or Zaleplon or Ativan or
Lorazepam or Vistaril or hydroxyzine or Xanax).ti,ab.
37. "narcotic analgesic agent"/
38. (opioid$ and sedat$).ti,ab.
39. Dental anesthesia/
40. (sedat$ or anesthe$ or anaesthe$ or analges$).ti,ab.
41. or/17-40
42. 16 and 41
Linked to the SIGN filter for identifying systematic reviews in Embase Ovid, source:
http://www.sign.ac.uk/methodology/filters.html#systematic
26
Appendix 2 – Evidence Searches Guidance Development Methods
22. 20 or 21
23. review.pt.
24. 22 and 23
25. letter.pt.
26. editorial.pt.
27. animal/
28. human/
29. 27 not (27 and 28)
30. or/25-26,29
31. 4 or 13 or 19 or 24
32. 31 not 30
Linked to an adapted version of the CADTH filter for identifying guidelines in Embase Ovid,
source: https://www.cadth.ca/resources/finding-evidence/strings-attached-cadths-database-
search-filters#guide
27
Appendix 2 – Evidence Searches Guidance Development Methods
28
Appendix 2 – Evidence Searches Guidance Development Methods
13 April 2016
29
Appendix 3 – Summary of Guidelines and Systematic Reviews Guidance Development Methods
a
For clarity, methodological ratings for the guidelines appraised are shown as one of four levels based on the AGREE scores (Very low: 1; Low:2/3;
Moderate:4/5; High: 6/7).
b
Updated in 2016; see Appendix 4 for further details.
30
Appendix 3 – Summary of Guidelines and Systematic Reviews Guidance Development Methods
G8 Guideline on use of nitrous oxide American Academy of Paediatric 2013 • Children - dental
for pediatric dental patients9 Dentistry (AAPD) • Most aspects of N2O
Low
inhalation sedation
USA provision
G10 Guideline for Monitoring and American Academies of Pediatrics 2011a • Children - dental
Management of Pediatric Patients (AAP) and Pediatric Dentistry (AAPD) • Most aspects of sedation
During and After Sedation for provision Low
Diagnostic and Therapeutic
Procedures10 USA
G12 Special Care Dentistry Association Glassman, P., A. Caputo, et al. Special 2009 • Special needs - dental
consensus statement on sedation, Care Dentistry Association • Justifying the decision to
anesthesia, and alternative Special care in dentistry use sedation Low
techniques for people with special
needs.11 USA
G13 UK National Clinical Guidelines in Hosey, M. T. 2002 • Children - dental
Paediatric Dentistry. British Society for Paediatric Dentistry • Most aspects of sedation
Managing anxious children: the (2002). provision Moderate
use of conscious sedation in International journal of paediatric
paediatric dentistry12 dentistry UK
G14 Standards for Conscious Sedation The dental faculties of the royal 2015 • All - dental
in the Provision of Dental Care. colleges and the Royal College of • All aspects of sedation
Report of the Intercollegiate Anaesthetists provision
Low
Advisory Committee for Sedation
in Dentistry (IACSD)2 UK
a
Updated in 2016; see Appendix 4 for further details.
31
Appendix 3 – Summary of Guidelines and Systematic Reviews Guidance Development Methods
G15 Sedation in under 19s: using National Institute for Health and Care 2010 • Children – not dental
sedation for diagnostic and Excellence (NICE) (up- restricted
High
therapeutic procedures3,13 UK dated • All aspects of sedation
2012) provision
G16 Standing Dental Advisory Report of an Expert Group on 2003 • All - dental
Committee Sedation for Dentistry Commissioned • Most aspects of sedation
Low
Conscious Sedation in the by the Department of Health provision
Provision of Dental Care14 UK
G17 EAPD Guidelines on Sedation in A.-L. Hallonsten, B. Jensen, M. Raadal, 2003 • Children – dental
Paediatric Dentistry15 J. Veerkamp, M.T. Hosey, S. Poulsen; • Most aspects of sedation
European Association of Paediatric provision Low
Dentistry
EU
Ref Title Author/Source Year Relevant Patient Group Evidence Quality
No. (GRADE)
Focus
SR1 Sedation versus general Ashley, P.F., CECS Williams, D.R. 2015 • Children – dental
anaesthesia for provision of dental Moles, J. Parry. • Efficacy No qualifying
treatment to patients younger Cochrane Database of Systematic • Adverse events evidence
than 18 years.16 Reviews
SR2 The anxiolytic effect of midazolam Chen, Q., L. Wang, et al. PLoS ONE 2015 • All - dental Efficacy:
in third molar extraction: a • Midazolam efficacy for Moderate
systematic review.17 anxiolysis Adverse events:
• Adverse events Very low
SR5 Sedation of children undergoing Lourenço-Matharu, L., P.F. Ashley, S. 2012 • Children - dental Oral Midazolam:
dental treatment.18 Furness. Cochrane Database of • Efficacy of various drugs Low
Systematic Reviews for behaviour N2O/O2:
management. Very low
SR6 Inhalation sedation with nitrous Lyratzopoulos, G. and K. M. Blain. 2003 • Children – dental Low to
oxide as an alternative to dental Journal of Public Health Medicine • Efficacy of N2O/O2
general anaesthesia for children.19 • Adverse events Very low
32
Appendix 3 – Summary of Guidelines and Systematic Reviews Guidance Development Methods
SR7 Reported side effects of Papineni McIntosh A., P. F. Ashley et 2015 • Children – dental Low to
intravenous midazolam sedation al. International Journal of Paediatric • Intravenous midazolam –
when used in paediatric dentistry: Dentistry adverse events Very low
a review.20
SR8 Safety of oral midazolam sedation Papineni, A., L. Lourenço-Matharu, et 2014 • Children – dental Low to
use in paediatric dentistry: a al. International Journal of Paediatric • Oral midazolam – adverse
Very low
review.21 Dentistry events
SR9 A review of the use of intranasally Davies, D.J.H. Journal of Disability and 2015 • Adults – dental
Efficacy:
administered midazolam in adults Oral Health. • Intranasal midazolam –
Low
and its application in dentistry.22 efficacy
• Adverse events
33
Appendix 4 – Evidence Appraisal Forms Systematic Review SR1: Ashley et al., 2015
Patient/Problem: (target patients Intervention or risk factors: Comparison: Outcomes: note with * those which are critical/important (from patient perspective) for the
and actual participant characteristics) guidance recommendation
Children and adolescents undergoing Sedative agents administered via General Primary outcomes
dental treatment including fillings, any route by an anaesthetist, a anaesthesia • *Mortality (if any).
removal of the nerve from a tooth and dentist or another healthcare administered
• *Completion of treatment: yes or no.
extraction of a tooth. professional in any setting. via any route
by an • *Postoperative morbidity.
anaesthetist, a Secondary outcomes
dentist or • Cost to the participant.
another
• Cost of the procedure.
healthcare
professional in • Participant satisfaction.
any setting. • Parental satisfaction.
• Intraoperative morbidity.
Appropriate study types? RCTs Appropriate search terms? Yes, Inclusion criteria:
Correct components to address provided in appendix Planned to include randomized controlled clinical trials that compared sedative agents versus
general anaesthesia in children and adolescents up to 18 years of age undergoing dental
34
Appendix 4 – Evidence Appraisal Forms Systematic Review SR1: Ashley et al., 2015
Risk of bias/systematic error (study limitations that could cause systematic error): consider risk of bias for each important outcome
Randomisation: is it reported and Blinding: consider whether blinding of patients or Other limitations: e.g. attrition bias (incomplete accounting of patients and outcome events),
appropriate? assessors would be important for outcomes reporting bias (selective outcome reporting), surrogate outcomes(?)
considered
No eligible studies No eligible studies
No eligible studies
Inconsistency: Refers to unexplained Imprecision (random error): Indirectness: consider i) whether Publication bias:
heterogeneity in results. interventions of interest were compared e.g. when intervention is new and not many
directly or not; ii) whether population studies available- may be biased for positive
characteristics or settings differ from those results
of interest
35
Appendix 4 – Evidence Appraisal Forms Systematic Review SR1: Ashley et al., 2015
Adverse events were to be considered as a primary outcome. Cost effectiveness was to be considered Patient satisfaction was to considered as
secondary outcome.
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
36
Appendix 4 – Evidence Appraisal Forms Systematic Review SR2: Chen et al., 2015
Patient/Problem: (target patients Intervention or risk factors: Comparison: Outcomes: note with * those which are critical/important (from patient perspective) for the
and actual participant characteristics) guidance recommendation
Anxious patient undergoing removal midazolam placebo or 1. *Efficacy – measured by assessment of anxiety levels using different methods
of third molar other anti- 2. *Incidence of adverse events
anxiety agents
Appropriate study types? RCTs Appropriate search terms? Yes, but Inclusion criteria:
Correct components to address could have included alternative names for (1) Studies had to include dentally anxious outpatients who had undergone third molar
midazolam extraction, regardless of gender or race;
question? Yes
Appropriate databases? Cochrane (2) published studies, including grey literature, had to be randomized, double-blind, and
Study no.s: 10
Library, CENTRAL, Medline, Embase, refer to midazolam’s effect on dental anxiety compared with that of placebo or other anti-
Study sizes: see overall results below anxiety agents;
Unpublished studies? SIGLE
Follow up of citations? yes (3) studies had to have outcome indices, including the patients’ anxiety levels.
Risk of bias/systematic error (study limitations that could cause systematic error): consider risk of bias for each important outcome
Randomisation: is it reported and Blinding: consider whether blinding of patients or Other limitations: e.g. attrition bias (incomplete accounting of patients and outcome events),
assessors would be important for outcomes
37
Appendix 4 – Evidence Appraisal Forms Systematic Review SR2: Chen et al., 2015
Inconsistency: Refers to unexplained Imprecision (random error): Indirectness: consider i) whether Publication bias:
heterogeneity in results. interventions of interest were compared e.g. when intervention is new and not many
directly or not; ii) whether population studies available- may be biased for positive
characteristics or settings differ from those results
of interest
Is heterogeneity analysis reported? Confidence intervals not reported Midazolam was compared to placebo in No assessment done.
No formal analysis but noted that 1 some studies and to other drugs in other
study comparing midazolam with studies.
placebo had contradictory results (had Different routes of administration were
high risk of bias) included.
Locations and settings of populations in
individual studies not stated.
Was meta analysis conducted? 1. For 5/6 studies comparing midazolam (304 patients) with placebo (338), there was a
No meta-analysis, because of different anxiety scales used to assess efficacy and variation in statistically significant effect on anxiety relief. For 3 of these studies ES (effect size)
treatments and controls calculations were done and all were >0.8 indicating effectiveness.
1 study (55 patients per group) indicated that propofol was more effective than
Are results for individual studies shown? yes
midazolam.
Was it reasonable to combine study results? no 1 study (20 patients per group) indicated that diazepam was more effective than
Was an appropriate method used? n/a midazolam or lorazepam.
Are reasons for variation in results discussed? Yes – in that high risk of bias for 1 2 studies (1192 patients in total) found that multidrug combinations were more effective
than midazolam alone.
38
Appendix 4 – Evidence Appraisal Forms Systematic Review SR2: Chen et al., 2015
contradictory study is discussed 2. Reported that incidence of adverse events was no higher with midazolam than placebo –
Would confounders affect overall resulta? no further information provided.
Some patients in groups taking fentanyl had respiratory depression
Is the effect substantiala?
Is there dose-response dataa?
Adverse events recorded for some studies e.g. drowsiness, Efficacy versus adverse events discussed Not discussed
lack of coordination, disorientation, and decreased saturation
of blood oxygen.
Diazepam caused pain on injection in some cases.
Multidrug combinations including fentanyl led to respiratory
depression in some cases.
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
39
Appendix 4 – Evidence Appraisal Forms Systematic Review SR2: Chen et al., 2015
SDCEP guidance themes: and it is not clear which studies the data is taken
from.
sedation technique ✓, patient selection X, records X, consent X, training X, monitoring (✓), fasting X, environment X, equipment (✓),
staffing X, patient views X (✓)= mentioned but not in detail.
40
Appendix 4 – Evidence Appraisal Forms Systematic Review SR5: Lourenço-Matharu et al., 2012
Patient/Problem: (target patients Intervention or risk factors: Comparison: Outcomes: note with * those which are critical/important (from patient perspective)
and actual participant characteristics) for the guidance recommendation
Age of patients included in the trials Any sedative agent via any route Placebo (including Primary
ranged from 1 year to 16 years. Mean of admission that can be no intervention) or *Behaviour
age (approximation) for all studies was administered by a dentist, alternative sedation Secondary
4.7 years. The mean number of anaesthetist, sedationist or agent
1. *Completion of treatment (yes/no)
participants was 78 (standard dental auxiliary in an outpatient or different dosage
deviation (SD) = 124) with a total of setting or dental office. 2. Postoperative anxiety
of the same agent.
2810 subjects randomised in the 36 Vs placebo: 3. *Adverse events
included trials. Oral midazolam Behaviour was measured by a range of different indices; where possible these were
Nitrous oxide/oxygen combined to allow meta-analysis to be carried out. Behaviour for the procedure
Chloral hydrate overall will be recorded; if this information is not available then behaviour at the time
Meperidine of injection will be used.
Vs different dosage:
Hydroxyzine
Midazolam(intranasal)
Midazolam(oral)
Vs other agents
Chloral
hydrate/hydroxyzine
Chloral
hydrate/promethazine
Ketamine
Midazolam(oral)
Midazolam(rectal)
41
Appendix 4 – Evidence Appraisal Forms Systematic Review SR5: Lourenço-Matharu et al., 2012
Sevoflurane
Risk of bias/systematic error (study limitations that could cause systematic error): consider risk of bias for each important outcome
Randomisation: is it reported and Blinding: consider whether blinding of patients or Other limitations: e.g. attrition bias (incomplete accounting of patients and outcome
appropriate? assessors would be important for outcomes considered events), reporting bias (selective outcome reporting), surrogate outcomes(?)
2/36 studies assessed as low risk of Twenty (56%) trials were assessed as being at low risk In many trials it was not possible to know if drop-out had occurred or not. 23 trials were
bias in sequence generation and of performance and detection biases. In six trials only at risk of attrition bias. Baseline demographics were poorly reported in seven trials.
allocation. Most studies at unclear risk the assessor was blind to the intervention, in three trials Overall: Of the 36 trials included in this review none were assessed as being at low risk
of bias due to failure to report. the operator and the outcome assessor was blinded, of bias overall. Six trials (17%) were assessed as being at unclear risk of bias and in the
and in four trials there was no blinding. remaining 30 trials (83%) at least one domain was assessed as being at high risk of bias.
Inconsistency: Refers to unexplained Imprecision (random error): e.g. confidence Indirectness: consider i) whether Publication bias: e.g. when intervention
heterogeneity in results. intervals presented interventions of interest were compared is new and not many studies available-
directly or not; ii) whether population may be biased for positive results
characteristics or settings differ from those
of interest
42
Appendix 4 – Evidence Appraisal Forms Systematic Review SR5: Lourenço-Matharu et al., 2012
Is heterogeneity analysis reported? CI of SMD reported for Intervention comparisons varied Search was thorough, so likely to have
Heterogeneity in the results of the Oral midazolam vs placebo 2.98 [ 1.58, 4.37 ] considerably between studies making an retrieved relevant publications.
trials was assessed where appropriate overall assessment of effect impossible. No assessment of publication bias
N2O vs placebo 0.69 [ 0.13, 1.26 ]
by inspection of a graphical display of Studies from 13 countries, majority in USA. presented.
the results and by formal tests of Eleven of the included studies reported the
heterogeneity. Only in the case of oral use of Papoose boards or Pediwrap to
midazalam vs placebo was it possible support or restrain children during the
to calculate heterogeneity, which was dental procedure. Treatment settings were
considerable (I² = 91%, P < 0.00001). unclear.
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
43
Appendix 4 – Evidence Appraisal Forms Systematic Review SR5: Lourenço-Matharu et al., 2012
44
Appendix 4 – Evidence Appraisal Forms Systematic Review SR5: Lourenço-Matharu et al., 2012
45
Appendix 4 – Evidence Appraisal Forms Systematic Review SR6: Lyratzopoulos and Blain, 2003
Patient/Problem: (target patients Intervention or risk Comparison: Outcomes: note with * those which are critical/important (from patient perspective) for the
and actual participant characteristics) factors: guidance recommendation
Children judged untreatable without Inhalation sedation with DGA in 2 of the 1. *Effectiveness (acceptance or completion of planned dental treatment under IHS
resort to DGA (dental general nitrous oxide (N2O) and studies, no 2. Factors associated with IHS treatment failure
anaesthetic). local anaesthesia. comparator for other 3. *Morbidity (i.e. side effects)
studies. 4. Mean time required per session
5. Treatment sessions required per patient
6. *User satisfaction
7. Cost
Not all outcomes were reported in all studies.
46
Appendix 4 – Evidence Appraisal Forms Systematic Review SR6: Lyratzopoulos and Blain, 2003
patients in total treated with IHS, 300 Unpublished studies? yes offered IHS
with DGA Exclusion criteria:
Follow up of citations? yes
Personal contact with experts? yes • had no clear inclusion criteria for participating patients;
• reported only effects of IHS on physiological parameters (such as heart rate and oxygen
saturation) or only examined pharmacological safety;
• included mainly other interventions, behavioural or medical, with or without IHS (e.g.
hypnosis, behavioural management, administration of other oral, intravenous or inhaled
agents);
• reported on fewer than 20 cases;
• included mainly adult patients or did not report results for children in subgroups;
• were non-systematic reviews or letters;
• were duplicate publications (wholly, or in part) of studies already included in the review.
Risk of bias/systematic error (study limitations that could cause systematic error): consider risk of bias for each important outcome
Randomisation (selection bias): is it Blinding: consider whether blinding of patients or Other limitations: e.g. attrition bias (incomplete accounting of patients and outcome events),
reported and appropriate (include assessors would be important for outcomes reporting bias (selective outcome reporting), surrogate outcomes(?)
sequence generation and allocation considered
concealment if possible)?
Of the comparator studies one had an unbalanced sex distribution between the two groups,
No randomisation in these studies None and in the other study there was an imbalance in the mean number of teeth requiring
(none of the studies were RCTs) extraction per patient favouring the IHS group.
There is the potential for further
selection bias since patients were pre- Overall risk of bias:
selected for the studies and the
High risk of bias because of potential selection bias.
criteria and numbers were not
reported for some of the studies.
i.e. does not give an accurate estimate
of how many of the patients originally
referred for DGA were then treated
under IHS.
Inconsistency: Refers to unexplained Imprecision (random error): Indirectness: consider i) whether Publication bias:
heterogeneity in results. interventions of interest were compared e.g. when intervention is new and not many
directly or not; ii) whether population studies available- may be biased for positive
characteristics or settings differ from those results
47
Appendix 4 – Evidence Appraisal Forms Systematic Review SR6: Lyratzopoulos and Blain, 2003
of interest
Is heterogeneity analysis reported? n/a The outcomes were compared between None identified other than studies limited to
No formal analysis but noted that: IHS and DGA in the 2 comparator studies English language
and were just reported for IHS in the other
Studies differed in whether a
studies.
comparator was included, in the type
of dental treatment required (e.g. The settings varied with four studies
number of teeth extracted) and the conducted in teaching dental hospitals,
outcomes reported. one in a community clinic, one had a mixed
community and tertiary setting, and the
setting of one study was unclear.
5 of the studies were UK based, 2 were
Scandinavian.
Was meta-analysis conducted? 1. In the two comparative studies, IHS and DGA were effective in 96.7% versus 100% and
No, only a narrative description of the data, with ranges provided for the non-comparator 83.4% versus 98.9% of children, respectively.
studies In the other studies IHS treatment effectiveness ranged from 87% to 96.9%
2. Factors associated with IHS treatment failure were identified as younger age, more teeth
Are results for individual studies shown? Outcome data is stated in the text.
needing to be extracted, poor previous attendance, higher anaesthetic risk status,
Was it reasonable to combine study results? no immaturity and previous negative experience with dental treatment, history of
Was an appropriate method used? n/a psychiatric problems and the occurrence of side effects (data from 3 studies)
Are reasons for variation in results discussed? There did not appear to be appreciable 3. IHS was found to be similar or superior to DGA for morbidity, with only minor side
heterogeneity between study results effects reported, mainly nausea/vomiting and headache. In the other studies, only minor
side effects associated with HIS are reported, mainly nausea/vomiting and headache, in
5–13% of patients (data from 1 comparator study and 3 of the others)
Would confounders affect overall resulta? 4. In the comparative studies the mean procedure time was 22.6 and 45.2 mins for IHS
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
48
Appendix 4 – Evidence Appraisal Forms Systematic Review SR6: Lyratzopoulos and Blain, 2003
Side effects of sedation are one of the study outcomes The benefits of IHS are discussed i.e. the sedative effect of IHS is readily Patient satisfaction with IHS and DGA are one of
reported. Those listed are considered to be minor and reversible and this form of sedation has a high safety record. the reported outcomes.
include nausea/vomiting and headache. The side effects are discussed as an outcome.
Organisational barriers are discussed i.e. the length and number of
sessions.
Costs are a reported outcome and are discussed, with estimates of staff
costs for IHS in a dental teaching hospital setting being 1/3 less than for
DGA.
49
Appendix 4 – Evidence Appraisal Forms Systematic Review SR6: Lyratzopoulos and Blain, 2003
The evidence considered in this systematic review comes mostly from dental teaching hospital setting although it seems likely that the
effectiveness of IHS in a primary care setting would be similar.
50
Appendix 4 – Evidence Appraisal Forms Systematic Review SR7: Papineni McIntosh et al., 2015
Patient/Problem: (target patients Intervention or risk Comparison: Outcomes: note with * those which are critical/important (from patient perspective) for the
and actual participant characteristics) factors: guidance recommendation
Children and adolescents aged 0–16 IV midazolam Other doses and 1. *Minor adverse reactions (defined as any reported adverse events that were non-life-
years of age (including children with routes of midazolam, threatening requiring minimal or no intervention).
specific medical or behavioural other sedatives or 2. *Significant adverse reactions (defined as potentially life-threatening adverse reactions.
problems) undergoing dental placebo. Examples were mortality, inability to maintain an airway or persistent desaturation not
treatment. corrected by head movements.)
51
Appendix 4 – Evidence Appraisal Forms Systematic Review SR7: Papineni McIntosh et al., 2015
Risk of bias/systematic error (study limitations that could cause systematic error): consider risk of bias for each important outcome
Randomisation (selection bias): is it Blinding: consider whether blinding of patients or Other limitations: e.g. attrition bias (incomplete accounting of patients and outcome events),
reported and appropriate (include assessors would be important for outcomes reporting bias (selective outcome reporting), surrogate outcomes(?)
sequence generation and allocation considered 1/5 of the RCTs were crossover studies – some would argue that this design is inappropriate
concealment if possible)? since the behaviour of children undergoing dental procedures and associated side effects
Not reported for individual studies Not reported for individual studies could be influenced by the child's prior experience of dental treatment.
Overall risk of bias:
The overall risk of bias for the 5 RCTs was judged by the SR author to be high.
For the 6 non-randomised studies, the overall risk of bias was judged by the SR author to be
high; three (50%) were retrospective in nature and three (50%) were prospective case series.
Inconsistency: Refers to unexplained Imprecision (random error): Indirectness: consider i) whether Publication bias:
heterogeneity in results. interventions of interest were compared e.g. when intervention is new and not many
directly or not; ii) whether population studies available- may be biased for positive
characteristics or settings differ from those results
of interest
Is heterogeneity analysis reported? Confidence intervals not reported IV midazolam was compared to placebo in No assessment done.
No formal analysis but authors noted some studies and to other doses, routes or
that: other drugs in other studies.
52
Appendix 4 – Evidence Appraisal Forms Systematic Review SR7: Papineni McIntosh et al., 2015
Was it reasonable to combine study results? Yes, for some From the non-RCTs:
Was an appropriate method used? n/a 1. Minor adverse events were recorded (n = 118, 16.8% of cases), with paradoxical
reactions* being the most commonly reported adverse event (n = 89, 12.7% of cases)
Are reasons for variation in results discussed? Yes – see heterogeneity above
2. No significant adverse events were recorded.
The frequency of transient oxygen desaturation was 0% in RCT cases and 0.3% in non-RCT
Would confounders affect overall resulta? cases. This contrasts with the authors previous review on oral midazolam which found that
5.6% of RCT cases and 0.2% of non-RCT experienced transient desaturation.
Data related to the effectiveness of the sedative were not collected.
*Note that paradoxical reactions (e.g. agitation, vocalisation, body movement, crying and the
patient being tearful) can be a result of under-sedation.
Is the effect substantiala? no
Is there dose-response dataa? no
Adverse events are the main theme of this systematic review. Potential harm from IV midazolam is the main theme of the review. The Mentioned that IV route might be less
benefits of midazolam are discussed briefly i.e. midazolam is a short-
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
53
Appendix 4 – Evidence Appraisal Forms Systematic Review SR7: Papineni McIntosh et al., 2015
Side effects of midazolam are listed in the British National acting benzodiazepine which benefits from sedative, acceptable in children.
Formulary for Children as cardiac arrest, heart rate changes, anterograde amnesia and anxiolytic effects.
hypotension, convulsions, anaphylaxis, thrombosis, Other considerations:
laryngospasm, bronchospasm, respiratory depression and
• Disadvantages of the oral route of administration include the lack of
respiratory arrest, gastrointestinal disturbances, dry mouth,
titration, delay of onset and the absence of immediate IV access for
hiccups, increased appetite, jaundice, drowsiness, confusion,
a reversal agent or emergency medication (presumably benefits of
ataxia, amnesia, headache, euphoria, hallucinations,
IV midazolam would be the converse).
dizziness, vertigo, involuntary movements, paradoxical
• For conscious sedation in the UK, oral administration of midazolam
excitement and aggression, dysarthria, urinary retention or
is unlicensed, IV administration is licensed for use in children over 6
incontinence, blood disorders, muscle weakness, visual
months of age.
disturbances including diplopia, salivation changes, skin
• The review reports that there has been an increase in the use of IV
reactions, injection site reactions with intravenous
midazolam sedation in paediatric dental departments across the UK;
administration, and, with intranasal administration, burning
however, many clinicians outside this environment do not routinely
sensation, lacrimation and irritation of nasal mucosa.
offer this service to children. Speculated that this may largely be due
The method of division of these side effects into minor and to the related training difficulties, as well as concern regarding the
significant is subject to debate, as is the inclusion of certain unpredictable reaction of children to midazolam, the acceptability
side effects which may be classed as therapeutic, such as of the intravenous route in children and apprehension of producing
amnesia and drowsiness, which are listed alongside adverse a deeper level of sedation than planned.
side effects.
54
Appendix 4 – Evidence Appraisal Forms Systematic Review SR7: Papineni McIntosh et al., 2015
or dental auxiliary in an outpatient setting or dental office – presumably this could include hospital settings.
55
Appendix 4 – Evidence Appraisal Forms Systematic Review SR8: Papineni et al., 2014
Patient/Problem: (target patients Intervention or risk Comparison: Outcomes: note with * those which are critical/important (from patient perspective) for the
and actual participant characteristics) factors: guidance recommendation
Children and adolescents aged 0–18 Oral midazolam Other doses and 1. *Minor adverse reactions (defined as any reported adverse events that were non-life-
years of age (including children with routes of midazolam, threatening).
specific medical or behavioural other sedatives or 2. *Significant adverse reactions (defined as potentially life-threatening adverse reactions.
problems) undergoing dental placebo. Examples were mortality, inability to maintain an airway or desaturations not corrected
treatment. by head movements.)
56
Appendix 4 – Evidence Appraisal Forms Systematic Review SR8: Papineni et al., 2014
Risk of bias/systematic error (study limitations that could cause systematic error): consider risk of bias for each important outcome
Analysis of bias for the RCTs refers to Lourenco-Matharu et al Cochrane Review 2012 – some are included in 2005 or 2006 versions. However, sources of bias are only reported for 11 of the
16 RCTs.
Randomisation (selection bias): is it Blinding: consider whether blinding of patients or Other limitations: e.g. attrition bias (incomplete accounting of patients and outcome events),
reported and appropriate (include assessors would be important for outcomes reporting bias (selective outcome reporting), surrogate outcomes(?)
sequence generation and allocation considered Only 2/11 of the RCTs assessed in the Cochrane reviews had a low risk of bias from
concealment if possible)? 7 of the 11 RCTs described in the other Cochrane incomplete outcome assessment. For 5/11 studies the risk was high and for the other studies
Although all 16 RCTs should have reviews were double blinded. 1/11 didn’t have the risk was unclear or is not known.
included randomisation, the method blinding. For the other 8 studies blinding is unclear 7 or the 11 RCTs assessed were free of selective reporting. For the others the risk is unknown.
of sequence generation and allocation or unknown.
Only 3 of the 11 RCTs assessed were judged to be at low risk of other bias, for the others the
concealment are unclear or unknown Blinding may not be possible in some of these risk is uncertain or unknown.
(not assessed) for each i.e. unclear risk studies e.g. where comparing different kinds of
of selection bias for all studies. 7/16 RCTs were crossover studies – some would argue that this design is inappropriate since
sedation such as oral midazolam vs N2O.
the behaviour of children undergoing dental procedures and associated side effects could be
influenced by the child's prior experience of dental treatment
Overall risk of bias:
None of the 11 studies assessed by Cochrane were judged as being at low risk of bias overall.
For 5 of the studies at least one domain was assessed as being at high risk of bias. The rest
were assessed as being at unclear risk of bias or the risk of bias is unknown (not assessed).
The risk of bias for the 11 non-randomised studies was judged by the SR author to be high.
Inconsistency: Refers to unexplained Imprecision (random error): Indirectness: consider i) whether Publication bias:
heterogeneity in results. interventions of interest were compared e.g. when intervention is new and not many
directly or not; ii) whether population studies available- may be biased for positive
characteristics or settings differ from those results
of interest
57
Appendix 4 – Evidence Appraisal Forms Systematic Review SR8: Papineni et al., 2014
Is heterogeneity analysis reported? Confidence intervals not reported Oral midazolam was compared to placebo No assessment done.
No formal analysis but noted that: in some studies and to other doses, routes
or other drugs in other studies.
Studies differed widely in the numbers
of reported minor side effects; some
reported none at all and others Locations and settings of populations in
reported high proportions of patients individual studies not stated.
(up to 50%) experiencing them. It is
difficult to explain this solely in terms
of dosage, patient age, or other
factors; it may be that reporting itself
was an issue.
Was it reasonable to combine study results? Yes, for some From the non-RCTs:
Was an appropriate method used? n/a 1. Minor adverse events were more common than major (n = 157, 8% of cases), with
paradoxical reactions* being the most commonly reported side effect (n = 77, 3.8% of
Are reasons for variation in results discussed? Yes – see heterogeneity above
cases)
2. No significant side effects were recorded.
Would confounders affect overall resulta? Data related to the effectiveness of the sedative were not collected.
*Note that paradoxical reactions can be a result of under-sedation.
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
58
Appendix 4 – Evidence Appraisal Forms Systematic Review SR8: Papineni et al., 2014
Adverse events are the main theme of this systematic review. Potential harm from oral midazolam is the main theme of the review. Not discussed
Common side effects include transient desaturations, The benefits of midazolam are discussed briefly i.e. can be administered
hiccough, nausea and vomiting, headache, vertigo, enuresis, orally, has anxiolytic and anterograde amnesic effects and is short acting.
hypersalivation, hallucinations, dizziness, diplopia and
behavioural disinhibition (or paradoxical reaction). Severe
side effects include cardiac arrest, heart rate changes,
anaphylaxis, thrombosis, laryngospasm, bronchospasm,
respiratory depression and respiratory arrest.
59
Appendix 4 – Evidence Appraisal Forms Systematic Review SR9: Davies, 2015
Patient/Problem: (target patients Intervention or risk Comparison: Outcomes: note with * those which are critical/important (from patient perspective) for the
and actual participant characteristics) factors: guidance recommendation
Adults aged 19-80+ years of age Intranasal midazolam Other doses and 1. Effectiveness of delivery method (e.g. liquid drops, spray etc) – measured by
undergoing dental treatment. In some (including by nasal routes of midazolam, bioavailability and plasma concentration
studies, patients had learning drops, liquid or spray) other sedatives or 2. Time taken for sedative effect
difficulties. placebo. 3. *Effectiveness (for dental treatment)#
4. *Side effects (not just from dental studies)
#Only 4 studies were specific to the use of intranasal midazolam for dental treatment
Study Type: Search Strategy: Study selection: No. of selectors: not stated
Appropriate study types? Appropriate search terms? Inclusion criteria:
25 studies met inclusion criteria; 13 Nasal/intranasal plus midazolam expanded terms Studies written in English on the sole use of intranasally administered midazolam on adults,
RCTs, 9 controlled clinical trials, 3 (not limited to dental) that were meta-analyses, randomised controlled trials, systematic reviews, controlled clinical
comparative studies. Search limited to English language, ages from 19 trials or comparative studies.
Of these only 4 looked specifically at to 80+, and comparative studies, controlled clinical
use for dental treatment (1 RCT). trials, RCTs or meta-analysis.
Correct components to address Appropriate databases?
question? Yes Medline, Embase, AMED, PubMed, Web of Science,
Study sizes: Cochrane Database of Systematic Reviews,
Cochrane Central Register of Controlled Trials.
No indication of numbers of
participants in studies Unpublished studies? Not stated
Follow up of citations? Not stated
60
Appendix 4 – Evidence Appraisal Forms Systematic Review SR9: Davies, 2015
Risk of bias/systematic error (study limitations that could cause systematic error): consider risk of bias for each important outcome
Randomisation (selection bias): is it Blinding: consider whether blinding of patients or Other limitations: e.g. attrition bias (incomplete accounting of patients and outcome events),
reported and appropriate (include assessors would be important for outcomes reporting bias (selective outcome reporting), surrogate outcomes(?)
sequence generation and allocation considered Overall risk of bias:
concealment if possible)?
A level of bias risk was assigned to each study, but the basis for this was not described.
Not indicated Only mentioned for 1 study Levels are assigned as low (15 studies) or high risk of bias (10 studies). 2 of the comparative
studies were rated at low levels of risk of bias although if using GRADE, a lack of
randomisation and blinding would be judged as a source of potential bias.
Inconsistency: Refers to unexplained Imprecision (random error): Indirectness: consider i) whether Publication bias:
heterogeneity in results. interventions of interest were compared e.g. when intervention is new and not many
directly or not; ii) whether population studies available- may be biased for positive
characteristics or settings differ from those results
of interest
Is heterogeneity analysis reported? Confidence intervals not reported Only 4 of the studies looked at outcomes No assessment done.
No formal analysis but author noted for dental patients. In 2 of these,
that different delivery methods, doses supplemental i.v. midazolam was also used
and formulations were used. for some patients.
In some of the studies the patients had
learning disabilities.
Locations and settings of populations in
individual studies not stated.
61
Appendix 4 – Evidence Appraisal Forms Systematic Review SR9: Davies, 2015
Are reasons for variation in results discussed? Yes – different delivery methods, doses and longer times may be associated with the use of drops or solutions rather than spray.
formulations mentioned. 3. Effectiveness (for dental treatment): based on 4 studies
(i) reduced anxiety with intranasal midazolam, although this study was likely to rate as
low quality by GRADE
Would confounders affect overall resulta?
(ii) improved patient compliance following intranasal midazolam compared to no
treatment (RCT with low risk of bias therefore likely to be moderate quality by GRADE)
(iii) in an audit of intranasal sedation (plus i.v. where required) for adult patients with
learning disabilities, the patient was fully cooperative in 58% of episodes (222 in total)
(minimal interference for 34%, 9% impossible to treat) – previously i.v. sedation alone
had not been possible for the patients included in this audit (likely to be rated low
quality evidence by GRADE). i.e. improved patient compliance compared to no treament.
(iv) in a related prospective audit, venous cannulation (for i.v. midazolam) was achieved
following intranasal midazolam in 96% of treatment episodes (71% of patients in the
audit had learning disabilities); likely to rate as low quality evidence
4. Side effects (not just from dental studies): nasal burning and irritation, lacrimation,
discomfort in the mouth, bad taste, sneezing, coughing, dry mouth, nausea and oxygen
desaturation were reported adverse effects. Side effects were short-lived.
Is the effect substantiala? no
Is there dose-response dataa? no
Adverse events are reported. The benefits of intranasal midazolam are discussed i.e. needle-free, Acceptability of intranasal midazolam as an
patient friendly means of drug delivery. Side effects are also discussed alternative to intravenous routes is a main
and it is noted that most are short-lived and not severe. Oxygen theme.
desaturation was the most significant and could be addressed with
supplemental oxygen.
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
62
Appendix 4 – Evidence Appraisal Forms Systematic Review SR9: Davies, 2015
63
Appendix 4 – Evidence Appraisal Forms Guideline G1: AoMRC, 2013
Aim(s) of guidance:
This document aims to give guidance for the safe use of conscious sedation techniques by healthcare professionals to facilitate diagnostic and therapeutic healthcare procedures.
The report defines Fundamental Standards and Development Standards in safe sedation practice and recommends competency-based formal training for all healthcare professionals
involved in sedation.
64
Appendix 4 – Evidence Appraisal Forms Guideline G1: AoMRC, 2013
Geographical setting for guidance: Healthcare setting for guidance: Is guidance currently used?
users and patients
Patient/Problem: (target patients Intervention or risk Comparison: Outcomes: note with * those which are critical/important (from patient
and actual participant characteristics) factors: perspective) for the guidance recommendation
Patients receiving sedation to facilitate Sedation Not known Various indicators of adverse events
diagnostic and therapeutic healthcare e.g. over-dose of sedative, use or reversal agent
procedures
Appropriate study types? Appropriate search terms? No search described Inclusion criteria:
Includes audits and prospective
65
Appendix 4 – Evidence Appraisal Forms Guideline G1: AoMRC, 2013
Randomisation: is it reported and Blinding: consider whether blinding of patients or assessors Other limitations: e.g. attrition bias (incomplete accounting of patients and
appropriate? would be important for outcomes considered outcome events), reporting bias (selective outcome reporting), surrogate
Not described Not described outcomes(?)
Not described
Inconsistency: Refers to unexplained Imprecision (random error): Indirectness: consider i) whether Publication bias:
heterogeneity in results. interventions of interest were compared e.g. when intervention is new and not many studies
directly or not; ii) whether population available- may be biased for positive results
characteristics or settings differ from those
of interest
Not described Not described The audit evidence discussed mainly Not described
refers to endoscopy.
Are results for individual studies shown? no There was very little data reported and most was descriptive.
Was it reasonable to combine study results? n/a
Was an appropriate method used? Is the effect substantiala?
Is there dose-response dataa?
66
Appendix 4 – Evidence Appraisal Forms Guideline G1: AoMRC, 2013
Adverse events (particularly for The guideline acknowledges that: Not mentioned
endoscopy) were discussed as the By relieving anxiety, reducing pain and providing amnesia,
justification for the guideline. sedation techniques have the potential to render
uncomfortable diagnostic and therapeutic procedures more
acceptable for patients. However, it must be accepted that
these techniques also have the potential to cause life-
threatening complications.
Overall quality of guidance (AGREE II) and explanation: Rating of recommendations: Should the recommendations made be considered for
SDCEP guidance?
Overall quality = 4/7 (moderate) AGREE appraisals available on request The evidence was not appraised in any way. The audit reports and surveys on adverse events
This is a moderate quality guideline. The recommendations appear to be based on would be likely to be considered low to very low quality evidence if appraised using GRADE,
other guidelines and expert opinion. There is some information presented on adverse because of the study type.
events, mostly in endoscopy. There is no indication of a systematic search to source The strength of the recommendations is not stated (i.e. weak or strong) although the words
information to inform the recommendations was carried out and no consideration of ‘should’, ‘must’, may be’ etc could be used as indicators of strength.
the quality of the evidence cited to support the guideline.
The strength of the recommendations is not explicitly stated (i.e. weak or strong) The recommendations relevant to dental sedation included in this guideline may be considered
although the words ‘should’, ‘do not’, ‘consider’, ‘ensure’ etc are used to indicate for supporting recommendations in the updated SDCEP guidance.
strength.
Reviewer’s comments:
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
67
Appendix 4 – Evidence Appraisal Forms Guideline G1: AoMRC, 2013
The information on adverse events may not have included sedation for dental procedures.
There are some recommendations made in the guideline that are specific to dentistry, particularly those referring to the number of sedation trained staff:
It is deemed acceptable in some specialties, e.g. dentistry, that, where conscious sedation is the target state, a second individual already responsible for monitoring the patient may assist
the operator-sedationist with interruptible ancillary tasks of short duration, no third person being required.
68
Appendix 4 – Evidence Appraisal Forms Guideline G2: ADA, 2012a
• Experienced practitioners with a high degree of competency gained through a combination of instruction and experience are assumed to meet the educational criteria described.
• Aim to provide a consistent measure of acceptable predoctoral and continuing education but is not intended to fit every program into the same rigid educational mold. This is neither
possible nor desirable. There must always be room for innovation and improvement.
• Includes an extensive list of definitions under headings: Methods of Anxiety and Pain Control (analgesia, conscious sedation, combination inhalation-enteral conscious sedation,
local anaesthesia, minimal sedation, moderate sedation, titration, deep sedation, general anaesthesia); Routes of Administration (enteral, parenteral, transdermal, transmucosal,
inhalation); Terms (qualified dentist, must/shall, should, may, continual, continuous, time-oriented anaesthesia record, immediately available); ASA Physical Status Classification.
Educational Courses (Competency courses, update courses, survey courses, advanced education courses)
• Detailed recommendation describing the objectives, content and delivery of courses are provided under the following headings:
Teaching Pain Control Recommendations
General objectives; Curriculum Content; Sequence of Didactic and Clinical Instruction; Faculty; Facilities
Teaching Administration of Minimal Sedation General objectives
Inhalation Sedation (Nitrous Oxide/Oxygen) objectives and course content, duration (min 14 hours + clinical component); participant evaluation and documentation; faculty; facilities
Enteral and/or Combination Inhalation-enteral Minimal Sedation objectives and course content, duration (min 16 hours + clinical experiences); participant evaluation and
documentation; faculty; facilities
Teaching Administration of Moderate Sedation General objectives; course content; Enteral moderate sedation course duration (min 24 hours plus management of at least 10 adult
69
Appendix 4 – Evidence Appraisal Forms Guideline G2: ADA, 2012a
case experiences, including 3 live patients + simulations/video); Parenteral moderate sedation course duration (min 60 hours plus management of at least 20 adult cases); participant
evaluation and documentation; faculty; facilities
Geographical setting for guidance: Healthcare setting for guidance: Is guidance currently used?
users and patients
Guidelines developed by American Society. Not clearly stated. Most recent therefore likely to be.
Patient/Problem: (target patients and actual Intervention or risk factors: Comparison: Outcomes: note with * those which are critical/important (from patient
participant characteristics) perspective) for the guidance recommendation
Randomisation: is it reported and Blinding: consider whether blinding of patients or assessors would be Other limitations: e.g. attrition bias (incomplete accounting of patients
appropriate? important for outcomes considered and outcome events), reporting bias (selective outcome reporting),
Not described Not described surrogate outcomes(?)
No details provided.
70
Appendix 4 – Evidence Appraisal Forms Guideline G2: ADA, 2012a
Inconsistency: Refers to unexplained Imprecision (random error): Indirectness: consider i) whether interventions Publication bias:
heterogeneity in results. of interest were compared directly or not; ii) e.g. when intervention is new and not many
whether population characteristics or settings studies available- may be biased for positive
differ from those of interest results
Overall quality of guidance (AGREE II) and explanation: Rating of recommendations: Should the recommendations made be considered for SDCEP
guidance?
Overall quality = 2/7 (Low) AGREE appraisals available on request. Due to the poor methodology employed, these recommendations should not be used as the
This is a low quality guideline. The methodology used to develop this guideline appears basis for making recommendations in SDCEP guidance. However, if SDCEP guidance
recommendations are consistent with these recommendations, this guideline could be cited as
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
71
Appendix 4 – Evidence Appraisal Forms Guideline G2: ADA, 2012a
to be very weak (i.e. not reported). Recommendations are relatively easy to find and are such.
fairly unambiguous. The guideline is concise. There is no discussion of barriers,
implementation, patient views etc.
Reviewer’s comments:
This is one of three ADA documents related to the provision of sedation. The guideline does not discuss choice of sedation technique.
The absence of a reported methodology is a major weakness. The recommendations are fairly clear, unambiguous and likely to be consistent with practice in the UK with regard to minimal
and moderate sedation only.
It would not be appropriate to base recommendations for the UK on this guideline but it might be useful to cite it as verification of recommendations if they are consistent.
SDCEP guidance themes: sedation techniqueX, patient selectionX, recordsX, consentX, training✓, monitoringX, fastingX, environmentX, equipmentX, staffing✓, patient viewsX
(✓) indicated mentioned but not in detail.
Relevant changes
No longer includes children in the scope – refers to AAPD 2016 updated guideline (see appraisal form for G10).
Only minimal and moderate sedation are defined.
Maintenance of sedation equipment has been added to the course content.
The sections covering teaching of enteral and parenteral moderate sedation have been combined.
The update recommends that the course director should hold a current permit or license to administer moderate sedation (for teaching minimal sedation) or moderate or deep sedation
and general anaesthesia (for teaching moderate sedation).
Appraisal
As for the 2012 version, the 2016 update does not describe the methodology used and there is no discussion of barriers, implementation or patient views. The recommendations are
presented in a similar way to the 2012 version. Consequently, the 2016 update would also rate, using the AGREE II tool, as 2/7 (Low quality).
72
Appendix 4 – Evidence Appraisal Forms Guideline G3: ADA, 2012b
• Includes an extensive list of definitions under headings: Methods of Anxiety and Pain Control (analgesia, conscious sedation, combination inhalation-enteral conscious sedation,
local anaesthesia, minimal sedation, moderate sedation, titration, deep sedation, general anaesthesia); Routes of Administration (enteral, parenteral, transdermal, transmucosal,
inhalation); Terms (qualified dentist, must/shall, should, may, continual, continuous, time-oriented anaesthesia record, immediately available); ASA Physical Status Classification.
• Lists educational requirements (including life support training) for the dentist administering minimal sedation; moderate sedation; deep sedation or GA.
• Minimal Sedation recommendations related to: Patient evaluation; Pre-operative preparation; Personnel (including training) and Equipment Requirements; Monitoring (oxygenation;
ventilation; circulation) and Documentation; Recovery and Discharge; Emergency Management; Management of Children.
• Moderate Sedation recommendations as for minimal sedation plus: equipment necessary to establish intravenous access must be available; enhanced staffing requirements for
monitoring; monitoring of consciousness; enhanced documentation; additional procedures if a reversal agent has been used.
• Deep Sedation and GA recommendations as for moderate sedation plus: pre-op securing of an IV line; additional personnel; equipment for enhanced airway management and
cardiac life support; monitoring of temperature; additional considerations for pediatric and special needs patients; additional emergency management measures.
Geographical setting for guidance: Healthcare setting for guidance: Is guidance currently used?
users and patients
Guidelines developed by American Society. Not clearly stated. Most recent therefore likely to be.
73
Appendix 4 – Evidence Appraisal Forms Guideline G3: ADA, 2012b
Patient/Problem: (target patients and actual Intervention or risk factors: Comparison: Outcomes: note with * those which are critical/important (from patient
participant characteristics) perspective) for the guidance recommendation
Randomisation: is it reported and Blinding: consider whether blinding of patients or assessors would be Other limitations: e.g. attrition bias (incomplete accounting of patients
appropriate? important for outcomes considered and outcome events), reporting bias (selective outcome reporting),
Not described Not described surrogate outcomes(?)
No details provided.
Inconsistency: Refers to unexplained Imprecision (random error): Indirectness: consider i) whether interventions Publication bias:
heterogeneity in results. of interest were compared directly or not; ii) e.g. when intervention is new and not many
whether population characteristics or settings studies available- may be biased for positive
differ from those of interest results
74
Appendix 4 – Evidence Appraisal Forms Guideline G3: ADA, 2012b
Overall quality of guidance (AGREE II) and explanation: Rating of recommendations: Should the recommendations made be considered
for SDCEP guidance?
Overall quality = 2/7 (low) AGREE appraisals are available on request. Due to the poor methodology employed, these recommendations should not be used as
This is a low quality guideline. The methodology used to develop this guideline appears to be the basis for making recommendations in SDCEP guidance. However, if SDCEP guidance
very weak (i.e. not reported). Recommendations are relatively easy to find and are fairly recommendations are consistent with these recommendations, this guideline could be
unambiguous. The guideline is concise. There is no discussion of barriers, implementation, cited as such.
patient views etc.
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
75
Appendix 4 – Evidence Appraisal Forms Guideline G3: ADA, 2012b
Reviewer’s comments:
This is one of three ADA documents related to the provision of sedation. The guideline does not discuss choice of sedation technique.
The absence of a reported methodology is a major weakness. The recommendations are fairly clear, unambiguous and likely to be consistent with practice in the UK with regard to minimal
and moderate sedation only.
It would not be appropriate to base recommendations for the UK on this guideline but it might be useful to cite it as verification of recommendations if they are consistent.
SDCEP guidance themes: sedation techniqueX, patient selection✓, records✓, consent✓, training✓, monitoring✓, fasting(✓), environmentX, equipment✓, staffing✓, patient viewsX
(✓) indicated mentioned but not in detail.
Relevant changes
No longer includes children in the scope – refers to AAPD 2016 updated guideline (see appraisal form for G10).
Definitions have been amended and no longer include conscious sedation.
Some of the details of the recommendations for each level of sedation have been amended:
Minimal Sedation: baseline vital signs expanded to specify body weight, height, blood pressure, pulse rate and respiration rate (also body temperature when clinically indicated);
documentation of equipment maintenance and pre-procedural checks have been added to equipment requirements; level of sedation has been added to monitoring.
Moderate Sedation: BMI now recommended as part of assessment; baseline vital signs expanded to specify body weight, height, blood pressure, pulse rate, respiration rate and oxygen
saturation (also body temperature when clinically indicated); fasting instuctions are now recommended in patient instructions; documentation of equipment maintenance, pre-procedural
checks and the requirement for capnography equipment have been added; monitoring of end-tidal CO2 has been added.
Deep Sedation or General Anaesthestic: these recommendations have also been updated but are not included in the scope of the SDCEP guidance.
Appraisal
As for the 2012 version, the 2016 update does not describe the methodology used and there is no discussion of barriers, implementation or patient views. The recommendations are
presented in a similar way to the 2012 version. Consequently, the 2016 update would also rate, using the AGREE II tool, as 2/7 (Low quality).
76
Appendix 4 – Evidence Appraisal Forms Guideline G5: ANZCA,
2014
Guideline G5: Australian and New Zealand College of Anaesthetists (ANZCA), 2014
Date of publication/revision: 2014 Original version: Promulgated: (as P9) 1984 Source: http://www.anzca.edu.au/Documents/ps09-2014-guidelines-on-
Reviewed: 1986, 1991, 1996, 2001, 2005, sedation-and-or-analgesia.pdf
2007, 2008, 2010, 2014
Aim(s) of guidance:
The aim is not very clearly stated but the implication is that it is to promote best practice in sedation for various procedures:
This document is intended to apply wherever procedural sedation and/or analgesia for diagnostic and interventional medical, dental and surgical procedures are administered, but excludes
situations where sedation is used for longer term management of patients such as in intensive care units or for psychiatrically disturbed patients. The Australian and New Zealand College of
Anaesthetists (ANZCA) and all co-signing colleges/societies recognise that practitioners with diverse qualifications and training are administering a variety of medications to patients to
allow such procedures to be performed. This document addresses pertinent issues for all practitioners involved in such activities.
ANZCA’s website states: ANZCA's professional documents are crucial for promoting the safety and quality of patient care for those undergoing anaesthesia for surgical and other procedures.
77
Appendix 4 – Evidence Appraisal Forms Guideline G5: ANZCA,
2014
Training
Audit
Geographical setting for guidance: Healthcare setting for guidance: Is guidance currently used?
users and patients
Guidelines developed in Australia but lists articles from other Applicable for all patients where Don’t know, but is regularly updated, so likely to be in use.
countries including UK guidelines. procedural sedation and/or analgesia
for diagnostic and interventional
medical, dental and surgical
procedures are administered.
Patient/Problem: (target patients Intervention or risk Comparison: Outcomes: note with * those which are critical/important (from patient
and actual participant characteristics) factors: perspective) for the guidance recommendation
Patients requiring procedural sedation Sedation and/or analgesia None made Not stated but presumable includes effectiveness and safety.
and/or analgesia for diagnostic and
interventional medical, dental and
surgical procedures.
78
Appendix 4 – Evidence Appraisal Forms Guideline G5: ANZCA,
2014
Study sizes:
Risk of bias/systematic error (study limitations that could cause systematic error): consider risk of bias for each important outcome
Randomisation: is it reported and Blinding: consider whether blinding of patients or assessors Other limitations: e.g. attrition bias (incomplete accounting of patients and
appropriate? would be important for outcomes considered outcome events), reporting bias (selective outcome reporting), surrogate
Study data not described Study data not described outcomes(?)
Study data not described
Inconsistency: Refers to unexplained Imprecision (random error): Indirectness: consider i) whether Publication bias:
heterogeneity in results. interventions of interest were compared e.g. when intervention is new and not many studies
directly or not; ii) whether population available- may be biased for positive results
characteristics or settings differ from those
of interest
Study data not described Study data not described Study data not described Study data not described
79
Appendix 4 – Evidence Appraisal Forms Guideline G5: ANZCA,
2014
Potential risks: The aims and risks for procedural sedation are clearly None mentioned.
2.2.1 Depression of protective airway described. The guideline indicates that the recommendations
reflexes and loss of airway patency. should be followed to ensure patient safety i.e. have taken the
risks into consideration.
2.2.2 Depression of respiration.
Costs considerations related to any area of sedation provision
2.2.3 Depression of the cardiovascular
are not mentioned.
system.
2.2.4 Drug interactions or adverse
reactions, including anaphylaxis.
2.2.5 Unexpectedly high sensitivity to
the drugs used for procedural sedation
and/or analgesia which may result in
unintentional loss of consciousness,
and respiratory or cardiovascular
depression.
2.2.6 Individual variations in response
to the drugs used, particularly in
children, the elderly, and those with
pre-existing disease.
2.2.7 The possibility of deeper sedation
or anaesthesia being used to
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
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Appendix 4 – Evidence Appraisal Forms Guideline G5: ANZCA,
2014
Overall quality of guidance (AGREE II) and explanation: Rating of recommendations: Should the recommendations made be considered for
SDCEP guidance?
Overall quality = 3/7 (low) AGREE appraisals are available on request. There is no indication that the evidence has been formally appraised for quality and the basis for
This is a fairly low quality guideline according to AGREE criteria. Although other and strength of the recommendations is not stated.
documents on the ANZCA website suggest that appropriate methodology may be used This guideline should not on its own be considered as a strong basis for informing
e.g. evidence searching, expert involvement, consultation, conflict of interest, reviewing recommendations in the updated SDCEP guidance.
etc, specific details are not provided for the guideline so it is not clear that those
methods were applied. The most significant concern with the guideline is the lack of
provision of any link between the evidence and the recommendations.
Reviewer’s comments:
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Appendix 4 – Evidence Appraisal Forms Guideline G6: SCSD, 2007
Aim(s) of guidance:
The combined guidance is designed to provide practitioners with the information they need to ensure they provide conscious sedation services to the specified standards in order to
safeguard patients regardless of the clinical setting. The standards set out in this guideline are the minimum requirements.
The aim is to ensure that effective treatment given to patients is provided safely and that it is well within the competencies of the dentist / sedationist, dedicated sedationist and whole
practice care team.
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Appendix 4 – Evidence Appraisal Forms Guideline G6: SCSD, 2007
• combined (non-sequential) routes for example: intravenous + inhalational agent (except for the use of nitrous oxide / oxygen during cannulation)
# It is recognised that the physical and mental development of individuals varies and may not necessarily correlate with the chronological age
Recommendations are made on:
Environment requirements including premises, drugs & equipment (sedation, monitoring, management of complications and resuscitation), the team (number of staff), the patient,
documentation & protocols (including consent, patient and escort instructions).
Qualification requirements (essential and desirable)
Experience requirements (for entry into training in specific alternative techniques)
Geographical setting for guidance: Healthcare setting for guidance: Is guidance currently used?
users and patients
Guidelines developed in UK Dental and medical practitioners including Possibly – may have been considered to have been superseded by IACSD 2015
anaesthetists and their teams, who carry out report.
alternative techniques of dental sedation (refers to
any clinical setting).
Although not stated explicitly, refers to all patients
(including children) requiring alternative dental
sedation techniques.
Patients requiring alternative sedation Alternative sedation Not known No details provided.
techniques for dental treatment. techniques
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Appendix 4 – Evidence Appraisal Forms Guideline G6: SCSD, 2007
Inconsistency: Refers to unexplained Imprecision (random error): Indirectness: consider i) whether Publication bias:
heterogeneity in results. interventions of interest were compared e.g. when intervention is new and not many studies
directly or not; ii) whether population available- may be biased for positive results
characteristics or settings differ from those
of interest
Not described Not described Evidence not described. No information on how information was sought.
Are results for individual studies shown? no There was no data reported.
Was it reasonable to combine study results? n/a Is the effect substantiala?
Was an appropriate method used? Is there dose-response dataa?
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
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Appendix 4 – Evidence Appraisal Forms Guideline G6: SCSD, 2007
Overall quality of guidance (AGREE II) and explanation: Rating of recommendations: Should the recommendations made be considered for
SDCEP guidance?
Overall quality = 3/7 (low) AGREE appraisals are available on request. It is not clear whether this document should be considered to be guidance or standards and
This report has a relatively low score because it fails to meet a number of AGREE whether mandatory. The focus seems to be on quality assurance although there are
criteria. This may be in part because its purpose may be more as guidance on achieving recommendations made for practice. Much of the detail of these is provided in the inspection
quality assurance around standards rather than as a clinical practice guideline. checklist in Annex 3.
Reviewer’s comments:
The basis for the ‘recommendations’ provided in this document is not clear.
85
Appendix 4 – Evidence Appraisal Forms Guideline G8: AAPD, 2013
Geographical setting for guidance: Healthcare setting for guidance: Is guidance currently used?
users and patients
Guidelines developed by American association but include Applicable for children (age not Not known, but is regularly updated, so likely to be in use.
studies published outwith the USA. defined).
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Appendix 4 – Evidence Appraisal Forms Guideline G8: AAPD, 2013
Patient/Problem: (target patients Intervention or risk Comparison: Outcomes: note with * those which are critical/important (from patient
and actual participant characteristics) factors: perspective) for the guidance recommendation
Patient with indications for N2O N2O None made Not stated but inferred outcomes are:
sedation 1. Effectiveness for analgesia/anxiolysis
2. Safety
3. Acceptability by children
4. Facilitation of dental treatment
5. Side effects
Appropriate study types? Appropriate search terms? Yes although Inclusion criteria:
The 40 articles retrieved should have basic Not stated
been clinical trials according to the Appropriate databases? Pubmed only Exclusion criteria:
search criteria, but the data from the
Unpublished studies? no Not stated
studies is not presented.
Follow up of citations? Not stated
Correct components to address
question? Personal contact with experts? Not stated
Study sizes: Nb search limited to studies in English, last 10 years and clinical
trials
Risk of bias/systematic error (study limitations that could cause systematic error): consider risk of bias for each important outcome
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Appendix 4 – Evidence Appraisal Forms Guideline G8: AAPD, 2013
Randomisation: is it reported and Blinding: consider whether blinding of patients or assessors Other limitations: e.g. attrition bias (incomplete accounting of patients and
appropriate? would be important for outcomes considered outcome events), reporting bias (selective outcome reporting), surrogate
Study data not described Study data not described outcomes(?)
Study data not described.
Limitations of search strategy is highly likely to have biased the results obtained.
Inconsistency: Refers to unexplained Imprecision (random error): Indirectness: consider i) whether Publication bias:
heterogeneity in results. interventions of interest were compared e.g. when intervention is new and not many studies
directly or not; ii) whether population available- may be biased for positive results
characteristics or settings differ from those
of interest
Study data not described Study data not described Not clear if studies were relevant to Only considered articles in English and search was not
children. extensive. Publication bias likely.
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
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Appendix 4 – Evidence Appraisal Forms Guideline G8: AAPD, 2013
Nausea and vomiting listed as most Safety and adverse effects are considered. The environmental Patient experiences of N2O administration are discussed:
common. impact of N2O use is discussed, as is occupational safety. Stated that Nitrous oxide generally is acceptable to children and can be titrated
Diffusion hypoxia can lead to Costs considerations related to any area of N2O sedation easily. Most children are enthusiastic about the administration of nitrous
headache and disorientation. provision are not mentioned. oxide/oxygen; many children report dreaming or being on a “space-ride”. For
some patients, however, the feeling of “losing control” may be troubling and
claustrophobic patients may find the nasal hood confining and unpleasant.
Overall quality of guidance (AGREE II) and explanation: Rating of recommendations: Should the recommendations made be considered for
SDCEP guidance?
Overall quality = 3/7 (low) AGREE appraisals are available on request. The authors do not use GRADE or an alternative and although the recommendations reference
This is a fairly low quality guideline according to AGREE criteria. Although some published articles retrieved by database searches, there is no indication that the evidence has
searching for evidence has been carried out, the studies are only referenced in the text been formally appraised for quality. There is no indication of the strength of the
with little or no reporting of the study details or data or assessment of the quality of recommendations.
the evidence. The recommendations are not clearly linked to the evidence or the There is not a strong basis for using these recommendations. However, if SDCEP guidance
underlying basis for each (e.g. expert opinion) indicated. recommendations are consistent with these recommendations, this guideline could be cited as
There is no indication of evidence quality or recommendation strength. A number of such.
other criteria for guideline quality are not met satisfactorily.
Reviewer’s comments:
The authors conclude that: When administered by trained personnel on carefully selected patients with appropriate equipment and technique, nitrous oxide is a safe and effective agent for
providing pharmacological guidance of behavior in children.
No clear link between recommendations and evidence. However, the authors state in methods that recommendations may be based on expert and/or consensus opinion.
Very little detail is provided regarding recommendations for training.
If used, the individual recommendations (e.g. for emergency equipment) should be checked for their applicability in the UK.
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Appendix 4 – Evidence Appraisal Forms Guideline G10: AAPD, 2011
• Defines terms including Minimal sedation and Moderate sedation (old terminology conscious sedation or sedation/analgesia): a drug-induced depression of consciousness during
which patients respond purposefully to verbal commands (eg, open your eyes either alone or accompanied by light tactile stimulation—a light tap on the shoulder or face, not a sternal
rub, Deep Sedation and General anesthesia).
• It is beyond the scope of this document to specify which drugs are appropriate for which procedures; however, the selection of the fewest number of drugs and matching drug
selection to the type and goal of the procedure are essential for safe practice.
• Responsible person: The pediatric patient shall be accompanied to and from the treatment facility by a parent, legal guardian, or other responsible person.
• Facilities: The practitioner who uses sedation must have immediately available facilities, personnel, and equipment to manage emergency and rescue situations.
• Back-up emergency services: A protocol for access to back-up emergency services shall be clearly identified, with an outline of the procedures necessary for immediate use.
• On-site monitoring and rescue equipment: An emergency cart or kit must be immediately accessible and contain equipment to provide the necessary age- and size-appropriate
drugs and equipment to resuscitate a non-breathing and unconscious child. All equipment and drugs must be checked and maintained on a scheduled basis. Monitoring devices, e.g.
ECG machines, pulse oximeters, end-tidal carbon dioxide monitors, and defibrillators (with size-appropriate defibrillator paddles), must have a safety and function check on a regular
basis as required by local or state regulation.
• Documentation before sedation: to include Informed consent; Instructions and information supplied to responsible person (see guideline for details); A 24-hour contact telephone
number; Limitations of activities and appropriate dietary precautions.
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Appendix 4 – Evidence Appraisal Forms Guideline G10: AAPD, 2011
• Dietary precautions: Children receiving sedation for elective procedures should generally follow the same fasting guidelines as before general anesthesia (because the absolute risk of
aspiration during procedural sedation is not yet known) –details are provided in the guideline; for emergency procedures in children who have not fasted, the risks of sedation and the
possibility of aspiration must be balanced against the benefits of performing the procedure promptly.
• Documentation at the time of sedation: 1) Pre-sedation health evaluation (see guideline for extensive details); 2) Prescriptions for sedation
• Documentation during treatment: The patient’s chart shall contain a time-based record that includes the name, route, site, time, dosage, and patient effect of administered drugs
(see guideline for details). Adverse events and their treatment shall be documented.
• Documentation after treatment: The time and condition of the child at discharge from the treatment area or facility shall be documented; this should include documentation that the
child’s level of consciousness and oxygen saturation in room air have returned to a state that is safe for discharge by recognized criteria.
• Continuous quality improvement: each facility should maintain records that track adverse events and examine these for assessment of risk reduction and improvement in patient
satisfaction.
• Preparation and setting up for sedation procedures: use a systematic approach e.g. SOARME acronym.
• Minimal sedation: Children who have received minimal sedation generally will not require more than observation and intermittent assessment of their level of sedation.
• Moderate sedation: The drugs and techniques used should carry a margin of safety wide enough to render unintended loss of consciousness highly unlikely. The practitioner
responsible for the treatment of the patient and/or the administration of drugs for sedation must be competent to use such techniques, to provide the level of monitoring provided in
this guideline, and to manage complications of these techniques (ie, to be able to rescue the patient). Because the level of intended sedation may be exceeded, the practitioner must be
sufficiently skilled to provide rescue should the child progress to a level of deep sedation. The practitioner must be trained in, and capable of providing, at the minimum, bag-valve-
mask ventilation so as to be able to oxygenate a child who develops airway obstruction or apnea. Training in, and maintenance of, advanced pediatric airway skills is required; regular
skills reinforcement is strongly encouraged.
Support personnel The use of moderate sedation shall include provision of a person, in addition to the practitioner, whose responsibility is to monitor appropriate physiologic
parameters and to assist in any supportive or resuscitation measures, if required. This individual may also be responsible for assisting with interruptible patient-related tasks of short
duration. This individual must be trained in and capable of providing pediatric basic life support.
Monitoring and documentation: baseline vital signs if possible; during the procedure documentation of the name, route, site, time of administration, and dosage of all drugs
administered. There shall be continuous monitoring of oxygen saturation and heart rate and intermittent recording of respiratory rate and blood pressure; these should be re-corded in
a time-based record. The child’s head position should be checked frequently to ensure airway patency.
After the procedure: The child who has received moderate sedation must be observed in a suitably equipped recovery facility [eg, the facility must have functioning suction apparatus
as well as the capacity to deliver more than 90 percent oxygen and positive-pressure ventilation (eg, bag and mask with oxygen capacity as described previously)]. The patient’s vital
signs should be recorded at specific intervals. If the patient is not fully alert, oxygen saturation and heart rate monitoring shall be used continuously until appropriate discharge criteria
are met.
• Deep sedation: There must be one person available whose only responsibility is to constantly observe the patient’s vital signs, airway, patency, and adequacy of ventilation and to
either administer drugs or direct their administration. At least one individual must be present who is trained in, and capable of, providing advanced pediatric life support, and who is
skilled in airway management and cardiopulmonary resuscitation; training in pediatric advanced life support is required. Additional equipment: an electrocardiographic monitor and a
defibrillator for use in pediatric patients. Monitoring as for moderate sedation with vital signs, including oxygen saturation and heartrate documented at least every five minutes in a
time-based record. Post-sedation care as for moderate sedation.
• Special considerations: To ensure that the patient will not receive an excessive dose of local anesthetic, the maximum allowable safe dosage (ie, mg/kg) should be calculated before
administration. It is essential that any oximeter probe is positioned properly. The use of expired carbon dioxide monitoring devices (capnography) is encouraged for sedated children,
particularly in situations where other means of assessing the adequacy of ventilation are limited. Familiarity with various adjuncts to airway management and resuscitation and
intraosseous needles, training with patient simulators, is encouraged.
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Appendix 4 – Evidence Appraisal Forms Guideline G10: AAPD, 2011
• Nitrous oxide: Inhalation sedation/analgesia equipment that delivers nitrous oxide must have the capacity of delivering 100 percent and never less than 25 percent oxygen
concentration at a flow rate appropriate to the size of the patient. Equipment that delivers variable ratios of nitrous oxide to oxygen and that has a delivery system that covers the
mouth and nose must be used in conjunction with a calibrated and functional oxygen analyzer. The use of nitrous oxide for minimal sedation is defined as the administration of nitrous
oxide (50 percent or less) with the balance as oxygen, without any other sedative, narcotic, or other depressant drug before or concurrent with the nitrous oxide to an otherwise healthy
patient in ASA class I or II. The patient is able to maintain verbal communication throughout the procedure. If nitrous oxide in oxygen is combined with other sedating medications,
such as chloral hydrate, midazolam, or an opioid, or if nitrous oxide is used in concentrations greater than50 percent, the likelihood for moderate or deep sedation increases.
• Appendices provide recommended discharge criteria; ASA Physical Classification; Drugs that may be needed to rescue a sedated patient; emergency equipment.
Geographical setting for guidance: Healthcare setting for guidance: Is guidance currently used?
users and patients
Guidelines developed by American Society but include This guideline is intended for all venues Most recent therefore likely to be in use.
studies published in journals outside of the US. in which sedation for a procedure
might be performed (hospital, surgical
center, freestanding imaging facility,
dental facility, or private office).
Patient/Problem: (target patients and actual Intervention or risk Comparison: Outcomes: note with * those which are critical/important (from patient
participant characteristics) factors: perspective) for the guidance recommendation
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Appendix 4 – Evidence Appraisal Forms Guideline G10: AAPD, 2011
Risk of bias/systematic error (study limitations that could cause systematic error): consider risk of bias for each important outcome
Randomisation: is it reported and Blinding: consider whether blinding of patients or assessors Other limitations: e.g. attrition bias (incomplete accounting of patients and
appropriate? would be important for outcomes considered outcome events), reporting bias (selective outcome reporting), surrogate
Risk of bias and other limitations are Not described outcomes(?)
not explicitly considered for each study. No details provided.
Inconsistency: Refers to unexplained Imprecision (random error): Indirectness: consider i) whether Publication bias:
heterogeneity in results. interventions of interest were compared e.g. when intervention is new and not many studies
directly or not; ii) whether population available- may be biased for positive results
characteristics or settings differ from those of
interest
No heterogeneity analysis. Not reported. Unclear if study selection focussed on studies Search was limited therefore publication bias is very
of child patients. likely.
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
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Appendix 4 – Evidence Appraisal Forms Guideline G10: AAPD, 2011
Overall quality of guidance (AGREE II) and explanation: Rating of recommendations: Should the recommendations made be considered for
SDCEP guidance?
Overall quality = 2/7 (low) AGREE appraisals are available on request. Due to the poor methodology employed, these recommendations should not be used as the basis
This is a low quality guideline. The methodology used to develop this guideline for making recommendations in SDCEP guidance. However, if SDCEP guidance recommendations
appears to be weak (i.e. not reported). Recommendations are relatively easy to find are consistent with these recommendations, this guideline could be cited as such.
and are fairly unambiguous. The guideline is concise. There is no discussion of barriers,
implementation, patient views etc.
Reviewer’s comments:
This is an update of a guideline first published in 2005 that was written to unify guidelines for sedation used by medical and dental practitioners. It consequently superseded other
publications (e.g. AAPD Guideline on elective use of minimal, moderate and deep sedation and general anesthesia for pediatric dental patients, 2005).
The absence of a reported methodology is a weakness. Although in narrative form, the recommendations are fairly clear, unambiguous and likely to be consistent with practice in the UK
with regard to minimal and moderate sedation only.
It would not be appropriate to base recommendations for the UK on this guideline but it might be useful to cite it as verification of recommendations if they are consistent.
SDCEP guidance themes: sedation technique✓, patient selection✓, records✓, consent✓, training✓, monitoring✓, fasting✓, environment✓, equipment✓, staffing✓, patient viewsX
(✓) = mentioned but not in detail.
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Appendix 4 – Evidence Appraisal Forms Guideline G10: AAPD, 2011
Relevant changes
New title: Guideline for Monitoring and Management of Pediatric Patients Before, During and After Sedation for Diagnostic and Therapeutic Procedures
Source: http://www.aapd.org/media/Policies_Guidelines/G_Sedation1.pdf
Updated Aim: The purpose of this updated report is to unify the guidelines for sedation used by medical and dental practitioners; to add clarifications regarding monitoring modalities,
particularly regarding continuous expired carbon dioxide measurement; to provide updated information from the medical and dental literature; and to suggest methods for further
improvement in safety and outcomes.to add clarifications regarding monitoring modalities, particularly regarding continuous expired carbon dioxide measurement; to provide updated
information from the medical and dental literature; and to suggest methods for further improvement in safety and outcomes.
Scope: previously the guideline stated that it applied to children up to age 21 years – not stated in update
Updated recommendations:
On-site monitoring and rescue equipment: the update now provides a list of equipment required and states that emergency life support equipment must allow for life support of the
patient until transported to an emergency facility.
Documentation at the time of sedation: assessment guidance is more extensive in update including more detail on relevant medical history and inclusion of measurement of oxygen
saturation in addition to heart rate, blood pressure, respiratory rate and temperature).
Documentation during treatment: Capnography has been added in update: The patient’s chart shall contain documentation at the time of treatment that the patient’s level of consciousness
and responsiveness, heart rate, blood pressure, respiratory rate, expired carbon dioxide values, and oxygen saturation were monitored. Standard vital signs should be further documented at
appropriate intervals during recovery until the patient attains predetermined discharge criteria.
Continuous quality improvement: Update adds requirement to track significant interventions.
Moderate Sedation: The update provides further details for the practitioner on rescue and indicates that skills reinforcement should include with simulation. The update stipulates that the
support personnel should be trained in advanced airway skills (previously only required paediatric basic life support). Capnography is now recommended for moderate sedation (required
for deep sedation) and monitoring parameters should be recorded every 10 minutes.
Deep Sedation: The update provides further details, but this is not included in the scope of the SDCEP guidance.
Appraisal
As for the 2011 version, the 2016 update does not describe the methodology used and there is no discussion of barriers, implementation or patient views. Almost 500 references are cited
for the update but there is no description of how the search was carried out or any discussion of the evidence quality. The recommendations are presented in a similar way to the 2011
version. As a result, the 2016 update would also rate, using the AGREE II tool, as 2/7 (Low quality).
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Appendix 4 – Evidence Appraisal Forms Guideline G12: Glassman et al., 2009
• Includes a description of the modalities listed below that can be used to help individuals with special needs receive dental treatment services, with a discussion of the advantages and
disadvantages of each modality. Also included is information about combinations of modalities and frequency of administration. The definitions for anesthesia and sedation used here
are from the American Dental Association's Guidelines for the Use of Sedation and General Anesthesia by Dentists
General anesthesia delivered in hospitals, surgical centers, and dental offices
Sedation—ranging from minimal sedation to deep sedation
Behavioral support
Physical support
Psychological support
Social support
Prevention strategies
• Describes levels of sedation. Although cognitive function and coordination may be modestly impaired, ventilatory and cardiovascular functions are unaffected. A more thorough
description and comparison of various techniques for delivering sedation are contained in other articles. As with general anesthesia, sedation is generally available for dental treatment
96
Appendix 4 – Evidence Appraisal Forms Guideline G12: Glassman et al., 2009
in hospitals or surgical centers. Dental and other anesthesiologists are available in certain areas to provide sedation in a dental office. In addition, some dentists are trained and
equipped to provide sedation services in their offices in conjunction with dental treatment. Moderate and particularly minimal sedation require less training, less equipment, and less
stringent licensing than deep sedation or general anesthesia and therefore are available in a larger number of dental offices.
• Sedation, particularly moderate and minimal sedation, is easier to arrange and generally less expensive than deep sedation or general anesthesia. This procedure generally has a
lower risk of side effects than do deep sedation or general anesthesia.
• Discusses impact of financing on oral health treatment decisions
• Discusses impact of education on oral health treatment decisions
Geographical setting for guidance: Healthcare setting for guidance: Is guidance currently used?
users and patients
Guidelines developed by an American society Not clearly stated. Most recent therefore likely to be
Patient/Problem: (target patients and actual participant characteristics) Intervention or risk factors: Comparison: Outcomes: note with * those which are
critical/important (from patient perspective)
for the guidance recommendation
1 Individuals with cognitive impairment or emotional conditions who have difficulty Sedation N/A Not identified
understanding what is expected in a dental treatment situation.
2 Patients whose fear about receiving dental treatment prevents them from receiving
the needed treatment.
3 Patients who are unable to sit in a dental chair or remain still enough to have
dental procedures performed.
4 Patients who have extensive dental needs that would require extended dental
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Appendix 4 – Evidence Appraisal Forms Guideline G12: Glassman et al., 2009
Randomisation: is it reported and Blinding: consider whether blinding of patients or assessors would Other limitations: e.g. attrition bias (incomplete accounting of patients and
appropriate? be important for outcomes considered outcome events), reporting bias (selective outcome reporting), surrogate
Not described Not described outcomes(?)
No details provided.
Inconsistency: Refers to unexplained Imprecision (random error): Indirectness: consider i) whether interventions Publication bias:
heterogeneity in results. of interest were compared directly or not; ii) e.g. when intervention is new and not many studies
whether population characteristics or settings available- may be biased for positive results
differ from those of interest
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Appendix 4 – Evidence Appraisal Forms Guideline G12: Glassman et al., 2009
Overall quality of guidance (AGREE II) and explanation: Rating of recommendations: Should the recommendations made be considered for SDCEP
guidance?
Overall quality = 2/7 (low) AGREE appraisals available on request. Due to the poor methodology employed, these recommendations should not be used as the basis
This is a low quality guideline. The methodology used to develop this guideline for making recommendations in SDCEP guidance. However, if SDCEP guidance recommendations
appears to be weak. Recommendations are not easy to find and vague. There is are consistent with these recommendations, this guideline could be cited as such.
some discussion of barriers and implementation.
Reviewer’s comments:
This is a consensus statement from SCDA rather than a guideline as such. Although broad statements are made about preferred approaches to care, these are not recommendations and
there is limited evidence to support them.
The methodology is reported but is generally weak. The recommendations are not particularly obvious and are vague. They may be consistent with practice in the UK with regard to minimal
and moderate sedation only. It would not be appropriate to base recommendations for the UK on this guideline but it might be useful to cite it as verification of recommendations if they
are consistent.
aThis is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the possibility of
upgrading. Not relevant for RCTs where quality starts at high.
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Appendix 4 – Evidence Appraisal Forms Guideline G12: Glassman et al., 2009
SDCEP guidance themes: sedation techniqueX, patient selection✓, recordsX, consentX, trainingX, monitoringX, fastingX, environmentX, equipmentX, staffing(✓,) patient viewsX
(✓) = mentioned but not in detail.
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Appendix 4 – Evidence Appraisal Forms Guideline G13: Hosey, 2002
Notes: The Poswillo Report clearly stated that conscious sedation should involve the administration of a single drug. In the light of the paucity of evidence to the converse, and in the
interest of the safety and well-being of child dental patients, this guideline will apply this principle to children’s dentistry in the UK.
Defines conscious sedation as per GDC.
• Goals of paediatric conscious sedation: promote welfare and safety; facilitate care; behaviour management; promote positive psychological response to treatment; safe discharge
Grade C
• Patient Assessment: to include full medical and dental history. Grade C
• Fitness for CS: ASA1 or II for GDS, CDS, specialist paediatric practice; otherwise hospital. Grade C
• Patient Information and Consent: informed consent essential; explanation of alternatives; written pre- and post-operative instruction in advance. Grade C
• Escort: escort required; qualified member of staff always present; seditionist chaperones at all times. Grade C
• Fasting: Not required for N2O, though might recommend light meal only 2 hrs prior to CS. Other forms of sedation: No solids within 6 hrs; No milk within 4 hours; No clear fluid
within 2 hours. Grade C
• Documentatiuon: must include staff names; treatment plan, consent, radiographs, reason; treatment performed with drug, concentration, dosage, route, duration; monitors used
and readings; time-based record, where appropriate. Grade C
• Staff training: dentists must undergo recognised initial training and regularly update; dental nurse should be appropriately trained, CDSN from NEBDN encouraged. Grade C
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Appendix 4 – Evidence Appraisal Forms Guideline G13: Hosey, 2002
Geographical setting for guidance: Healthcare setting for guidance: Is guidance currently used?
users and patients
Guideline developed for UK specialist societies. GDS, CDS, specialist paediatric practice; Unclear. Not listed on BSPD website. Still available on Royal College FDS
otherwise hospital website.
Patient/Problem: (target patients and Intervention or risk Comparison: Outcomes: note with * those which are critical/important (from patient
actual participant characteristics) factors: perspective) for the guidance recommendation
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Appendix 4 – Evidence Appraisal Forms Guideline G13: Hosey, 2002
Healthy anxious children; discussion of the Sedation N/A Not explicitly discussed.
sedation of medically compromised
children or those with a learning disability
is not included.
Randomisation: is it reported and Blinding: consider whether blinding of patients or assessors Other limitations: e.g. attrition bias (incomplete accounting of patients and
appropriate? would be important for outcomes considered outcome events), reporting bias (selective outcome reporting), surrogate
Not described Not described outcomes(?)
No details provided.
Inconsistency: Refers to Imprecision (random error): Indirectness: consider i) whether Publication bias:
unexplained heterogeneity in interventions of interest were compared directly e.g. when intervention is new and not many studies
results. or not; ii) whether population characteristics or available- may be biased for positive results
settings differ from those of interest
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Appendix 4 – Evidence Appraisal Forms Guideline G13: Hosey, 2002
Overall quality of guidance (AGREE II) and explanation: Rating of recommendations: Should the recommendations made be considered for
SDCEP guidance?
Overall quality = 4/7 (moderate) AGREE appraisals are available on Recommendations are clear and there is some link with evidence (using the SIGN system of the
request. time). Given that the guideline is from 2002, it could be a useful source to inform current clinical
recommendations, though more up-to-date evidence would be desirable.
Although aspects of the methodology are lacking, this is a relatively well-structured
and well developed guideline that is informed by evidence and has been through a
consensus process to arrive at recommendations that are generally accepted for the
UK.
Reviewer’s comments:
The recommendations in this guideline, though now nearly 15 years old, are still likely to be relevant to current clinical practice. It is not clear if this guideline is still in general use.
SDCEP guidance themes: sedation technique✓, patient selection✓, records✓, consent(✓), training✓, monitoring✓, fasting✓, environment X, equipment✓, staffing✓, patient viewsX
(✓) = mentioned but not in detail.
aThis is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the possibility of
upgrading. Not relevant for RCTs where quality starts at high.
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Guideline G14: Intercollegiate Advisory Committee for Sedation in Dentistry (IACSD), 2015
Introduction defines conscious sedation as per previous documents, with the addition of "patient..is able to both understand and respond to verbal commands either alone or
accompanied by a light tactile stimulus”.
Options for care: It is essential that all options are considered and explained to the patient (and, where appropriate, the carer) before a decision is reached.
• A practitioner must make a careful, thorough assessment of the patient and his or her needs before deciding that the use of conscious sedation is indicated.
• The treatment plan must be agreed with the patient and any carer; ideally, this should be done in advance of the procedure.
• An individual is considered to be a child until puberty is reached. Such patients require a sedation team member with paediatric resuscitation skills.
• Any child under 12 years with complex oral health needs or who cannot be managed with either BM/LA or LA/inhalation sedation OR any young person aged 12-16 years with
complex oral needs or who cannot be managed with either BM/LA or LA/inhalation sedation or LA/midazolam (all routes) should be referred to a team with the skills equivalent to
those expected of a specialist/consultant paediatric dentist and a consultant in anaesthesia competent in sedation for dentistry for assessment and treatment in a facility equivalent
to an NHS Acute Trust in England. This would include care provided by a managed clinical network or a recognised care pathway.
• When referring a patient, clear referrals must be made, the guidance described by the Dental Sedation Teachers Group should be followed and the responsibilities described by the
General Dental Council (GDC) in the UK must be met.
Preparation for sedation: Valid consent is necessary for all patients receiving dental care under conscious sedation and this must be confirmed in writing, as specified in relevant
national legislation.
• Valid consent should be obtained prior to the day of treatment and must also be re-confirmed on the actual day of treatment.
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• Patient information: Written information for adult and child patients, those with parental responsibility, carers and escorts must be supplied. It must include the range of techniques
suitable for the individual and contact details, including for out-of-hours emergency advice and services. Instructions on the practical arrangements pre-and post-op, including
responsibilities of the escort. A separate sheet with escort instructions is required. Additional information is specified to be provided for child patients.
• Fasting: Views for fasting prior to sedation are described without a clear recommendation. However, it is reasonable to interpret from the report that, as recommended in NICE
guidance, fasting is not necessary for conscious sedation as defined for dentistry. Clinicians who choose to sedate patients without fasting should be prepared to justify this choice.
Clinical environment for sedation
The physical environment, supporting facilities and equipment must be appropriate for the delivery of dental care under sedation.
• All centres providing conscious sedation for the delivery of dental care should be inspected to determine that the necessary standards are in place
• The correct equipment must be available in treatment and recovery areas, and be proper maintenance documented for inspection.
• There must be access for emergency services and patient transfer.
Nature of the clinical team for sedation
All members of the care team must have the relevant knowledge and skills for the technique being used, as defined by their scope of practice and competencies.
• Clinical skills are underpinned by validated education and training while knowledge and continuing competence must be maintained through appropriate continuing professional
development.
• The clinical team required for each technique are described in detail, including level of education and training, necessary life support skills
Techniques for sedation
The selection of a technique must be appropriate for the individual patient and not chosen simply for operator or sedationist convenience or at the insistence of a third party. The
practitioner providing the sedation must be trained and competent in the technique used, and each individual in the team caring for the patient must also have the necessary validated
skills.
• Essential principles include: The simplest and safest technique that is likely to be effective should be used. Titrating a drug/drugs to effect is critical to safely achieving a recognised
sedation endpoint. As a general rule, single drugs are easier to titrate to effect and safer than sequential administration of two or more drugs. Specific considerations that limit the
use of multiple/anaesthetic drug techniques.
• Specific sedation techniques: For all conscious sedation techniques other than inhalation sedation with nitrous oxide/oxygen, competence in cannulation is mandatory.
Standard techniques
• Oral sedation must only be administered in the place where the dental treatment is provided and must only be carried out by practitioners who are already competent in
intravenous sedation. Midazolam is now considered the first choice agent for oral sedation. Oral techniques are not titratable and should only be used when titratable sedation
techniques are inappropriate.
• Inhalation sedation: a titrated dose of nitrous oxide in oxygen is the first choice inhalation sedation technique.
• Intravenous sedation: a titrated intravenous dose of midazolam is usually the first choice intravenous sedation technique.
• Intranasal sedation: e.g. Midazolam, these techniques are not titratable and should only be used when titratable sedation techniques are inappropriate.
Advanced techniques
• Intravenous sedation: opioid (usually fentanyl) and midazolam; ketamine. Midazolam and propofol requires a dedicated sedationist
• Patient controlled sedation: midazolam, propofol.
• Targeted-controlled infusion sedation: propofol. These techniques require the presence of a dedicated sedationist.
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Geographical setting for guidance: Healthcare setting for guidance: Is guidance currently used?
users and patients
Report is developed for UK. The standards apply to all who practise Yes.
conscious sedation techniques, whether
they are dentists, doctors, nurses or
dental care professionals.
Patient/Problem: (target patients and actual participant Intervention or risk factors: Comparison: Outcomes: note with * those which are critical/important
characteristics) (from patient perspective) for the guidance recommendation
Implied from listed issues to consider: anxiety, a Sedation N/A Not explicitly stated.
pronounced gag reflex, a traumatic procedure, the level of
patient co-operation, the nature of the clinical care
required and the time needed to deliver treatment.
The use of conscious sedation may be indicated for
special care patients, certain medical indications or
difficult clinical situations.
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Risk of bias/systematic error (study limitations that could cause systematic error): consider risk of bias for each important outcome
Randomisation: is it reported and Blinding: consider whether blinding of patients or assessors Other limitations: e.g. attrition bias (incomplete accounting of patients and
appropriate? would be important for outcomes considered outcome events), reporting bias (selective outcome reporting), surrogate
Not described Not described outcomes(?)
No details provided.
Inconsistency: Refers to Imprecision (random error): Indirectness: consider i) whether Publication bias:
unexplained heterogeneity in interventions of interest were compared directly e.g. when intervention is new and not many studies
results. or not; ii) whether population characteristics or available- may be biased for positive results
settings differ from those of interest
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
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Not discussed. States: It is recognised that some of the recommendations of this report Not discussed
will have far-reaching consequences. Implementation may have significant
implications for providers and for those who commission dental clinical
services but safety of patients is our priority.
Overall quality of guidance (AGREE II) and explanation: Rating of recommendations: Should the recommendations made be considered for
SDCEP guidance?
Overall quality = 3/7 (low) AGREE appraisals are available on request. The presentation of recommendations does not follow a consistent, clear format and the
This is a recent report of an expert working group convened on behalf of the Royal rationale for recommendations is not presented. It is unclear to what extent evidence, the
Colleges and therefore should be an authoritative source to inform guidance balance of risks and benefits, the practicalities, and practitioner perspectives or patient values
recommendations. Although titled at Standards, the report describes the content as have been taken into account. While some recommendations are clear and unambiguous,
recommendations (e.g. on p3) and as guidance (p87). Consequently, it can be regarded others are much less so and open to alternative interpretation which may or may not have
as a guideline for the purposes of appraisal. been intended. IACSD have provided some further information on certain points in the form
of “Frequently Asked Questions” via their web page.
The structure of the document does not make for easy reading. Recommendations are
embedded within narrative, sometimes in several sections, and so can be difficult to Further clarification of many of the recommendations in this report will be necessary to
identify. The methodology used is apparently weak (not reported) with no discussion of determine how these should be reflected within the SDCEP guidance.
the evidence base, assessment of quality or the basis of recommendations.
Reviewer’s comments:
This report has been available since April 2015. There is comprehensive coverage of conscious sedation issues and it is likely that some practitioners will be adapting their practice
towards complying with this report, which may include ceasing sedation provision. Although the far-reaching implications of the recommendations are recognised in the report, little by
way of advice and/or tools is provided to support putting the recommendations into practice.
Additional information:
The IACSD provides guidance and standards for members of its contributing Royal Colleges that may also be relevant to others. As a recent authoritative source, this report should be
important in informing current and future practice. Several factors have contributed to potential end-users having difficulties implementing the recommendations in this report. These
include: lack of clarity in the text leading to doubt or misinterpretation (it has been necessary for the IACSD to provide answers to numerous FAQs online as a means of addressing this);
unexplained underlying methodology; the absence, before publication, of wide consultation or engagement with stakeholders responsible for the organisation and delivery of care.
Implementation of new standards would ideally involve an associated impact assessment and implementation plan in each of the UK nations.
SDCEP guidance themes: sedation technique✓, patient selection✓, records✓, consent✓, training✓, monitoring✓, fasting✓, environment✓, equipment✓, staffing✓, patient viewsX
(✓) = mentioned but not in detail.
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Guideline G15: National Institute for Health and Care Excellence (NICE), 2010
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Recommendation 35 For a child or young person who cannot tolerate a dental procedure with local anaesthesia alone, to achieve conscious sedation consider:
- nitrous oxide (in oxygen) or
- midazolam.
If these sedation techniques are not suitable or sufficient, refer to a specialist team for an alternative sedation technique.
Geographical setting for guidance: Healthcare setting for guidance: Is guidance currently used?
users and patients
Guidelines developed in UK Hospital settings, including inpatients, outpatients, radiology and Yes
emergency departments. Primary care, including dental and medical
general practice settings.
Infants, children and young people (under 19 years) receiving sedation by
any technique for painful or non-painful diagnostic or therapeutic
procedures including dental surgery and minor operations carried out
under local anaesthesia.
Patient/Problem: (target patients and actual Intervention or risk factors: Comparison: Outcomes: note with * those which are critical/important
participant characteristics) (from patient perspective) for the guidance recommendation
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Infants, children and young people (under 19 Dependent on clinical question Dependent on clinical question Primary outcome:
years) receiving sedation. Successful completion of diagnostic or therapeutic procedure
• measured as the number of patients for whom the
diagnostic or therapeutic procedure was carried out and
completed.
Secondary outcomes:
Behavioural ratings including:
• pain as assessed by the patient or parent or other
observer using validated pain scales e.g. Visual Analogue
Scale (VAS), Children's Hospital of Eastern Ontario Pain
Scale (CHEOPS), Faces Pain Scale (FPS).
• distress and/or anxiety as assessed by the patient or
parent or other observer using validated scales e.g.
Visual Analogue Scale (VAS), Observation Scale of
Behavioral Distress (OSBD).
• patient or parent satisfaction including preference
Sedation timing including
• length of induction: time from administration of sedation
drug to initiation of procedure
• recovery: time from completion of procedure to recovery
criteria being met or recovery to pre-sedation state
• duration of procedure
• total: time from administration of intervention to when
patient has been transferred to the recovery area or has
been discharged
Adverse events:
• Aspiration
• Respiratory intervention, including:
o oral-pharyngeal airway
o endotracheal intubation
o assisted ventilation
• Cardiac arrest requiring either/or:
o external cardiac massage
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o defibrillation
• Oxygen desaturation <90%
• Vomiting
Risk of bias/systematic error (study limitations that could cause systematic error): consider risk of bias for each important outcome
Randomisation: is it reported and appropriate? Blinding: consider whether blinding of patients or assessors would be Other limitations: e.g. attrition bias (incomplete accounting
important for outcomes considered of patients and outcome events), reporting bias (selective
outcome reporting), surrogate outcomes(?)
Described for each RCT in the characteristics of
included studies tables in Appendix D. Described for each RCT in the characteristics of included studies tables in Described for each RCT in the characteristics of included
Appendix D. studies tables in Appendix D.
Risk of bias for each study outcome is recorded in the
evidence profiles for the drugs in section 6 of the full
guideline.
Inconsistency: Refers to unexplained Imprecision (random error): Indirectness: consider i) whether Publication bias:
heterogeneity in results. interventions of interest were compared e.g. when intervention is new and not many studies
directly or not; ii) whether population available- may be biased for positive results
characteristics or settings differ from those
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Appendix 4 – Evidence Appraisal Forms Guideline G15: NICE, 2010
of interest
Risk of bias for each study outcome is Risk of bias for each study outcome is Only some of the evidence relates to Risk of bias for each study outcome is recorded in
recorded in the evidence profiles for the drugs recorded in the evidence profiles for the sedation for dental procedures. the evidence profiles for the drugs in section 6 of
in section 6 of the full guideline. drugs in section 6 of the full guideline. the full guideline.
Meta-analyses for RCTs were performed where drug interventions and comparisons and The outcome data from the studies considered is provided in sections 4 (for fasting and
outcomes were sufficiently homogenous, and studies were combined regardless of dose, psychological preparation) and 6 (for drug efficacy and safety) of the full guideline.
duration of intervention, procedure (within painful and non-painful groups), setting (e.g. The essential evidence from each drug review relevant to dental procedures was extracted and
dentistry, accidents and emergencies) and age. is presented in a summary of evidence for dental procedures (section 6.12.5.1 of full guideline)
Are results for individual studies shown? yes – the primary outcome for this was completion of procedure.
Was it reasonable to combine study results? sometimes Note. The success rate of nitrous oxide in the paediatric dental setting was reported as only
approximately 50% - may be higher if patients are pre-selected.
Was an appropriate method used?
Is the effect substantiala?
Are reasons for variation in results discussed?
Is there dose-response dataa?
Would confounders affect overall resulta?
Adverse events: Benefit/harm/cost considerations? Values/preferences considerations?
Adverse events were considered in the The benefits (efficacy) and risks (adverse events) are considered for each One of the secondary outcome measures for evidence
secondary outcomes and were a key of the drugs. appraisal was patient or parent satisfaction including
consideration for the recommendations on the Health economic analysis was carried for some of the clinical questions preference.
different drugs. e.g. for dental procedures either nitrous oxide or midazolam were shown Literature regarding parental and children’s desire for
to be the lowest cost sedation techniques (see section 6.12.5.2 of full information was identified and reviewed (section 5 of full
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
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guideline). guideline).
A survey was carried out with 63 child sedation patients at
Alder Hey Children’s NHS Foundation Trust. None were
having sedation for dental treatment.
Overall quality of guidance (AGREE II) and explanation: Rating of recommendations: Should the recommendations made be considered for SDCEP
guidance?
Overall quality = 7/7 (high) AGREE appraisals are available on request. Where evidence was considered it was formally appraised for quality using GRADE:
This is a high quality NICE accredited guideline which meets all of the AGREE The outcomes of interest in each RCT were evaluated using a GRADE evidence profile. It was considered
criteria. The evidence, where available, is systematically identified and that research from non RCT observational studies is subject to the usual limitations of observational work,
appraised according to GRADE. Benefits and harms along with cost analysis including dependence on the quality of medical record documentation and potential for bias secondary to
are taken into consideration when forming the recommendations. non randomisation, and un-blinded participants. In these studies (for adverse events), there were no
The strength of the recommendations is not explicitly stated (i.e. weak or interventions or comparisons but merely data collection of events. The datasets were generally large, and
strong) although the words ‘should’, ‘do not’, ‘consider’, ‘ensure’ etc are used were expected to provide more information on a range of adverse events than the small RCTs available for
to indicate strength. review. Due to these limitations, they were assigned a very low quality rating based on the GRADE scheme.
The recommendations were based on consideration of the body of evidence, where applicable, or on expert
consensus.
The recommendations relevant to dental sedation included in this guideline should be considered for
informing recommendations in the updated SDCEP guidance.
Reviewer’s comments:
The conclusions from the evidence to recommendations section for dental procedures (section 6.12.5.3) are:
Moderate sedation maintaining verbal contact (conscious sedation) with intravenous midazolam, is considered to be effective for selected children and young people who are cooperative,
and younger children who can tolerate a nasal mask can be managed with nitrous oxide.
In the past, if these were not effective, anaesthesia has often been the only alternative. The GDG agreed that additional sedation techniques could be effective for patients who cannot be
managed by midazolam or nitrous oxide. If demand is high, alternative sedation techniques would be necessary. The common concern is that additional sedation drugs, especially in
combination, may not be predictable enough for widespread use. Sevoflurane and propofol for example may only be safe enough for use by specialist sedation teams.
The GDG agreed that there were potential important economic advantages of avoiding hospital based anaesthesia services. Economic modelling showed midazolam or nitrous oxide to be
the lowest cost strategies in suitably selected patients. The training of dental sedation teams was regarded as crucial.
An evidence update was carried out in 2012 which included new evidence relevant to dental sedation. However, the existing recommendations were not changed.
Note that: Midazolam is used in UK clinical practice for sedating children and young people up to the age of 18. At the time of publication (December 2010) midazolam did not have UK
marketing authorisation for oral or buccal administration, or for children younger than 6 months.
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Midazolam did not have UK marketing authorisation for use for procedural sedation in children under 6 months at the time of publication of the Evidence Update (2012). However, the BNFc
includes dosing advice for children from 1 month.
Although the guideline only applies to paediatric patients, the recommendations in some areas are likely to be applicable to all patients. The guideline covers sedation for different types of
procedures, not just dental and the evidence for drug efficacy and safety is combined irrespective of the setting/procedure. However, the dental specific evidence is also summarised in
section 6.12.5.3 Table 1.
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Aim(s) of guidance:
States: The following recommendations are designed to fully endorse and build upon the generic guidance and lay down specific guidance for the practice of Conscious Sedation in the
provision of dental care.
The guidelines aim to promote good clinical practice with the techniques referred to being appropriate for use by an operator-sedationist where the practitioner carrying out the dental
treatment also administers the Conscious Sedation supported at all times by an appropriately trained assistant. Their purpose is to ensure that the various techniques utilised continue to
have a high level of safety and effectiveness. It is hoped that they will assist colleagues to attain and maintain the high clinical standards which all patients rightly expect.
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Geographical setting for guidance: Healthcare setting for guidance: Is guidance currently used?
users and patients
Report is developed for UK. All practitioners providing Conscious Unclear. Only available on website as an archive.
Sedation for the provision of dental
care in general dental practice,
community and hospital settings
Patient/Problem: (target patients and Intervention or risk Comparison: Outcomes: note with * those which are critical/important (from patient perspective)
actual participant characteristics) factors: for the guidance recommendation
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Appropriate study types? Appropriate search terms? Not stated Inclusion criteria:
Appropriate databases? Not stated No description of search or details of study selection from search results provided.
Unpublished studies? Not stated
Follow up of citations? Not stated
Personal contact with experts? Not stated
Risk of bias/systematic error (study limitations that could cause systematic error): consider risk of bias for each important outcome
Randomisation: is it reported Blinding: consider whether blinding of patients or assessors Other limitations: e.g. attrition bias (incomplete accounting of patients and outcome
and appropriate? would be important for outcomes considered events), reporting bias (selective outcome reporting), surrogate outcomes(?)
Not described Not described No details provided.
Inconsistency: Refers to Imprecision (random error): Indirectness: consider i) whether Publication bias:
unexplained heterogeneity in interventions of interest were compared e.g. when intervention is new and not many studies
results. directly or not; ii) whether population available- may be biased for positive results
characteristics or settings differ from those of
interest
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Overall quality of guidance (AGREE II) and explanation: Rating of recommendations: Should the recommendations made be considered for SDCEP
guidance?
Overall quality = 3/7 (low) AGREE appraisals available on request. There is comprehensive coverage of conscious sedation issues and this report has been the basis for
The methodology is weak (or not reported) with unclear stakeholder practice for many years in the UK.
involvement, a lack of systematic searching and appraisal of evidence or use in
informing recommendations, no discussion of barriers or implementation and
unclear editorial independence.
Recommendations are clear and easily found.
Reviewer’s comments:
SDCEP guidance themes: sedation technique✓, patient selection✓, records✓, consent✓, training✓, monitoring✓, fasting✓, environmentX, equipment✓, staffing✓, patient viewsX
(✓) = mentioned but not in detail.
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
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• Staffing: These guidelines are only dealing with conscious sedation. This implies that the dentist should be able to act as his/her own sedationist without the presence of an
anaesthesiologist, provided that these guidelines are followed.
• Patient assessment must include a full medical and dental history as well as a social history.
Each patient must be classified according to the ASA Physical Status Classification System (6). Patients who are ASA Class I or Class II may be considered candidates for conscious
sedation as outpatients. Patients in ASA Class III and Class IV represents special problems and require individual consideration and shall be treated in a hospital environment,
involving the assistance of medical doctors when appropriate.
• Indications and contraindications
When identifying children in need of conscious sedation it is useful to make a combined judgement of the following two groups of factors.
Children with low coping ability: Behaviour management problems; Dental fear and anxiety; odontophobia; Mental retardation; General disorders, psychiatric conditions; Treatment
need: Emergency treatment; Moderate to large and complicated treatment needs.
• Patient monitoring Paediatric dental patients under conscious sedation must be monitored continuously clinically, as this is the most important element in patient monitoring.
Clinical monitoring includes: Response by the patient to physical stimulation and verbal command, Observing breathing, Movements of the thorax, Passage of the air stream,
Respiratory frequency, Observing skin colour. The use of pulse oximetry has been widely discussed. In the case of conscious sedation, oxygen desaturation (i.e. below 95%) is
probably rare. Pulsoximetry is not deemed required for conscious sedation with nitrous oxide/oxygen sedation, but is preferable in benzodiazepine sedation. It is however vital that
the staff are adequately trained in the use of clinical monitoring, and if used the management of electronic monitoring. When pulse oximetry is used, more that 3 out of four of the
alarms may be false positives due to movement artefacts, sensor displacement or other reasons. Young children especially may react with increased anxiety to the placement of the
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pulsoximeter.
• Patient information - Written and oral information, consent, escort
Pre- and postoperative instructions in writing must be given in advance of the procedure to the child and the parent or guardian. Informed consent shall follow the legislation of
the country. An adult who is well known to the child should always escort them to and from treatment. In the context of school dental clinics and the use of nitrous oxide/oxygen
sedation, schoolchildren can after parents’ consent get treatment without the presents of an adult escort, provided the parents have consented.
• Fasting rules vary slightly between the European countries. Prior to conscious sedation it is recommended, that the child shall be fasted according to the following rules: No clear
liquids 2-3 hours before sedation; No solid foods or non-clear liquids 4 hours before sedation. Clear liquids are non-fruity juice, water, tea, and coffee. All milk products (non-clear
liquids) are considered as solid foods. Children under school age shall drink sugar containing clear liquid up to 2 hours before treatment in order to avoid low blood sugar. For the
emergency patient, where proper fasting has not been assured, the increased risk of sedation must be weighed against the benefits of the treatment, and the lightest effective
sedation should be used. If possible, such patients may benefit from delaying the procedure.
• Discharge Before discharge, children should be alert and oriented (or have returned to an age-appropriate base line). A responsible adult must be present to observe the child for
complications after discharge, and to control that the child sits with the head in an upright position to facilitate breathing. In the situation of an outpatient child and if the
responsible adult is driving a car to the home, another adult must be present if the child is young. The adult must be given written and oral instructions on: Appropriate diet,
Medications, Management of possible postoperative bleeding, Level of activity.
• Documentation and records It is recommended that the documentation includes:
Medical history including prescribed medication, Previous dental history, Previous conscious sedations and general anaesthesia, Indication for the use of conscious sedation, Pre-
sedation assessment, Written instructions provided pre- and post-operatively, Presence of an accompanying responsible adult, Arrangements for suitable post-operative
transportation and supervision, Compliance with pre-treatment instructions, The course of the treatment (Monitoring , Dose, and route of administration of sedative drugs, Dental
treatment performed, Sedation evaluation (sedation scale), Accept of sedation and treatment (behavioural scale), Complications), Post-sedation assessment and time of discharge
home
• Safety for the staff Inhalation sedation requires special scavenging equipment to ensure safety for the personal in the operating room. Dental staff must follow strict indications for
the use of nitrous oxide, only use nitrous oxide delivery systems with an efficient scavenging system, have appropriate technique for disconnection of the delivery system, and have
methods for testing the integrity of the breathing system.
• Education and Training: Training of paediatric dentists in sedation should include theoretical training as well as practical training. EAPD Guidelines for postgraduate training in
paediatric dentistry should be followed in developing appropriate training programmes in sedation.
Theoretical training should cover all the subjects referred to in the present document. Practical training should include knowledge of the drugs and equipment used for conscious
sedation, and must be completed before the clinical training. Knowledge of management of complications due to conscious sedation is essential. Training and experience should be
regularly updated and maintained.
Documented, contemporaneous supervised hands-on experience must be acquired for each conscious sedation technique used. The minimum number of documented supervised
cases completed should be no less than those specified by appropriate authorities.
Dental auxiliary personnel assisting during conscious sedation sessions shall also have appropriate but shorter training.
All clinical staff require theory and practical training in basic life support. Basic life support must conform to contemporary guidelines issued by national authorities and dental
associations.
Training can be through informal courses where clinical training is included or in theoretical courses with clinical demonstrations in combinations with clinics where conscious
sedation is regularly performed for hands-on supervision.
Those arranging such training have a duty to ensure that the quality of training and trainers is appropriate and that all theoretical and practical training is documented.
• Drugs used for paediatric dental sedation includes inhalation agents where the gas is delivered through a specially designed machine and the patient inhales the gas through a
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nasal hood (mainly nitrous oxide), benzodiazepines and other agents with sedative properties.
Nitrous oxide when administrated to patients for inhalation must be given in a mixture with oxygen (30% or more) to safeguard the patient’s oxygen supply; has a rapid onset, a
fast recovery (both within minutes) and is a poor anaesthetic.
Benzodiazepines (BZD) are a group of drugs, which have the following effects: anxiolysis, sedation/hypnosis, skeletal muscular relaxation, anterograde amnesia, respiratory
depression and an anticonvulsive effect. A combination of nitrous oxide/oxygen and BZD may be used for conscious sedation, as there is an additive effect of the nitrous oxide to
the BZD sedative effect. In these cases, more strict fasting rules should be followed. Among the different benzodiazepines available, midazolam and diazepam are the most suitable
for use in paediatric dentistry.
Other agents with sedative properties The efficacy of fentanyl and pethidine is questionable and the associated risks may outweigh their benefit and some are only
recommended in some countries for use in hospital settings and by qualified anaesthetists. The use of propofol and ketamine in paediatric dentistry is still experimental and
requires the assistance of or has to be administered by a qualified anaesthesiologist.
• Nitrous oxide/oxygen has been shown to be an effective anxiolytic and sedative inhalation agent for conscious sedation during dental treatment and is recommended as the
preferred drug.
• Indications: Nitrous oxide/oxygen sedation is useful in children 4 years and older and can be used in patients with a strong gagging reflex, which makes dental treatment
impossible, as well as in patients with muscular tone disorders such as cerebral palsy, in order to avoid unintentional movements. Patients belonging to ASA Class III and Class IV
can be treated with the help of nitrous oxide/oxygen sedation provided other indications are present, but treatment of these patients must be restricted to hospital settings, where
an anaesthesiologist can be present.
Contraindications: Pre-co-operative children, Patients with upper airway problems as common cold, tonsillitis or nasal blockage, Patients with sinusitis or recent ENT operations
(within 14 days), Patients in bleomycin chemotherapy, Psychotic patients, Patients with porphyria.
Side effects of nitrous oxide are over sedation, nausea, vomiting, dysphoria, sweating, restlessness, panics, headache, nightmare, tinnitus and urinary incontinence
Delivery The gas mixture shall contain a maximum 50 % nitrous oxide. Nitrous oxide/oxygen sedation and local anaesthesia is an alternative to general anaesthesia. Only dedicated
dental nitrous oxide/oxygen delivery systems must be used. The system must contain fail-safe device (i.e. if the oxygen pressure falls, the supply of nitrous oxide automatically
stops), flow-meter for individual set of gas flow and nitrous oxide concentration, emergency air-valve, non re-breathing, tubes with low breathing resistance, and an effective
scavenging device for exhaled and excess gas. The use of rubber dam improves the effect of the sedation and reduces atmospheric pollution. Dental operators should ensure that
they comply with national guidelines in respect to nitrous oxide pollution and gas safety.
• Midazolam is now the standard BZD agent for conscious sedation during dental treatment in children. After oral administration the peak plasma concentration is reached within 20
minutes, faster via the rectal route in about 10 min. After 45 minutes the sedative effect wears off. The elimination half time is 2 hours, which facilitates a fast recovery.
Indications: see general indications for conscious sedation.
Contraindications: Midazolam must not be given to the following groups of children: under the age of one year; with any form of acute disease; with neuromuscular diseases as
myasthenia gravis; with allergy to BZD; with sleep apnoea; with liver dysfunction; with hepatic dysfunction.
Clinical considerations: All drugs in use in the treatment area must be clearly labelled and each drug should be given according to accepted recommendations.
Routes: Oral midazolam can be administered in tablet form (available in some countries) or as a sweetened mixture for delivery either via a drinking cup or drawn into a needleless
syringe and deposited in the retromolar area. Transmucosal administration of midazolam has the advantage of depositing the drug directly into the systemic circulation. Rectal
sedation utilises this transmucosal approach. Rectal administration requires syringes and a rectal applicator. In some countries, rectal administration is uncommon due to cultural
attitude. Despite this rectal administration of midazolam has a good evidence base. In some countries doctors keep away from rectal administration due to a negative opinion of
the public. Midazolam should be administered at the clinic. Doses provided.
• Diazepam has a long elimination half-life, 24-48 hours, and active metabolites. The clinical action develops within an hour after oral tablet administration. Because of a pronounced
distribution, the time of clinical effect is rather short. Inherited metabolic deficiencies occur in some individuals, with a risk of prolonged effect. Diazepam is highly effective in
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reducing preoperative anxiety, and useful for sleep disturbances prior to treatment.
Routes: Oral administration of tablets can be given either as a single dose 1 hour before treatment, or fractionated, with half the dose taken on the night before, and the remaining
half 1 hour prior to treatment. Tablets can be crushed and mixed in sweetened drink in to facilitate administration. Doses provided.
• Appendices with ASA Classification; Sedation scale according to Wilton.
Geographical setting for guidance: Healthcare setting for guidance: Is guidance currently used?
users and patients
Guidelines developed for use in European countries. Not stated Possibly. Still available on EAPD website, despite being over 10 years since
adopted.
Patient/Problem: (target patients and Intervention or risk Comparison: Outcomes: note with * those which are critical/important (from patient
actual participant characteristics) factors: perspective) for the guidance recommendation
Children: All patients below the age of 18 Sedation N/A Not identified.
years, as defined by the UN Convention on
the Rights of the Child
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Risk of bias/systematic error (study limitations that could cause systematic error): consider risk of bias for each important outcome
Randomisation: is it reported and Blinding: consider whether blinding of patients or assessors Other limitations: e.g. attrition bias (incomplete accounting of patients and
appropriate? would be important for outcomes considered outcome events), reporting bias (selective outcome reporting), surrogate
Not described Not described outcomes(?)
No details provided.
Inconsistency: Refers to Imprecision (random error): Indirectness: consider i) whether Publication bias:
unexplained heterogeneity in interventions of interest were compared directly e.g. when intervention is new and not many studies
results. or not; ii) whether population characteristics or available- may be biased for positive results
settings differ from those of interest
a
This is only relevant for observational studies (automatically start at low quality) where none of the quality criteria need to be downgraded, and allows for the
possibility of upgrading. Not relevant for RCTs where quality starts at high.
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Overall quality of guidance (AGREE II) and explanation: Rating of recommendations: Should the recommendations made be considered for
SDCEP guidance?
Overall quality = 2/7 (low) AGREE appraisals available on request. Recommendations are fairly easy to find and supported by references, although how that was
This is a low quality guideline. Although the recommendations are reasonably clear, identified is not clear. Given that it is from 2003, it could be a useful source to inform current
some are less easy to find and there is no indication that the evidence quality has clinical recommendations, though more up-to-date evidence would be desirable.
been considered. Several aspects of the methodology are lacking.
Reviewer’s comments:
The recommendations in this guideline, though now 13 years old, are still likely to be relevant to current clinical practice. It is not clear if this guideline is still in general use.
SDCEP guidance themes: sedation technique✓, patient selection✓, records✓, consent✓, training✓, monitoring✓, fasting✓, environment X, equipment✓, staffing✓, patient viewsX
(✓) = mentioned but not in detail.
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1. Summary of evidence
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G6: For alternative techniques: The Patient requirements: medical and dental history, age,
ASA, weight, psychological status, social aspects, proposed dental procedure.
Indications for oral and transmucosal sedation with midazolam:
Oral or intranasal sedation should only be used where it is not possible to use one of the
titratable techniques. For example: where intravenous cannulation cannot be achieved due to
patient phobia, learning difficulties or other disabilities; where inhalation sedation with
nitrous oxide does not provide sufficient relaxation or the patient has been assessed as
being too anxious for this to be successful
Contraindications: where it is more appropriate to use one of the titratable techniques (e.g.
intravenous or inhalation sedation). It is thus the third choice technique; where cannulation is
difficult or impossible due to the anatomy of the patient or where there is a history of failed
cannulation (which is not simply the result of patient anxiety); where the sedationist is
inexperienced at cannulation.
G8: Review of patient’s medical history prior to decision to use N2O/O2, including allergies,
medications, diseases etc, previous hospitalization, recent illnesses. Consult medical
specialists for patients with significant underlying medical conditions.
G10: The health evaluation should include: Age and weight. Health history, including: 1)
allergies and previous allergic or adverse drug reactions, 2) medication/drug history,
including dosage, time, route, and site of administration for prescription, over-the-counter,
herbal, or illicit drugs, 3) relevant diseases, physical abnormalities, and neurologic
impairment that might increase the potential for airway obstruction, such as a history of
snoring or obstructive sleep apnea, 4) pregnancy status, 5) a summary of previous relevant
hospitalizations, 6) history of sedation or general anesthesia and any complications or
unexpected responses, and 7) relevant family history, particularly related to anesthesia.
Review of systems with a special focus on abnormalities of cardiac, pulmonary, renal, or
hepatic function that might alter the child’s expected responses to sedating/analgesic
medications. Vital signs, including heart rate, blood pressure, respiratory rate, and
temperature (for some children who are very upset or non-cooperative, this may not be
possible and a note should be written to document this occurrence). Physical examination,
including a focused evaluation of the airway (tonsillar hypertrophy, abnormal anatomy e.g.
mandibular hypoplasia) to determine whether there is an increased risk of airway
obstruction. Physical status evaluation [ASA classification]. Name, address, and telephone
number of the child’s medical home.
G12: lists indications for sedation and factors to consider: health history, current medical and
physical status (refers to ASA status), likelihood of success, time and effort required, cost,
risks, social environment and support available, availability of various treatment modalities,
urgency.
G13: Assessment to include full medical and dental history before decision to use sedation
(SIGN Grade C, no references cited)
G14: To facilitate the provision of high quality dental care, conscious sedation is just one
option for the control of anxiety. The decision to use a particular (behaviour management)
approach must be based on a full assessment in respect of healthcare history, psychological
needs and overall management. The use of conscious sedation may be indicated for special
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allergy to BZD; with sleep apnoea; with liver dysfunction; with hepatic dysfunction.
Eleven guidelines methodologically rated high (G15), moderate (G1, G13) or low (G3, G5, G6,
G10, G12, G14, G16, G17) provide recommendations related to factors to be assessed to
determine the suitability for use of sedation, which are based on expert opinion of best
practice. These factors relate to patient-specific factors and indications for sedation. The level
of detail provided about factors that influence the decision to use sedation varies
significantly.
Patient – specific factors. All eleven guidelines recommend assessment of medical history
(some list details) and several specify assessment of the physical condition of the patient (G1,
G6, G10, G12, G16) and cite assessing ASA status, and significant medical conditions (G1, G5,
G8, G10, G15), which might warrant referral to a specialist or secondary care.
A variety of other patient factors are specifically mentioned including: Personal details (G10);
social history (G1, G6, G16), dental history (G6, G13, G16), age (G6, G10), weight (G6, G10,
G15), proposed dental procedure/problem (G6, G16), medication, vital signs (G10, G16),
airway (G1, G5, G10, G15). G12 also lists: likelihood of success, time and effort required, cost,
risks, social environment and support available, availability of various treatment modalities,
urgency.
Indications for sedation.
The highly rated guideline G15 states: Choose the most suitable sedation technique based
on all the following factors: what the procedure involves; target level of sedation;
contraindications; side effects; patient (or parent or carer) preference.
G6 states: Oral or intranasal sedation should only be used where it is not possible to use one
of the titratable techniques.
G12, which is specifically focused on special dental care, lists:
1. Individuals with cognitive impairment or emotional conditions who have difficulty
understanding what is expected in a dental treatment situation.
2. Patients whose fear about receiving dental treatment prevents them from receiving the
needed treatment.
3. Patients who are unable to sit in a dental chair or remain still enough to have dental
procedures performed.
4. Patients who have extensive dental needs that would require extended dental treatment
over a prolonged period of time.
5. Patients who require dental procedures that cannot easily be performed with local
anaesthesia because of an inability to achieve adequate local anaesthesia for that procedure.
6. Individuals with complex medical problems who require intra- and perioperative
monitoring.
7. Individuals with complex medical problems (e.g., severe hypertension and cardiac or
respiratory disease) whose physiologic state will be more safely controlled in a sedated or
anesthetized state.
G14 notes: The use of conscious sedation may be indicated for special care patients, certain
medical indications or difficult clinical situations.
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G17 lists: Children with low coping ability: Behaviour management problems; Dental fear and
anxiety, odontophobia; Mental retardation; General disorders, psychiatric conditions;
Treatment need: Emergency treatment; Moderate to large and complicated treatment need.
Also states: N2O/O2 is useful for children: 4 years and over; with strong gagging reflex; with
muscular tone disorders.
3. Subgroup considerations
It may be difficult to carry out all aspects of a full assessment (e.g. oral examination) for
some patients e.g. young or very anxious children or patients with additional needs.
Adaptation of the process might be required in these cases.
Patients who are not ASA I or II i.e. it is likely that patients that are ASA III or above will not
be treated in a primary care setting.
Patients with significant medical conditions (e.g. cardiovascular, respiratory problems, airway
concerns).
Consider support for children with additional needs to enable sedation in preference to GA
i.e. ways of helping children to cope.
The location of the assessment and treatment facilities may be important for some groups
e.g. those with long travel times.
4. Balance of effects
There is agreement about the importance of thoroughly assessing the patient and the
purpose of the sedation technique being considered, to ensure that the correct decision is
made for the individual patient.
Many of the guidelines cited are from the UK and are generally consistent with those from
other countries. The assessment should be tailored to the individual patient and their needs.
7. Acceptability
It is likely that patients would expect a thorough assessment and a decision about sedation
that is specific to their individual needs.
8. Feasibility
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9. Other factors
The group agreed that ideally assessment should take place on a separate visit prior to
treatment, but acknowledged that there are circumstances in which this might not be
feasible, e.g. urgent care. Also, the location might influence how and where assessment is
carried out.
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The 2016 update of guideline G10 recommends that vital signs measured at assessment
should include oxygen saturation (unless not possible for children who are upset or
noncooperative).
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Question 2.2: For patients undergoing dental treatment under Appraisal refs:
sedation: G14, G15
who should make the assessment and how should this be carried
out and recorded?
1. Summary of evidence
Two guidelines, including the highly rated G15, make recommendations, which are based on
expert opinion of best practice. Terminology differs in G14 and G15.
Is it important to state who makes the assessment of suitability for sedation and if so, what
unambiguous term can be used to specify who this should be?
3. Subgroup considerations
Are there certain patients for whom assessment might be carried out, even in part, by a
different individual (e.g. the need for two visits in remote locations)?
4. Balance of effects
There is a high risk that patient safety and treatment will be compromised if the practitioner
responsible for patient assessment is not one who has the appropriate knowledge and skills
to be able to judge whether and what kind of sedation would be suitable for the patient to
allow the dental treatment required.
Both guidelines cited are from UK. G14 covers all patients, G15 children and young people.
It is likely that patient expectation would be that the assessment would be carried out by
someone with the appropriate training. This was confirmed by a patient representative.
7. Acceptability
It is likely that responsibility for patient assessment for sedation being that of the sedationist
would be the expectation.
8. Feasibility
Again, are there certain patients (e.g. the need for two visits in remote locations) for whom
assessment might be carried out, even in part, by a different individual.
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9. Other factors
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See Question 7.1 for aspects of the assessment to record in the patient’s notes.
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Question 2.3: For patients undergoing dental treatment under Appraisal refs:
sedation: G1, G3, G5, G8, G10,
how should consent be obtained for sedation? G13, G14, G15, G16,
G17
1. Summary of evidence
Ten guidelines methodologically rated high (G15), moderate (G1, G13) or low (G3, G5, G10,
G12, G14, G16, G17), provide recommendations on the obtaining of consent for sedation,
which are based on expert opinion of best practice.
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Seven guidelines state that informed written consent must be obtained (G3, G5, G8, G10,
G13, G15, G17), three that valid written consent must be obtained (G1, G14, G16).
G1, G13 and G14 state that consent should be obtained at an appointment prior to the
procedure and G14 states that this should be reconfirmed on the day of the procedure.
G1 states as part of gaining consent, alternative options and risks, including personal risks
should be discussed. G14 describes other aspects of consent including capacity and consent
on behalf of and by children.
The narrative that accompanies the recommendations in G15 describes the factors to be
discussed with the child or young person and/or their parent guardian when obtaining valid
consent, including involvement of the child in the discussion, choices of sedation techniques
(or no sedation or general anaesthesia) risks, side effects and the patient’s ability to cope
with discomfort or anxiety
G5, G8 and G13 state that consent should be obtained from the responsible person/parent.
3. Subgroup considerations
Special considerations are required for patients who are unable to give consent for their
treatment. The legal position may differ across the UK.
4. Balance of effects
Even if they are unable to give consent legally, it is important, where their level of
understanding allows, to include patients in the discussions about their treatment and to
allow them to confirm that they are content to proceed.
The information provided to inform consent should be appropriate for the patient’s age and
learning ability.
7. Acceptability
8. Feasibility
Obtaining valid consent is standard practice for provision of dental healthcare. Written
consent for sedation is a GDC requirement.
9. Other factors
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1. Summary of evidence
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opinion)
Ensure that the information is appropriate for the developmental stage of the child or young
person and check that the child or young person has understood the information.
Offer parents and carers the opportunity to be present during sedation if appropriate. If a
parent or carer decides to be present, offer them advice about their role during the
procedure. (based on consensus expert opinion)
G16: Patients must receive careful verbal and written instructions regarding conscious
sedation effects and their responsibilities both before and immediately after it. The patient
and escort should be provided with details of postoperative risks, pain control and
management of possible complications. Adequate information regarding aftercare
arrangements and emergency contact must also be provided.
G17: Pre- and postoperative instructions in writing must be given in advance of the
procedure to the child and the parent or guardian.
Ten guidelines rated methodologically high (G15), moderate (G1, G13) and low (G3, G5, G8,
G10, G14, G16, G17) provide recommendations about pre-sedation patient information.
G5 and G13 state that instructions should be written while G10, G14, G15, and G16 state that
pre-operative instructions should be verbal and written.
Instructions should be given to: patient/child (G1, G3, G5, G13, G14, G16),
parent/guardian/care giver (G3, G5, G10, G13, G14, G16), responsible person/escort (G3, G14,
G17). G14 states that the patient must receive a separate sheet describing the responsibilities
of the escort and G1 and G14 state that for children, separate age appropriate information
regarding the sedation procedure should also be provided.
The methodologically highly rated G15 states that pre-operative instructions should be age-
appropriate, checked for understanding and include: proposed sedation technique; the
alternatives to sedation; associated risks and benefits; the procedure; what the child or
young person (and parent/carer, if present) should do and what the healthcare professional
will do; the sensations associated with the procedure (for example, a sharp scratch or
numbness); how to cope with the procedure.
Other recommendations include: the range of techniques, preparation instructions,
behaviour after the procedure, special instructions for post-op transport of children home,
complications procedures, 24-hour contact number.
G14 devotes two sections to patient information and provides several examples of
information for patients.
Also see Questions 6.3 (What aftercare instructions are required) and 7.2 (What information
should be provided to patients/carers/escorts before and after sedation and in what format).
3. Subgroup considerations
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4. Balance of effects
The consensus is that providing patient information is essential. Not providing suitable
information will compromise the validity of consent and risks the patient being unprepared
for their sedation appointment.
There is general agreement that it is essential to provide pre-operative instructions and this
should not present any practical difficulties.
G15 summarises evidence about parental desire for pre-operative information. In one study
96% of parents wished to received comprehensive information concerning their child’s
anaesthetic, including possible complications. In a second study, over 90% of parents
reported that discussion of anaesthetic risks was desirable and understood. In a third study,
87% of parents wanted to know the risk of death after anesthesia, though understandably,
several parents did not want this discussed in front of the child. Finally, in a review of six
studies the authors concluded that parents want detailed information about the specifics of
anaesthetic procedures, risks and personnel roles.
G15 also examined evidence about children’s desire for information. Only one study is
reported in which the vast majority of children (n=143) aged 7-17 years had a desire for
comprehensive information about their surgery, including information about pain and
anaesthesia, procedural information and information about potential complications.
Feedback from the patient & parent scoping interviews carried out by TRiaDS
(www.triads.org.uk) indicates that patients expect to receive information verbally which is
then backed up in a written form consistently using the same terminology. This should
include a description of what being sedated will feel like for the patient and how it is
possible to experience a sense of ‘loss of time’ whilst being sedated. Nervous or anxious
patients often reported finding it difficult to retain verbal information. Some patients asked
that the clinicians be mindful of the fact that although it is routine for them, it could be the
first time for the patient or parent.
Individual patient feedback indicated that too much information can increase anxiety for
some patients.
7. Acceptability
8. Feasibility
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healthcare setting to ensure that it is compatible with available printers and of a suitably
professional quality. Reference to additional information on the internet if desired is a means
of limiting the amount of printed material supplied.
It may be difficult in some cases to ensure that the patient escort receives information in
advance of the sedation appointment, if, for example, they are not present at the assessment
appointment.
9. Other factors
Consideration should be given to when and how instructions are provided, for maximum
effectiveness. For example, if there is a significant period of time between the assessment
and sedation appointments,
Consideration should also be given to what is the appropriate amount and level of patient
information i.e. providing sufficient information without overburdening the patient/carer.
Following recommended use of the patient information examples provided in G14 could
mean that, for example, an adult patient having intravenous sedation is provided with at
least 4 documents.
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The IACSD agreed that the patient information examples contained within their online report
could be made available as word documents to facilitate use.
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Question 2.5: For patients undergoing dental treatment under Appraisal refs:
sedation: G1, G3, G8, G10,
what instructions should patients be given about eating and drinking G13, G14, G15,
before sedation? G16, G17
1. Summary of evidence
G1: As for G14, fasting recommendations that apply to conscious sedation refer to those
stated in NICE guidance for children G15 (see below). For other levels of sedation, the 2-4-6
fasting rule is recommended. As for G14, clinicians who choose to sedate patients without
fasting should be prepared to justify this choice.
G3: Preoperative dietary restrictions must be considered based on the sedative technique
prescribed.
G8: Fasting is not required for patients undergoing nitrous oxide analgesia/anxiolysis,
though only a light meal two hours before may be recommended.
G10: Children receiving sedation for elective procedures should generally follow the same
fasting guidelines as before general anesthesia (because the absolute risk of aspiration
during procedural sedation is not yet known) – details are provided in the guideline (2-4-6
rule); for emergency procedures in children who have not fasted, the risks of sedation and
the possibility of aspiration must be balanced against the benefits of performing the
procedure promptly.
G13: Fasting: Not required for N2O, though might recommend light meal only 2 hrs prior to
conscious sedation. For other forms of sedation: No solids within 6 hrs; No milk within 4
hours; No clear fluid within 2 hours. (SIGN Grade C, no references cited)
G14: Views for fasting prior to sedation are described without a clear recommendation.
However, it may be reasonable to interpret from the report that, as recommended in NICE
guidance (G15), fasting is not necessary for conscious sedation as defined for dentistry (i.e.
where verbal contact will be maintained). Clinicians who choose to sedate patients without
fasting should be prepared to justify this choice.
G15: Before starting sedation, confirm and record the time of last food and fluid intake in
the healthcare record. Fasting is not needed for: minimal sedation; sedation with nitrous
oxide (in oxygen); moderate sedation during which the child or young person will maintain
verbal contact with the healthcare professional (low quality evidence). For an emergency
procedure in a child or young person who has not fasted, base the decision to proceed with
sedation on the urgency of the procedure and the target depth of sedation.
Apply the 2-4-6 fasting rule (2 hours for clear fluids 4 hours for breast milk 6 hours for solids)
for elective procedures using any for deep sedation and moderate sedation during which the
child or young person might not maintain verbal contact with the healthcare professional.
G16: Fasting is not normally required; however, some authorities recommend the same
fasting requirements as for general anaesthesia.
G17: Fasting rules vary slightly between the European countries. Prior to conscious sedation
it is recommended, that the child shall be fasted according to the following rules: No clear
liquids 2-3 hours before sedation; No solid foods or non-clear liquids 4 hours before
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sedation. Clear liquids are non-fruity juice, water, tea, and coffee. All milk products (non-clear
liquids) are considered as solid foods. Children under school age shall drink sugar containing
clear liquid up to 2 hours before treatment in order to avoid low blood sugar. For the
emergency patient, where proper fasting has not been assured, the increased risk of sedation
must be weighted against the benefits of the treatment, and the lightest effective sedation
should be used. If possible, such patients may benefit from delaying the procedure.
SR5: One included study showed that fasting made no difference to overall behaviour. One
included study noted no fasting pre-treatment and no vomiting in either group receiving
midazolam (intramuscular or intranasal).
Nine guidelines rated methodologically high (G15), moderate (G1, G13) and low (G3, G8,
G10, G14, G16, G17) provide recommendations and one systematic review reports studies
that commented on fasting before conscious sedation.
G15 states very clearly that fasting is not needed for sedation with N2O/O2 or for moderate
sedation where the child or young person will maintain verbal contact, i.e. includes conscious
sedation as defined for dentistry. This is based on low quality evidence from one RCT (no
significant difference +/- fasting before dental treatment) and several observational studies
showing no association between vomiting or other adverse events and pre-sedation fasting
time, and a GDG discussion of avoidance of unnecessary fasting where there are no safety
concerns. For other forms of sedation the 2-4-6 fasting rule is recommended.
Three other guidelines state or imply that fasting is not necessary prior to conscious sedation
(G1, G14, G16) and two indicate that fasting is not needed specifically for N2O/O2 sedation
(G8, G13), though both recommend a light meal only before sedation.
The evidence from the studies reported in SR5 is consistent with guideline recommendations
not to fast before conscious sedation for dental treatment.
Two guidelines (G1 and G14) state the need for clinicians to justify their choice to sedate
without fasting.
3. Subgroup considerations
4. Balance of effects
In studies cited in G15 and SR5, no significant adverse effects of not fasting before sedation
were reported.
For conscious sedation where verbal contact is maintained, it is unlikely that protective
reflexes will be lost and therefore the risk of aspiration is low. For some patients, fasting can
have adverse effects.
The balance of risks will change where there is a significant risk of aspiration and it would be
appropriate to consider fasting in these situations.
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A survey of patient attitudes towards fasting prior to intravenous sedation for dental
treatment found that 79% of patients experienced at least one adverse symptom after
fasting, with a quarter indicating that the fasting process made them feel more nervous
about their sedation appointment.23
It was reported in the patient & parent scoping interviews carried out by TRiaDS
(www.triads.org.uk) that avoiding food and drink was more challenging for appointments in
the afternoon especially for children/adults with additional needs.
7. Acceptability
SDCEP guidance has recommended since 2006 that there is no need for patients to fast
before conscious sedation.
8. Feasibility
A requirement for fasting may lead to more cancelled appointments if patients who have
failed to do this cannot be sedated.
9. Other factors
Several of the cited sources state the importance of recording the advice given about fasting
and confirming and recording the last food and fluid intake prior to sedation.
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recorded to ensure that they have complied with the advice to avoid large meals and
alcohol. In addition, recording this information is important for the auditing of fasting/not-
fasting versus outcomes. The group acknowledged that there may be some patients or
circumstances (e.g. where a significant risk of vomiting and/or aspiration) where it would be
appropriate to consider fasting.
The group agreed that, in line with the recommendations made by NICE (G15), which are
quoted by AoMRC (G1) and IACSD (G14), the key recommendation should indicate that for
conscious sedation where verbal contact will be maintained the patient does not need to fast
unless there are specific indications to do so.
Post-consultation revisions:
The key recommendation was revised after further consideration by the GDG, to recommend
that advice should be provided to the patient about whether to fast or not based on an
individual assessment of the patient and the nature of the sedation and dental procedure. As
before the guidance also advises that, for conscious sedation, if there are no indications for
fasting the patient can be advised that they can eat and drink on the day of the
appointment.
The GDG considered that there should be more emphasis on judgement based on individual
patient assessment. This was already the intention of the recommendation in the
consultation draft, which reflected the low quality evidence, although this may not have been
sufficiently clear to users. Hence, the guidance now indicates that the risk of aspiration and
other factors should be assessed in each case and fasting advice provided accordingly. The
advice provided and justification should be recorded. The GDG acknowledged that whether a
patient is advised to fast or not may also be influenced by local policies or patient or clinician
preference. The group agreed that this should be a conditional recommendation. Although it
is supported by evidence, this evidence is limited and of low quality. Not all practitioners or
patients would choose to follow the recommendation given all the available information. The
balance of risks of fasting versus not fasting is dependent on the individual circumstances in
each case and the sedationist should use their clinical judgement to assess these when
advising the patient. The justification for the advice given should be recorded.
Basis for Key Recommendation: Expert opinion; Low quality evidence
The recommendation reflects the importance of making an individual judgement for each
patient as advocated by current guidelines (G1 and G14) and is consistent with the evidence
based recommendations made by NICE (G15). The evidence regarding fasting before dental
sedation is of low quality and, depending on the circumstances, it may or may not be
appropriate for the patient to modify food and drink intake before sedation. Thus, the
principle of basing fasting advice on individual judgement for each patient is informed by
expert opinion, while low quality evidence supports the option of not fasting for conscious
sedation where there are no indications to do so.
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The 2016 update of guideline G3 recommends that for minimal sedation, preoperative
dietary restrictions must be considered based on the sedative technique prescribed, while for
moderate sedation, it is recommended that pre-operative fasting instructions are given,
based on the ASA Summary of Fasting and Pharmacologic Recommendations (i.e. the 2-4-6
rule).
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Question 2.6: For patients undergoing dental treatment under Appraisal refs:
sedation: G1, G3, G10, G13,
what escort arrangements are required? G14, G16, G17
1. Summary of evidence
G1: Patients meeting discharge criteria following sedation who go on to be sent home
should be discharged into the care of a suitable third party. No further details.
G3: Escort mentioned but no details of requirements.
G10: The pediatric patient shall be accompanied to and from the treatment facility by a
parent, legal guardian, or other responsible person. It is preferable to have two or more
adults accompany children who are still in car safety seats if transportation to and from a
treatment facility is provided by one of the adults.
G13: A parent, legal guardian or other responsible adult must accompany the child to and
from the treatment facility. Also a qualified member of staff always to be present; sedationist
chaperoned at all times. (SIGN Grade C, no references cited)
G14: The presence of a suitable third party to take responsibility for the patient at the time
of discharge is an essential requirement for sedation using anything other than inhalation
sedation with nitrous oxide/oxygen in adults. Children under 16 years of age require an
escort for inhalation sedation.
G16: A responsible adult escort must accompany the patient home and assume
responsibility for the rest of the day (Escort may not be required for adult N2O/O2 sedation).
G17: An adult who is well known to the child should always escort them to and from
treatment. In the context of school dental clinics and the use of nitrous oxide/oxygen
sedation schoolchildren can, after parent’s consent, get treatment without the presence of an
adult escort, provided the parents have consented.
Seven guidelines rated methodologically moderate (G1, G13) and low (G3, G10, G14, G16,
G17) provide recommendations about the patient’s escort, a responsible person to
accompany the patient to and from the treatment facility.
G1 and G3 provide little detail.
G14 and G16 indicate that for N2O/O2 inhalation sedation, only children under 16 require to
have an escort. For other sedation techniques, all patients require an escort.
G10, G13 and G17 are specifically about paediatric sedation. G13 states that a qualified
member of staff must always be present and the sedationist chaperoned. For younger
children, G10 suggests that two responsible adults are required if one will be driving the
patient home.
3. Subgroup considerations
Consideration of extra requirements for younger children and for patients only receiving
N2O/O2 sedation.
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4. Balance of effects
There are potential risks if a patient was to leave a facility unaccompanied having received
sedation, due to after-effects. In the case of inhalation sedation with N2O/O2 the risks would
be minimal because of the rapid reversal of its effects.
Several of the cited guidelines are from the UK and so recommendations should be relevant.
None identified.
7. Acceptability
8. Feasibility
Some provision may be required if a patient is unable to identify an escort (e.g. lives alone or
is homeless).
The clinical team will need to be able to assess the suitability of an escort for taking
responsibility for the patient after sedation.
9. Other factors
In some instances, the escort taking the patient home may not be the person responsible for
supervising the patient for the rest of the day (e.g. when returning a resident to a care
facility). Consideration should be given to ensuring that the appropriate escort information is
passed on.
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Question 2.7: For patients undergoing dental treatment under Appraisal refs:
sedation: G1, G5, G6, G8, G10,
what facilities should be available? G14, G16
1. Summary of evidence
G1: Where multiple drug/anaesthetic drug techniques are used, the sedation team
should have immediate access to the same range of skills and facilities as would be
found in an acute NHS Trust, for the prompt recognition and immediate management of
adverse events.
Where anaesthetic drug techniques (with or without opioid) are used, trained personnel
must be immediately available to assist with the resuscitation of a collapsed patient so that
the patient’s airway, breathing and circulation are supported fully without delay.
G5: The procedure must be performed in a location which is of an adequate size, and is
staffed and equipped to deal with a cardiopulmonary emergency. These facilities and
equipment must be sufficient and appropriate for the age and condition of the patient so
that, if required, basic life support may be maintained until more specialised help, equipment
and drugs become available. At a minimum this must include: Adequate room to perform
resuscitation should this prove necessary; Appropriate lighting; An operating table, trolley or
chair which can be tilted head down readily is preferable but not mandatory; An adequate
suction source, catheters and hand piece; A supply of oxygen and suitable devices for the
administration of oxygen to a spontaneously breathing patient; A means of inflating the
lungs with oxygen (for example, a self-inflating bag and mask) together with ready access to
a range of equipment for advanced airway management (for example, masks, oropharyngeal
airways, laryngeal mask airways, laryngoscopes, endotracheal tubes); Appropriate drugs for
cardiopulmonary resuscitation and a range of intravenous equipment and fluids including
drugs for reversal of benzodiazepines and opioids (see appendix 2); A pulse oximeter; A
sphygmomanometer or other device for measuring blood pressure; Ready access to an
electrocardiograph (ECG) and a defibrillator; A means of summoning emergency assistance;
Within the facility there should be access to devices for measuring expired carbon dioxide;
Adequate access throughout the facility to allow the patient to be transported easily and
safely; A clinical emergency response plan to manage potential clinical deterioration.
G6: For alternative sedation techniques: Premises must comply with the standards required
for the practice of dentistry but the following require further consideration: waiting area,
surgery, recovery facilities.
G8: All newly installed facilities for delivering nitrous oxide/oxygen must be checked for
proper gas delivery and fail-safe function prior to use.
G10: The practitioner who uses sedation must have immediately available facilities,
personnel, and equipment to manage emergency and rescue situations. A protocol for
access to back-up emergency services shall be clearly identified, with an outline of the
procedures necessary for immediate use. For nonhospital facilities, a protocol for ready
access to ambulance service and immediate activation of the emergency medical system for
life-threatening complications must be established and maintained.
Newly constructed or reconstructed treatment facilities, especially those with piped-in
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nitrous oxide and oxygen, must have appropriate state or local inspections to certify proper
function of inhalation sedation/analgesia systems before any delivery of patient care.
G14: The physical environment, supporting facilities and equipment must be appropriate for
the delivery of dental care under sedation. All centres providing conscious sedation for the
delivery of dental care should be inspected to determine that the necessary standards are in
place. The correct equipment must be available in treatment and recovery areas, and proper
maintenance documented for inspection. There must be access for emergency services and
patient transfer. Circumstances in which sedation must only be performed in a facility
equivalent to an NHS Trust in England are specified: Any child under 12 years with complex
oral health needs or who cannot be managed with either behavioural management
techniques (BM)/local analgesia (LA) or LA/inhalation sedation OR any young person aged
12-16 years with complex oral needs or who cannot be managed with either BM/LA or
LA/inhalation sedation or LA/midazolam (all routes) OR for any patient where multiple drugs
or anaesthetic drugs are used for conscious sedation.
G16: Unimpeded ambulance access to building; large enough treatment and recovery areas,
operating chair capable of head down tilt position.
Seven guidelines rated methodologically moderate (G1) and low (G5, G6, G8, G10, G14, G16)
provide recommendations about the facilities for sedation. Note there is overlap between
requirements for facilities and equipment (Question 2.8).
G14 states that the physical environment, supporting facilities and equipment must be
appropriate for the delivery of dental care under sedation, with documented maintenance of
the equipment located in treatment and recovery areas, and inspection of facilities. G6 states
that premises must comply with standards required for the practice of dentistry.
Room and access: G5 states the room must be of a size adequate for management of
cardiopulmonary emergencies and specifies adequate lighting, preferably a head-down tilt
chair (also stated in G16), suction, oxygen supply and other equipment that must be
available for managing emergencies/complications. G5, G14 and G16 state that there must
be access for emergency services/ambulance and patient transfer.
G5 and G10 state the need for an emergency response plan/protocol.
G6 emphasises the need for a suitable waiting area and recovery facilities.
G8 and G10 state a requirement for inspection of inhalation sedation equipment, including
piped-in N2O and O2 delivery.
G1 and G14 state that where multiple drugs or anaesthetic drugs are used, there should be
immediate access to the skills and facilities found in an NHS Trust. G14 additionally states
that these skills and facilities are required for:
i) sedation of any child under 12 years with complex oral health needs or who cannot be
managed with either behaviour management (BM)/local analgesia (LA) or LA/inhalation
sedation OR
ii) any young person aged 12-16 years with complex oral needs or who cannot be managed
with either BM/LA or LA/inhalation sedation or LA/midazolam (all routes).
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3. Subgroup considerations
Consideration should be given to whether additional facilities are required for anything other
than standard techniques for children, young people and adults and if so, what these
requirements would be.
4. Balance of effects
The careful consideration of facilities is required to reasonably mitigate the risks associated
with each sedation technique.
7. Acceptability
It would be generally accepted that the facilities should be as required to deliver sedation
safely and to manage any complications. The risks of the procedure(s) for the patients being
treated should dictate the minimum requirements for the facilities.
8. Feasibility
Requirements for facilities might preclude some providers from being able to deliver
sedation for some (or all) patient groups.
9. Other factors
The IACSD provided further explanation of ‘a facility equivalent to an NHS Acute Trust in
England’ as used in their guideline (G14), in the form of a FAQ response:
How can I demonstrate that my practice facilities are equivalent to those of an ‘NHS
Acute Trust in England’ (Options for Care, page 9)?
You must be able to provide evidence that in the event of a patient collapse you have the
knowledge, skills and facilities to offer the same quality of immediate care as would be
expected in an NHS Acute Trust. Evidence might include written protocols for managing
collapse and adverse reactions, the timely transfer of a collapsed patient to a hospital with
appropriate resuscitation facilities and the regular checking of emergency drugs and
equipment. Current immediate life support (see FAQ 16) certificates and records of regular
team-based participation in real-time emergency scenarios would also be appropriate. The
SAAD Safe Sedation Practice Scheme (www.saad.org.uk) covers some of these elements. The
checklist used by SAAD inspectors is available for download and may be used for self-
assessment. It is not the responsibility of IACSD to assess evidence.
www.rcseng.ac.uk/dental-faculties/fds/publications-guidelines/standards-for-conscious-
sedation-in-the-provision-of-dental-care-and-accreditation/faq/.
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Questions 2.8: For patients undergoing dental treatment under Appraisal refs:
sedation: G1, G3, G5, G6, G8,
what equipment should be available (for delivery of sedation, G10, G13, G14, G16,
monitoring and management of complications)? G17
1. Summary of evidence
G1: Staffing and equipment must meet the needs of both the technique (including
monitoring) and its possible complications.
Resuscitation equipment must be checked, maintained and include all the drugs necessary
for life support.
G3: A positive-pressure oxygen delivery system suitable for the patient being treated must
be immediately available.
When inhalation equipment is used, it must have a fail-safe system that is appropriately
checked and calibrated. The equipment must also have either (1) a functioning device that
prohibits the delivery of less than 30% oxygen or (2) an appropriately calibrated and
functioning in-line oxygen analyzer with audible alarm. An appropriate scavenging system
must be available if gases other than oxygen or air are used. The equipment necessary to
establish intravenous access must be available for moderate sedation.
G5: When inhalational agents such as nitrous oxide or methoxyflurane are being used to
provide sedation and/or analgesia, risks of chronic exposure should be considered, and the
following special requirements must be satisfied: There must be the capacity for the
administration of 100 per cent oxygen; Installation and maintenance of any piped gas system
must comply with relevant standards. Servicing of such piped gases must occur on a regular
basis and at least annually; An appropriate method for scavenging of expired gases within
the room must be in use.
When nitrous oxide is used: The patient breathing circuit should be of lightweight
construction, should have a reservoir bag for inspired gases, and must provide low resistance
to normal gas flows; There must be a non-return valve or other mechanism (such as a T-
piece flow connection) to prevent re-breathing; Gas flow rates must be adequate and the
circuit must include an anti-hypoxic device; There must be a low gas flow alarm except when
a demand-flow system is used; When methoxyflurane is used, the facility should have a
guideline for the recognition and emergency management of malignant hyperthermia.
Facilities and equipment must be sufficient and appropriate for the age and condition of the
patient so that, if required, basic life support may be maintained until more specialised help,
equipment and drugs become available. At a minimum this must include: Adequate room to
perform resuscitation should this prove necessary; Appropriate lighting; An operating table,
trolley or chair which can be tilted head down readily is preferable but not mandatory; An
adequate suction source, catheters and hand piece; A supply of oxygen and suitable devices
for the administration of oxygen to a spontaneously breathing patient; A means of inflating
the lungs with oxygen (for example, a self-inflating bag and mask) together with ready
access to a range of equipment for advanced airway management (for example, masks,
oropharyngeal airways, laryngeal mask airways, laryngoscopes, endotracheal tubes);
Appropriate drugs for cardiopulmonary resuscitation and a range of intravenous equipment
and fluids including drugs for reversal of benzodiazepines and opioids (see appendix 2); A
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pulse oximeter; A sphygmomanometer or other device for measuring blood pressure; Ready
access to an electrocardiograph (ECG) and a defibrillator; A means of summoning emergency
assistance; Within the facility there should be access to devices for measuring expired carbon
dioxide; Adequate access throughout the facility to allow the patient to be transported easily
and safely; A clinical emergency response plan to manage potential clinical deterioration.
G6: For alternative techniques: Drugs & equipment should be appropriate for the techniques
utilised. These include those required for: sedation, monitoring, the management of
complications and resuscitation.
G8: Inhalation equipment must have the capacity for delivering 100 percent, and never less
than 30 percent, oxygen concentration at a flow rate appropriate to the child’s size.
Additionally, inhalation equipment must have a fail-safe system that is checked and
calibrated regularly according to the practitioner’s state laws and regulations. Selection of an
appropriately sized nasal hood should be made. The equipment must have an appropriate
scavenging system to minimize room air contamination and occupational risk.
G10: Inhalation sedation/analgesia equipment that delivers nitrous oxide must have the
capacity of delivering 100 percent and never less than 25 percent oxygen concentration at a
flow rate appropriate to the size of the patient. Equipment that delivers variable ratios of
nitrous oxide to oxygen and that has a delivery system that covers the mouth and nose must
be used in conjunction with a calibrated and functional oxygen analyzer. An emergency cart
or kit must be immediately accessible (details provided).
G14: The correct equipment must be available in treatment and recovery areas, and formal
maintenance documented for inspection. All necessary equipment and drugs must be
available to support recovery and to manage any complications that may arise.
G16: For N2O/O2 inhalation sedation: dedicated purpose designed machines incapable of
delivering hypoxic mixture; adequate scavenging. For intravenous sedation: all equipment for
the technique available in the treatment area including antagonist drugs; supplemental O2
immediately available with back-up supply. All equipment must be regularly maintained and
appropriate records kept.
G17: Only dedicated dental nitrous oxide/oxygen delivery systems must be used. The
system must contain fail-safe device (i.e. if the oxygen pressure falls, the supply of nitrous
oxide automatically stops), flow-meter for individual set of gas flow and nitrous oxide
concentration, emergency air-valve, non re-breathing, tubes with low breathing resistance,
and an effective scavenging device for exhaled and excess gas. The use of rubber dam
improves the effect of the sedation and reduces atmospheric pollution. Dental operators
should ensure that they comply with national guidelines in respect to nitrous oxide pollution
and gas safety.
Pulsoximetry is not deemed required for conscious sedation with nitrous oxide/oxygen
sedation, but is preferable in benzodiazepin sedation.
Nine guidelines rated methodologically moderate (G1) and low (G3, G5, G6, G8, G10, G14,
G16, G17) provide recommendations on equipment that should be available. The level of
detail provided varies.
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G1, G6 and G16 state that equipment must be suitable for the technique (sedation and
monitoring) and possible complications. G14 states that the correct equipment must be
available in the treatment and recovery areas and formal maintenance documented for
inspection.
Details of specification for equipment for N2O/O2 inhalation sedation varies but common
items include: cannot deliver a hypoxic mixture (G16) / <30% oxygen (G3, G8) / <25%
oxygen (G10) and capable of delivering 100% oxygen (G3, G5, G8, G10); have a fail-safe
system that is checked and calibrated (G3, G8, G17). There must be adequate scavenging
(G3, G5, G8, G16, G17). Equipment must be maintained and records kept (G5, G16).
For intravenous sedation, G16 states that all equipment for delivery of sedation should be in
the treatment area, including antagonist drugs.
Resuscitation equipment must be available, checked and maintained (G1, G10, G16). G5
provides an extensive list of such equipment and states that equipment should be
appropriate for all ages and conditions of patients being treated. G14 states that all
necessary equipment and drugs must be available to support recovery and to manage any
complications that may arise.
Supplemental oxygen must be available (G3) with back-up supply (G16 for intravenous
sedation).
3. Subgroup considerations
4. Balance of effects
Having the correct equipment available for sedation and for dealing with complications is
essential for the safe provision of sedation.
Several of the guidelines cited are from the UK, although some are from other countries that
may be subject to different regulations regarding equipment.
None identified.
7. Acceptability
Some equipment that could be recommended will not currently be available in all practices.
Cost considerations may affect acceptability.
8. Feasibility
See above.
9. Other factors
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The equipment and drugs required for dealing with medical emergencies in a dental practice
are described in the National Dental Advisory Committee (NDAC)’s Emergency Drugs and
Equipment in Primary Dental Care (2015), SDCEP’s Drug Prescribing in Dentistry (3rd Ed)
guidance and Practice Support Manual and the British National Formulary (BNF).24-27 The
NDAC document also lists additional emergency equipment for sedation practices including
pulse oximeter, blood pressure monitor and nasal cannula set for administering
supplemental oxygen.
The Resuscitation Council (UK) Quality Standards for Primary Dental Care28 state that ‘All
clinical dental areas should have immediate access (within the first minutes of a
cardiorespiratory arrest) to oxygen, resuscitation equipment for airway management including
suction, and an automated external defibrillator (AED).’
The 2016 update of guideline G3 added that there should be documentation of compliance
with manufacturers’ recommended maintenance of equipment and pre-procedural checks of
equipment performed. The update also states that equipment for capnography must be
available for moderate sedation.
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Questions 2.9: For patients undergoing dental treatment under Appraisal refs:
sedation: G1, G3, G5, G6, G8,
what staff are required for each sedation technique? G10, G13, G14, G15,
G17
1. Summary of evidence
G1: It is deemed acceptable in some specialties, e.g. dentistry, that, where conscious
sedation is the target state, a second individual already responsible for monitoring the
patient may assist the operator-sedationist with interruptible ancillary tasks of short duration,
no third person being required.
G3: At least one additional person trained in Basic Life Support for Healthcare Providers
must be present in addition to the dentist.
G5: Except for techniques such as inhaled nitrous oxide, inhaled methoxyflurane or low dose
oral sedation, there must be a minimum of three appropriately trained staff present, the
proceduralist, the practitioner administering sedation and monitoring the patient, and at
least one additional staff member to provide assistance to the proceduralist and/or the
practitioner providing sedation as required.
The assistant to the practitioner administering sedation must be exclusively available to that
practitioner at induction of and emergence from sedation, and during the procedure as
required. If general anaesthesia is intended, and especially in emergency situations where
endotracheal intubation is planned, a person to specifically assist the anaesthetist, or other
trained and credentialed medical practitioner within his/her scope of practice, is required
throughout the procedure (see ANZCA professional document PS08 Recommendations on
the Assistant for the Anaesthetist).
A medical or dental practitioner who is skilled in airway management and cardiopulmonary
resuscitation, relevant to the patient’s age and condition, must be present whenever
procedural sedation and/or analgesia are administered.
In situations other than those when an anaesthetist, or other trained and credentialed
medical practitioner within his/her scope of practice, must be present, administration of
sedation and/or analgesia and monitoring of the patient should be performed by another
practitioner working with the proceduralist and whose training complies with the
requirements outlined in section 13. If such an appropriately trained medical or dental
practitioner is not present solely to administer sedation and/or analgesia and monitor the
patient, there must be another health practitioner present during the procedure, who is
trained in observation and monitoring of sedated patients and in resuscitation. The primary
responsibility of this other practitioner is to monitor the level of consciousness and
cardiorespiratory status of the patient. This practitioner must be immediately available to
manage the patient should there be any need. This person may, if appropriately trained,
administer sedative and/or analgesic drugs under the direct supervision of the proceduralist,
who must have advanced life support skills and training. Propofol, thiopentone and other
anaesthetic agents must not be used in these circumstances. If loss of consciousness, airway
obstruction or cardiorespiratory insufficiency occur at any time, all staff must devote their
entire attention to treating and monitoring the patient until recovery, or until such time as
another medical or dental practitioner becomes available to take responsibility for the
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patient’s care.
G6: For alternative techniques: The Team includes operator/sedationist; dedicated
sedationist; dental care professionals (DCPs); recovery personnel; support staff. Each patient
must be attended by at least two appropriately trained and experienced members of the
conscious sedation team.
A dedicated sedationist is required for the administration of any technique requiring the
continuous IV infusion of a drug or drugs OR when three or more sedative drugs are used in
combination regardless of the route. Operator/sedationist using such techniques MUST be
able to demonstrate appropriate training in the use of the specific method, expertise in its
use and also provide audit records of its safe administration in that clinical setting.
Where a dentist works with a dedicated sedationist either employed by the dentist or
employed by a third party there must be a formal or contractual responsibility for the
treating dentist to clarify the responsibilities and accountability of each member of the
dental team involved with each patient during preparation, sedation, recovery and discharge.
G8: The practitioner who utilizes nitrous oxide/oxygen analgesia/anxiolysis for a pediatric
dental patient shall possess appropriate training and skills and have available the proper
facilities, personnel, and equipment to manage any reasonably foreseeable emergency.
G10: The practitioner who uses sedation must have immediately available facilities,
personnel, and equipment to manage emergency and rescue situations. The use of moderate
sedation shall include provision of a person, in addition to the practitioner, whose
responsibility is to monitor appropriate physiologic parameters and to assist in any
supportive or resuscitation measures, if required. This individual may also be responsible for
assisting with interruptible patient-related tasks of short duration. This individual must be
trained in and capable of providing pediatric basic life support.
G13: It is vital that adequately trained staff and the appropriate monitoring facilities are
available to alert the operator if the patient undergoes desaturation. The sedationist should
be chaperoned at all times by another member of staff. (SIGN Grade C, no references cited)
G14: The sedationist or another appropriate person who has capability within his or her
scope of practice must monitor the patient throughout the procedure and will wish to
confirm at regular intervals that the patient is conscious.
Clinical and electro-mechanical monitoring and contemporaneous recording at appropriate
intervals intra-operatively is recommended for all but N2O/O2 sedation. During recovery, the
patient must be supervised; a trained member of the dental team must be responsible for
the patient and monitor the individual throughout this period.
Basic techniques can be delivered by operator-sedationist. Most advanced techniques
require a dedicated sedationist. What are normally considered to be operator-sedationist
techniques may sometimes be more effective and/or safer when the sedation is provided by
a dedicated sedationist and a separate operator, for example when: the patient is medically
compromised, has a physical disability or is emotionally challenging; either the operator or
the sedationist is relatively inexperienced; the patient has a history of being particularly
difficult to manage; the dental procedure is complex or prolonged; patients are at the
extremes of age.
G15: Ensure that both the following will be available during sedation: a healthcare
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professional and assistant trained (see section on personnel and training) in delivering and
monitoring sedation in children and young people; immediate access to resuscitation and
monitoring equipment (see section on clinical environment and monitoring). (expert opinion)
G17: These guidelines are only dealing with conscious sedation. This implies that the dentist
should be able to act as his/her own sedationist without the presence of an
anaesthesiologist, provided that these guidelines are followed.
Ten guidelines rated methodologically high (G15), moderate (G1, G13) and low (G1, G3, G5,
G6, G8, G10, G14, G17) provide recommendations on staff requirements.
Some guidelines are not specific in indicating the number of staff required, stating that
adequate personnel (or similar) are available to manage emergencies (G5, G8, G13).
Most others recommend that for conscious sedation in dentistry, a suitably trained
operator/sedationist may be assisted by one other member of staff carrying out short,
interruptible, patient-related tasks, who is trained in monitoring of the patient and in
assisting in the event of complications (G1, G3, G14, G15, G17).
Exceptions to this are: G6 states that a dedicated sedationist is required for techniques that
require continuous intravenous infusion or where three of more sedative drugs are used. G14
states that most advanced techniques require a dedicated sedationist. G14 also lists several
circumstances in which it is desirable to have a dedicated sedationist for normally operator-
sedationist techniques. G5 states that for certain techniques including N2O/O2 sedation, a
minimum of three members of staff must be present.
G14 states that clinical and electro-mechanical monitoring and contemporaneous recording
at appropriate intervals intra-operatively is recommended for all but N2O/O2 sedation. It is
unclear if this means that for some techniques a third person is required, depending on the
expected frequency of monitoring.
G14 states that a member of staff capable of monitoring must supervise the patient during
recovery and up until discharge. G13 states that the sedationist should be chaperoned at all
times.
G5 provides an appendix that clearly indicates the staff required in various sedation
scenarios.
3. Subgroup considerations
4. Balance of effects
To ensure patient safety there must be sufficient staff members present who have the correct
skills and knowledge to deliver the sedation, monitor the patient and recognise and manage
complications.
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None identified.
7. Acceptability
See below.
8. Feasibility
Requirements for staffing might preclude some providers from being able to deliver sedation
for some (or all) patient groups.
9. Other factors
It is important to indicate the level of training each member of staff must have to fulfill each
role in order to provide a clear recommendation about staff requirements in various
situations.
A query was raised in regard to the IACSD report (G14) and staffing:
Staff required for each technique:
The report states that ‘There must be a written contemporaneous record of the clinical and
electro-mechanical monitoring of physiological systems required for specific sedation
techniques.’ (p30)
Depending on the extent of this, this might require a third team member.
IACSD representatives confirmed that contemporaneous recording includes recording at the
end of the procedure and therefore a third member of the team is not required for recording
during the procedure.
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The 2016 update of guideline G10 revised the recommendation for support personnel for
moderate sedation to indicate that they should be trained in and capable of providing
advanced airway skills (e.g. PALS), rather than paediatric basic life support as recommended
previously.
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For adult patients undergoing dental treatment under sedation: G1, G6, G14, G15, G16
which is the preferred (i.e. effective and safe) method of sedation SR2, SR9
(including drug and route)?
1. Summary of evidence
G1: No one sedation technique is suitable for all patients or procedures. Adopting the
principle of minimum intervention, the simplest and safest effective technique, based
on patient assessment and clinical need, should be used.
For those patients requiring conscious sedation for dentistry, the majority of procedures can
be undertaken using inhalational sedation (N2O/O2), or sedation using a benzodiazepine
(midazolam) as a single drug. Analgesia for painful procedures is provided by means of
effective local anaesthesia in conjunction with behavioural management strategies.
The use of oral sedation may have a limited role. However, titration to effect with oral dosing
is not possible and bioavailability is variable, resulting in an unpredictable response.
When administering intravenous conscious sedation, the initial drug dose should be
determined by careful pre-assessment of the patient and any relevant history, and this
dose must have taken full effect before any additional dose is given. The use of fixed
doses or boluses is unacceptable. Subsequent doses, if necessary, should be carefully
titrated to achieve the desired effect. Safe sedation demands knowledge of each
drug’s time of onset, peak effect and duration of action. In principle, titrating a drug/
drugs to optimal effect is critical to safely achieving a recognised sedation endpoint,
thereby avoiding inadvertent over-sedation or general anaesthesia.
When the intravenous route is used, secure venous access should be maintained
throughout the procedure and into the recovery period, and specific antagonist drugs
(i.e. naloxone and flumazenil) must be to hand.
For localised procedures, e.g. dental or minor procedures, effective local anaesthetic
techniques must be used, once adequate sedation is achieved.
G6: Standard techniques are: Inhalational sedation using nitrous oxide/oxygen; Intravenous
sedation using midazolam alone; Oral/transmucosal benzodiazepine* provided adequate
competence in intravenous techniques has been demonstrated.
*The transmucosal administration of conscious sedation is regarded by some sedationist as
falling within the category of standard techniques. Nevertheless, it is essential that strict
protocols are in place.
G8, G13: see Section 4 Children
G14: The simplest and safest technique that is likely to be effective should be used. Titrating
a drug/drugs to effect is critical to safely achieving a recognised sedation endpoint. A
titrated dose of nitrous oxide in oxygen is the first choice inhalation sedation technique. A
titrated intravenous dose of midazolam is usually the first choice intravenous sedation
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technique. Oral and intranasal sedation techniques are not titratable and should only be
used when titratable sedation techniques are inappropriate.
The ‘basic’ techniques all have an excellent safety record and are of proven efficacy for a
wide range of patients. The vast majority of patients (probably >95%) may be managed
using one of these simple and cost-effective techniques, which are suitable for use by an
appropriately trained and experienced operator-sedationist.
Also see Section 4 Children
G15: see Section 4 Children
G16: The three standard techniques of inhalation, oral and intravenous sedation employed
in dentistry are effective and adequate for the vast majority of patients. The simplest
technique to match the requirements should be used. The only currently recommended
technique for inhalation sedation is a titrated dose of nitrous oxide with oxygen and it is
absolutely essential to ensure that a hypoxic mixture cannot be administered. The standard
technique for intravenous sedation is the use of a titrated dose of a single drug; for example
the current use of a benzodiazepine.
Also see Section 4 Children
G17: see Section 4 Children
SR2: Moderate quality evidence that midazolam by various routes is effective for use for
anxiety control during third molar extraction and very low quality evidence that adverse
events are not increased. It can also be used with other intravenous drugs to obtain better
sedative effects, but the patient’s respiratory function must be monitored closely, because
multidrug sedation is also more risky. Although all patients were having 3rd molar
extractions, the focus of review was on anxiety therefore likely to be of relevance to wider
range of dental treatments.
Four guidelines rated methodologically moderate (G1) and low (G6, G14, G16) provide
recommendations and two systematic reviews (SR2, SR9) are relevant to the preferred
method for sedation. In addition, 3 guidelines and five systematic reviews specifically relate
to the sedation of children (G8, G13, G15, G17, SR1, SR5, SR6, SR7, SR8) – see Question 4.1.
General recommendations are that the simplest and safest, effective titratable technique is
the preferred option (G1, G14, G16).
N2O/O2 is the preferred inhalation sedation technique (G1, G6, G14, G16).
For intravenous sedation, midazolam alone (G1, G6, G14) or ‘a benzodiazepine’ (G16) are
stated as the preferred option.
Oral sedation is less favoured because of inability to titrate to effect (G1). G6 states that
sedation with oral/transmucosal benzodiazepine requires competence in intravenous
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techniques, while G14 states that for all conscious sedation techniques other than inhalation
sedation with nitrous oxide/oxygen, competence in cannulation is mandatory.
G1 states for intravenous sedation, venous access must be maintained through recovery and
antagonist drugs must be available.
SR2 provides moderate quality evidence supporting that midazolam is effective in alleviating
anxiety. SR9 describes low quality evidence of efficacy to support the use of transmucosal
midazolam in situations where intravenous methods might not be suitable. In both
systematic reviews the quality of evidence on adverse effects for the technique(s) is very low
quality at best.
In addition, 3 guidelines and five systematic reviews specifically relate to the sedation of
children (G8, G13, G15, G17, SR1, SR5, SR6, SR7, SR8) – see Question 4.1. In general, these
guidelines consistently identify nitrous oxide or midazolam as suitable effective and safe
sedation techniques for children. Some recommend that nitrous oxide should be the first
choice, with midazolam indicated for adolescents. The evidence provided in the systematic
reviews supports their use.
3. Subgroup considerations
It may be helpful to specify preferred techniques for any specific patient group (other than
children).
4. Balance of effects
The effectiveness of each sedation technique versus the risk and severity of adverse events is
of key importance in deciding whether to recommend a particular technique. Much of the
evidence regarding these comes from substantial clinical experience over many years rather
than from high quality studies.
The evidence discussed above relates to techniques considered ‘basic’ or ‘standard’ for
adults in the UK and may not be generalisable to children. For information specifically
relating to the choice of techniques for children see Question 4.1.
For practical reasons (e.g. implications for staff, equipment required), some providers of
sedation may have a preference for the techniques they use.
Feedback from the patient & parent scoping interviews carried out by TRiaDS
(www.triads.org.uk) indicates that patients trust their clinician to make the appropriate choice
of sedation on their behalf and often only seek reassurance that the method of sedation
selected will be effective.
See additional information under Question 4.1.
7. Acceptability
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8. Feasibility
There are equipment and training implications for different techniques which could affect the
feasibility of a given recommended technique for some sedation facilities.
9. Other factors
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The use of a standard technique as the first choice where possible is largely informed by the
principle of minimal intervention advocated in recent guidelines and is consistent with
current professional practice. There is also some evidence of varying but overall low quality
that supports the use of midazolam (SR2, SR9) and a significant body of clinical experience in
the use of standard techniques that supports the recommendation to use them. However,
there is a lack of evidence comparing the efficacy and safety of standard versus advanced
techniques to inform the preference for a standard technique as a first choice.
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For patients undergoing dental treatment under sedation: G1, G5, G6, G14, G16
1. Summary of evidence
G1: Multiple drug/anaesthetic drug techniques should only be considered where there is a
clear clinical justification, having excluded simpler techniques.
A small number of patients may require the use of systemic analgesia to facilitate
administration of local anaesthesia, for example, if multi-quadrant dental treatment is
planned. For these patients it may be appropriate to administer a single dose of a short-
acting opioid, e.g. fentanyl, waiting a period of time for it to take full effect and only then
titrating midazolam to effect. Due to the unpredictability of titrating multiple drugs to effect,
the addition of a subsequent dose of opioid should be avoided.
Benzodiazepines may be up to eight times more potent following prior administration of an
opioid and so must be titrated with care.
There should be no reliance on systemic analgesia to undertake the procedure itself. If the
procedure cannot be undertaken satisfactorily with local analgesia it would be appropriate to
abandon the procedure and consider an alternative technique of pain and anxiety
management.
Anaesthetic drugs, e.g. propofol, possess a narrow therapeutic index and reduced margins of
safety, increasing the likelihood of adverse events.
G5: Reliable venous access should be in place for all procedural sedation and/or analgesia
except when low doses of inhaled or oral agents are used. This may not be practical in some
patients receiving non-intravenous sedation (for example, small children, intellectually
disabled patients).
The most common intravenous agents used are benzodiazepines (such as midazolam) for
sedation and opioids (such as fentanyl) for analgesia. Because there is usually synergism
between such drugs, even small doses of these drugs may result in loss of consciousness in
some patients.
Intravenous anaesthetic agents such as propofol must only be used by a second medical or
dental practitioner trained in their use because of the risk of unintentional loss of
consciousness. These agents must not be administered by the proceduralist.
G6: Alternative techniques include: any form of conscious sedation for patients under the
age of 12 years* other than nitrous oxide/oxygen inhalation sedation; benzodiazepine + any
other intravenous agent with sedative effects for example: opioid, propofol, ketamine;
propofol either alone or with any other agent for example: benzodiazepine, opioid, ketamine;
inhalational sedation using any agent other than nitrous oxide/oxygen alone; combined
(non-sequential) routes for example: intravenous + inhalational agent (except for the use of
nitrous oxide / oxygen during cannulation).
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* It is recognised that the physical and mental development of individuals varies and may not
necessarily correlate with the chronological age.
G13: see Section 4 Children
G14: Most advanced techniques require a dedicated sedationist and immediate access to
the equivalent range of skills and facilities to be found in an NHS Acute Trust.
Also see Section 4 Children
G15: see Section 4 Children
G16: Continuous infusion of a drug or drugs used in combination may be appropriate in
specially selected circumstances. However, it is particularly emphasised that their
administration must be restricted to an experienced practitioner and team fully trained in
their use working in an appropriate environment.
Also see Section 4 Children
Five guidelines rated methodologically moderate (G1) and low (G5, G6, G14, G16) provide
recommendations relating to acceptable alternative (advanced) forms of sedation.
G6 identifies the range of alternative techniques using drugs including opioids (such as
fentanyl), alone or in combination with a benzodiazepine (e.g. midazolam) and anaesthetic
drugs (e.g. propofol). G14 states that most advanced techniques require a dedicated
sedationist and immediate access to the equivalent range of skills and facilities in an acute
NHS Trust, while G16 states that advanced techniques must only be carried out by a fully
trained and experienced practitioner and team working in an appropriate environment.
In addition, 4 guidelines specifically relate to alternative forms of sedation for children (G13,
G14, G15, G16). – see Question 4.2. Collectively, alternative techniques for children are only
indicated in a minority of cases and require additional skills, experience and facilities.
3. Subgroup considerations
G1 mentions the type of patients/conditions that might merit the use of alternative
techniques. It may be helpful to include this type of guidance.
Some patient groups might require a dedicated sedationist.
4. Balance of effects
The effectiveness of each sedation technique and the risk and severity of adverse events are
of key importance in deciding whether to recommend a particular technique. There is a lack
of research evidence to inform the choice of advanced technique for an individual patient.
Feedback from the patient & parent scoping interviews carried out by TRiaDS
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(www.triads.org.uk) suggests that patients want to have the sedation that they believe will
minimise their anxiety, nervousness and fears.
7. Acceptability
The alternative techniques considered are already used in sedation practice in some parts of
the UK.
8. Feasibility
There are equipment, facility, staffing and training implications for different techniques which
could affect the feasibility of a given recommended technique for some sedation facilities.
9. Other factors
IACSD indicate in their report (G14) that where multiple drugs or anaesthetic drugs are used
the sedation team must have immediate access to the equivalent range of skills and facilities
to be found in an NHS Acute Trust. Further information about this is provided in a response
to a FAQ. See question 2.7 (facilities) for further details.
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For patients undergoing dental treatment under sedation: G1, G3, G5, G14, G16
1. Summary of evidence
G1: Clinical and instrumental monitoring to a degree relevant to the patient’s medical status
and the sedation method, must be used.
For minimal sedation/anxiolysis: dictated by co-morbidity. For conscious sedation: verbal
responsiveness, oxygen saturation, NIBP (use of ECG and ETCO2 are Developmental
Standards).
Existing guidance for patients undergoing anaesthesia identifies the need for pulse oximetry,
ECG and automated non-invasive blood pressure monitoring. If verbal communication is lost
the patient requires the same level of care as for general anaesthesia.
Where conscious sedation is used and continuous verbal contact with the patient
maintained, ECG monitoring is not essential.
Oxygen, via nasal cannulae, should usually be administered from the commencement of
sedation, through to readiness for discharge from recovery, particularly for patients with
relevant medical conditions, where multiple drug techniques or anaesthetic drugs are used,
or deeper levels of sedation administered.
Currently, oxygen administration is not administered in fit patients undergoing brief, simple
procedures and its use in this group should be considered a Developmental Standard.
Where not already in use, as a fundamental standard, capnography for patients receiving
sedation should be considered a Developmental Standard.
Monitoring should be continued into the recovery period.
G3: A qualified dentist administering moderate sedation must remain in the operatory room
to monitor the patient continuously until the patient meets the criteria for recovery. When
active treatment concludes and the patient recovers to a minimally sedated level a qualified
auxiliary may be directed by the dentist to remain with the patient and continue to monitor
them as explained in the guidelines until they are discharged from the facility. The dentist
must not leave the facility until the patient meets the criteria for discharge and is discharged
from the facility.
For minimal sedation, monitoring should include: consciousness, oxygenation, circulation,
ventilation. For moderate sedation, ventilation and pulse oximetry is essential.
G5: Monitoring of the depth of sedation, typically by assessing the patient’s response to
verbal commands or stimulation must be routine. Loss of patient response to stimulation or
verbal commands indicates that loss of airway reflexes, respiratory and/or cardiovascular
depression are likely, and sedation should be lightened accordingly. Monitoring of verbal
response may be difficult in some patients for example, small children, patients with
intellectual disabilities or language difficulties).
All patients undergoing procedural sedation and/or analgesia must be monitored
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continuously with pulse oximetry and this equipment must alarm when appropriate limits are
transgressed. In all patients there must be regular monitoring of pulse rate, oxygen
saturation and blood pressure throughout the procedure. Monitoring prior to
commencement of sedation may not be practical in some patients (for example, small
children, patients with intellectual disabilities). According to the clinical status of the patient,
other monitors such as ECG or capnography may be required
G8, G10, G13: See Section 4 Children
G14: The sedationist or another appropriate person who has capability within his or her
scope of practice must monitor the patient throughout the procedure and will wish to
confirm at regular intervals that the patient is conscious. If this level of sedation is exceeded,
the team caring for the patient must have the appropriate skills to manage the situation.
There must be a written contemporaneous record of the monitoring of the patient that is in
accordance with the clinical sedation technique used. Clinical and instrumental monitoring
relevant to the patient’s medical status and the clinical setting must be used. For inhalation
sedation with nitrous oxide, clinical monitoring will usually suffice. As a minimum for all other
techniques, monitoring should include pulse oximetry as well as non-invasive blood pressure
monitoring preoperatively, at appropriate intervals during the procedure and post-
operatively. All members of the clinical team must be capable of monitoring the condition of
the patient. Monitoring requirements for each technique are tabulated for ASA grade I/II
patients receiving conscious sedation for dental treatment. Clinical monitoring involves
checking the level of consciousness/depth of sedation, airway patency, respiration (rate and
depth), skin colour, capillary refill, pulse rate, rhythm and volume while non-invasive blood
pressure (NIBP) monitoring also records heart rate. NIBP is not essential in children. Intra-
operative measurements may be useful in longer cases. Pulse oximetry provides a visual
display and audible indication of arterial oxygen saturation as well as heart rate and rhythm.
Audible alarms must not be silenced. Routine use of capnography for ASAI and II dental
patients is not recommended.
Also see Section 4 Children
G15: see Section 4 Children
G16: Stringent clinical monitoring and appropriate recording of the level of responsiveness,
airway, respiration, pulse and colour is of particular importance throughout Conscious
Sedation procedures of all types and for each patient. All members of the clinical team must
be capable of monitoring the condition of the patient. For intravenous sedation this must
include the appropriate use of pulse oximetry and blood pressure monitoring. During
inhalation sedation clinical monitoring of the patient without additional electronic devices is
generally adequate.
G17: see Section 4 Children
SR2: For patient safety, continuously monitor the patient’s respiratory function, coupled
with the practitioner’s experience and training, along with the equipment and drugs
necessary to manage this complication. Capnography can provide non-invasive monitoring
of ventilation and detect apnoea during sedation.
Five guidelines rated methodologically moderate (G1) and low (G2, G5, G14, G16) provide
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recommendations relating to monitoring required for sedation and one systematic review
provides comments on monitoring.
In addition, 5 guidelines specifically relate to the monitoring required for sedation of children
(G8, G10, G13, G15, G17) – see Question 4.3 (Section 2).
G1 states that clinical and instrumental monitoring to a degree relevant to the patient’s
medical status and the sedation method, must be used and G14 and G16 state that a written
contemporaneous record of this must be maintained. The sedationist or other suitably
qualified member of the team must monitor the patient throughout the procedure (G5, G14)
but all members of the team must be capable of doing so (G14, G16).
G5 states the requirement for regular monitoring of the depth of sedation, pulse rate,
oxygen saturation and blood pressure throughout the procedure.
G14 and G16 state that for N2O/O2 inhalation sedation, clinical monitoring (details provided
in G14 and G16) is sufficient. For other techniques, the minimum requirement is additionally
pulse oximetry, non-invasive blood pressure (NIBP), before during (at appropriate intervals)
and after the procedure (G14). G14 states NIBP is not essential in children, though it is
unclear which techniques this refers to. G14 states that intra-operative measurements may
be useful in longer cases but it is unclear if this implies it is not useful or necessary in shorter
cases, nor what constitutes a longer case.
Although SR2 suggests that use of capnography might be beneficial, G14 states that it is not
currently recommended for ASAI &II patients. G1 also states that ECG is not essential for
conscious sedation.
3. Subgroup considerations
It is important to make a clear distinction between the extent of monitoring required for
different techniques and patient groups.
4. Balance of effects
Effective monitoring is essential for the recognition of sedation related complications. The
necessity of the type of monitoring should be linked to the risk. For example, it might not be
necessary to monitor blood pressure for patients having inhalation sedation with nitrous
oxide/oxygen, or for children where it might increase anxiety and prevent completion of the
treatment.
Not all forms of monitoring are suitable for all techniques e.g. measuring oxygen saturation
when a patient is receiving nitrous oxide with oxygen is not meaningful.
Although no patient preferences about monitoring were identified, it seems likely that some
patients (e.g. children and patients with additional support needs) may find some forms of
monitoring upsetting.
7. Acceptability
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There could be difficulties with some monitoring of certain patients e.g. before sedation.
8. Feasibility
9. Other factors
G1: Failure to monitor oxygen saturation during sedation is also a ‘never event’ and must be
reported to the National Reporting and Learning System and to the body commissioning this
care.
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The 2016 update of guideline G3 recommends that end-tidal CO2 is measured to monitor
ventilation for patients having moderate sedation.
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1. Summary of evidence
In addition to the information summarised in the tables for Question 3.1 (for all patient
groups) and 4.2 (alternative techniques for children):
G1: Refers to NICE guidance (G15).
G8: Nitrous oxide is generally acceptable to children and can be titrated easily. Most children
are enthusiastic about the administration of nitrous oxide/oxygen.
G13: Inhalation sedation is the recommended route for conscious sedation for paediatric
dentistry. Nitrous oxide inhalation sedation should be offered to children with mild to
moderate anxiety to enable them to accept dental treatment better and to facilitate coping
across sequential visits. (SIGN Grade A, 11 studies cited)
Midazolam is generally reserved for anxious adolescent or adult dental patients. (SIGN Grade
B, no references cited)
G14: The simplest and safest technique that is likely to be effective should be used. For
children under 12 years of age, only nitrous oxide/oxygen is considered to be ‘basic’. The
‘basic’ techniques all have an excellent safety record and are of proven efficacy for a wide
range of patients.
For a young person aged 12-16 years, basic sedation includes nitrous oxide/oxygen
inhalation sedation and midazolam (all routes). Inferred (p27), not stated as such.
G15: Choose the most suitable sedation technique based on all the following factors: what
the procedure involves; target level of sedation; contraindications; side effects; patient (or
parent or carer) preference.
For a child or young person who cannot tolerate a dental procedure with local anaesthesia
alone, to achieve conscious sedation consider: nitrous oxide (in oxygen) or midazolam
(Moderate to very low quality evidence).
G16: Nitrous oxide/oxygen should be the first choice for paediatric dental patients.
G17: Nitrous oxide/oxygen has been shown to be an effective anxiolytic and sedative
inhalation agent for conscious sedation during dental treatment and is recommended as the
preferred drug.
SR1: No randomized controlled trials (RCTs) comparing general anaesthesia (GA) versus
sedation for providing dental care to children were found.
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SR5: There is weak, but consistent evidence from five heterogeneous trials, that following
administration of oral midazolam the behaviour of children was improved relative to
placebo, with variations in the size of the benefit according to the dosage used. Where
reported, adverse effects were few and minor. However, given the small number of studies (n
= 5), participants (n = 182) and high risk of bias for all these papers, this conclusion must
obviously be treated with some caution.
There is very weak evidence from two trials that nitrous oxide inhalation was also more
effective than placebo and no adverse effects were noted. This suggests that this may be an
effective method for managing behaviour in children.
SR6: There is low to very low quality evidence from 7 case series studies that suggests that
inhalation sedation with nitrous oxide can prevent the need for GA in children who would
have otherwise have required it for dental treatment. The proportion of such children may be
between 45 and 64% of all children referred for dental GA. The effectiveness of inhalation
sedation in terms of completing/acceptance of planned treatment could be as high as 83-
97% of selected subgroups of children. Inhalation sedation is suggested to be particularly
suitable for orthodontic treatment for older children and for children requiring no more than
4 extractions, although this is inferred rather than directly addressed by the evidence.
Reported side effects were minor and infrequent.
SR7: Minor side effects associated with IV midazolam usage in children and adolescents
requiring dental treatment have been reported in 19.5% (data from 5 RCTs) and 16.8% (data
from 6 observational studies) of cases with paradoxical reactions being the most common.
No significant side effects were recorded (871 treatments). A subset of the data reports
transient oxygen desaturation at 0% in RCTs and 0.3% of cases in other studies i.e. lower
than for oral route (see SR8 below). This may reflect the ability to titrate via the IV route. The
evidence for these outcomes is judged to be low to very low quality.
SR8: Low to very low quality evidence from 16 RCTs and 11 observational studies suggests
that significant or major side effects associated with oral midazolam usage in children and
adolescents requiring dental treatment are rare (none reported from ~2500 treatments).
Minor adverse events (primarily nausea, vomiting and paradoxical reactions) were more
common (14% of cases in RCTs; 8% of cases in observational studies). Transient desaturation
was reported in 5.6% of cases in the RCTs and 0.2% of cases in the other studies, supporting
the need for adequate monitoring.
Six guidelines with low (G8, G14, G16, G17), moderate (G13) or high (G15) methodological
ratings made recommendations about sedation of children with nitrous oxide or midazolam.
Four of these (G13, G14, G16, G17) indicated that inhalation with nitrous oxide is the
preferred technique for children. Three (G13, G14, G15) provided further recommendations
for midazolam, with G13 and G14 indicating that midazolam may be useful for adolescents
and G15 recommending either technique for a child or young person.
One systematic review (SR5) provides supporting evidence that nitrous oxide is more
effective than placebo and safe, although the evidence quality for this is judged to be very
low. A second (SR6) provides very low quality evidence that nitrous oxide can be effective
and safe for children who were otherwise referred for GA.
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Low quality evidence reviewed in SR5 suggests that oral midazolam is more effective than
placebo and safe. SR7 and SR8 provide low to very low quality evidence that IV and oral
midazolam, respectively, are safe in children.
In general, the guidelines consistently identify nitrous oxide or midazolam as suitable
effective and safe sedation techniques for children. Some recommend that nitrous oxide
should be the first choice, with midazolam indicated for adolescents. The evidence provided
in the systematic reviews supports their use.
3. Subgroup considerations
Sedation by nitrous oxide inhalation is the only technique considered as basic/standard for
children (under 12 years old; G14). All other techniques for this age group would be
considered advanced/alternative. For young people (12-16 years old), any techniques other
than nitrous oxide inhalation or midazolam (by any route) may be considered advanced.
Recommendations made in the guidance about the sedation techniques for children should
reflect the different care options (e.g. required staff, setting, monitoring, life support) that
may result from this distinction.
Consideration should be given to the additional treatment planning skills and experience
that may be required for the management of children with complex oral needs. G14
recommends that skills equivalent to those expected of a specialist/consultant in paediatric
dentistry are available.
4. Balance of effects
The effectiveness of each sedation technique and the risk and severity of adverse events for
each age group are of key importance in deciding whether to recommend a particular
technique.
Although some of the guidelines and studies included in the systematic reviews originated in
other countries, the recommendations and conclusions are consistent with the UK based
articles.
7. Acceptability
8. Feasibility
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Studies have reported that procedures took 3-6 times longer with inhalation sedation than
dental GA (SR6; low to very low quality). Staffing costs for inhalation sedation were estimated
to be cheaper by approximately one-third compared with dental GA (carried out in dental
teaching hospitals). Note however, that although GA may be more expensive than sedation,
treatment completion under sedation may require more visits.
Costs for different techniques:
Health economic analysis suggested that for dental procedures, either nitrous oxide or
midazolam are the lowest cost sedation techniques (G15).
Environment/staff required:
The sedation technique used for a particular age range (i.e. basic versus advanced) may have
implications in terms of staff, setting, monitoring and life support required.
9. Other factors
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equipment and facilities should be appropriate for the patient age and sedation technique.
Basis for Key Recommendation: Expert opinion
This is based on consideration of the importance of both the additional skills required to
manage these patient groups and of an appropriate environment, and is informed by several
recent guidelines.
1. Summary of evidence
G6: Alternative techniques include: any form of conscious sedation for patients under the
age of 12 years other than nitrous oxide/oxygen inhalation sedation. It is recognised that the
physical and mental development of individuals varies and may not necessarily correlate with
the chronological age.
G13: The use of multiple drugs increases the risk of complication and is not recommended.
(SIGN Grade B, 4 studies cited, very low quality)
G14: Any child under 12 years with complex oral health needs or who cannot be managed
with either behaviour management (BM)/Local analgesia(LA) or LA/inhalation sedation OR
any young person aged 12-16 years with complex oral needs or who cannot be managed
with either BM/LA or LA/inhalation sedation or LA/midazolam (all routes) should be referred
to a team with the skills equivalent to those expected of a specialist/consultant paediatric
dentist and a consultant in anaesthesia competent in sedation for dentistry for assessment
and treatment in a facility equivalent to an NHS Acute Trust in England. This would include
care provided by a managed clinical network or a recognised care pathway.
G15: If N2O/O2 inhalation sedation or midazolam sedation techniques are not suitable or
sufficient, refer to a specialist team for an alternative sedation technique (Moderate to very
low quality evidence).
G16: Intravenous sedation for children is only appropriate in a minority of cases. Its use may
be indicated in older children for whom inhalational sedation has been unsuccessful.
Oral/intranasal/transmucosal sedation techniques are not in general use for dentistry at
present. As for adults they should only be administered under appropriate circumstances by
a practitioner experienced in their use.
G17: Midazolam is now the standard BZD agent for conscious sedation during dental
treatment in children
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Six guidelines rated methodologically high (G15), moderate (G13) or low (G6, G14, G16, G17)
provide recommendations about advanced forms of sedation for children.
G6 defines anything other than N2O/O2 inhalation sedation in children under 12 years to be
an advanced technique, as does G14. Additionally, G14 defines anything else other than
midazolam for children 12-16 years to be an advanced technique, and importantly, states
that advanced techniques must be carried out by a team with the skills equivalent to those
expected of a specialist/consultant paediatric dentist and of a consultant anaesthetist in a
facility the equivalent of an NHS Acute Trust in England. G15 states that in such cases, refer
to a specialist team, but does not specify the environment or skills required.
G16 states that intravenous sedation for children is only suited to a minority of cases, e.g.
when inhalation sedation has been unsuccessful, and must be provided by an experienced
practitioner. G13 states that use of multiple drugs in children is not recommended.
Collectively, advanced techniques for children are only indicated in a minority of cases and
require additional skills, experience and facilities.
3. Subgroup considerations
It may be useful to specify indications for the use of advanced sedation techniques for
children (e.g. where nitrous oxide is unlikely to be effective for the patient and treatment
required, or for the avoidance of a general anaesthetic).
4. Balance of effects
The effectiveness of each sedation technique and the risk and severity of adverse events are
of key importance in deciding whether to recommend a particular technique.
Sedation is likely to be preferable for children and parents to GA (see Question 4.1) and
therefore it is important that there is provision for the minority of cases for which advanced
techniques are indicated.
7. Acceptability
8. Feasibility
Being clear about the environment and skills required for the delivery of such techniques,
and alternative ways in which this might be achieved, is important for the planning of
services.
The requirement for specialist skills and facilities is likely to limit the availability of advanced
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sedation techniques for children and might lead to an increased number requiring GA for
dental care.
9. Other factors
IACSD provide further explanation of ‘a team having skills equivalent to those expected of a
specialist/consultant in paediatric dentistry’ and ‘a consultant in anaesthesia competent in
sedation for dentistry’ in responses to FAQs:
How can I show that I have ‘skills equivalent to those expected of a
specialist/consultant in paediatric dentistry’ (Options for Care, page 8)?
You must be able to provide evidence that the person leading the team possesses the
knowledge and skills which will ensure that treatment planning and care under conscious
sedation will be delivered to the same standard as would be expected of a specialist. Evidence
might include training (including CPD, postgraduate qualifications, clinical attachments,
honorary NHS appointments etc.) and documented experience appropriate to the age group/s
to be treated. A good record of experience would include dated (but anonymised) patient data
including age, ASA status, sedation technique, monitoring, dental treatment, recovery,
outcome, adverse incidents and a summary of the number of sedation cases managed per year.
The training and experience of other members of the sedation team, any support available
from a local peer, consultant or MCN and the equipment and facilities available might also be
relevant. The SAAD Safe Sedation Practice Scheme covers some of these elements. The checklist
used by SAAD inspectors is available for download and may be used for self-assessment.
Written support from specialist/consultant who is familiar with your experience might also be
helpful. The syllabuses in Appendix 1 define the knowledge and skills required of the whole
team for a variety of techniques and age groups.
How can I show that I have ‘skills equivalent to those expected of a consultant in
anaesthesia competent in sedation for dentistry’’ (Options for Care, page 8)?
If you are an anaesthetist (i.e. on the GMC Specialist Register in anaesthetics) wishing to
commence providing dental conscious sedation for children and young people you must be
able to demonstrate training and experience in paediatric anaesthesia to a standard equivalent
to that detailed in the paediatric section of the RCoA curriculum and acquisition of the
competencies outlined in the RCoA dental sedation curriculum (IACSD Ref 34).
If you are an anaesthetist already engaged in the provision of dental conscious sedation for
children and young people you must be able to demonstrate that you possess the necessary
competencies for safe independent sedation practice. Formal appraisal/revalidation for this
activity would include demonstration of appropriate paediatric anaesthetic training and
experience, possession of the necessary paediatric dental sedation competencies (IACSD Ref
34), ongoing experience (logbook of sedation activity), evidence of appropriate continuing
professional development, participation in audit of practice and outcomes and documentation
of any complaints.
If you are a medical or dental practitioner you must be able to provide evidence that you
possess the knowledge and skills which will ensure that conscious sedation will be delivered to
the same standard as would be expected of a specialist in anaesthesia (see above) who is
competent in sedation for dentistry. This includes competence in age-appropriate ‘rescue’
procedures in the event of cardio-respiratory complications associated with a deeper level of
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sedation than intended. However, you are not expected to possess broader anaesthetic skills
which are not directly relevant to the administration of dental conscious sedation or its
complications. Evidence might include formal appraisal/revalidation, training (including CPD,
postgraduate qualifications, clinical attachments, honorary NHS appointments etc.) and
documented experience appropriate to the age group/s to be treated. A satisfactory record of
experience would include dated (but anonymised) patient data including age, ASA status,
sedation technique, monitoring, dental treatment, recovery, outcome, adverse incidents and a
summary of the number of sedation cases managed per year. The training and experience of
other members of the sedation team, support available from a local peer, specialist
anaesthetist or MCN and the equipment and facilities available might also be relevant. The
SAAD Safe Sedation Practice Scheme covers some of these elements. The checklist used by
SAAD inspectors is available for download and may be used for self-assessment. Written
support from a specialist anaesthetist who is familiar with your experience might also be
helpful. The syllabuses in Appendix 1 define the knowledge and skills required of the whole
team for a variety of techniques and age groups.
www.rcseng.ac.uk/dental-faculties/fds/publications-guidelines/standards-for-conscious-
sedation-in-the-provision-of-dental-care-and-accreditation/faq/.
There is a lack of reported synthesised evidence on the efficacy and safety of advanced
sedation techniques for children. As for adults, advanced sedation techniques should only be
used for children and young people when standard techniques are not suitable to meet their
clinical needs and would only be appropriate in a minority of cases. Their use must be
justified.
Recommendations and clinical advice:
To be consistent with currently advocated practice (G14), the GDG agreed that the team
responsible for sedating children using an advanced technique (i.e. anything other than
inhalation of nitrous oxide for children and other than nitrous oxide or midazolam for young
people) should include the skills and knowledge equivalent to that expected of a
specialist/consultant in paediatric dentistry. This would also be the case for children and
young people with complex oral health needs irrespective of the sedation technique. These
skills could be from an individual(s) within the immediate team or could be accessed through
wider networks. In either case the aim would be to ensure effective treatment planning for
the patient and to minimize unnecessary repeat sedation episodes. The GDG also agreed
that it would appropriate for the sedationist to have the skills equivalent to those expected
of a consultant in anaesthesia competent in sedation for dentistry delivering advanced
sedation techniques for children and young people.
The facility requirements for any sedation technique are discussed in Question 2.7.
The key recommendation for sedation for children and young people applies to all sedation
techniques (see Question 4.1) and there is no key recommendation specifically for advanced
techniques.
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Post-consultation revisions:
Significant concerns were raised by numerous consultees regarding ‘the skills equivalent to
those expected of a specialist/consultant in paediatric dentistry’. Senior experienced dental
practitioners were unsure about whether and how they could demonstrate these skills.
Furthermore, accessing a specialist/consultant in paediatric dentistry, even via remote
mechanisms, was reported to be currently unworkable in many areas and unlikely to change.
This may be particularly problematic when treating children and young people with complex
oral health needs, because of the level of demand in some settings. These significant
implementation barriers were considered carefully by the GDG and revisions made to this
section of the guidance with the aim of encouraging high quality patient care while
maintaining access to care. In line with the principles put forward in G14, the guidance
upholds the requirement for effective treatment planning for this patient group.
Consequently, the GDG agreed to:
• explain and further emphasise the importance of treatment planning for these patients;
• revise the advice on the management of a child or young person having an advanced
sedation technique, or with complex oral health needs, to focus on the need for effective
treatment planning and the practitioner’s duty to decide if they are competent to do this,
or whether input from a more experienced colleague (likely to be a specialist or
consultant in paediatric dentistry) is required. This is in line with the fundamental
principle that all healthcare professionals should be working within their level of
competency for a particular situation;
• Advocate that teams providing advanced sedation for children and young people work
within a managed clinical network.
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1. Summary of evidence
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G15: For moderate sedation excluding with nitrous oxide alone (in oxygen) continuously
monitor, interpret and respond to changes in all of the following: depth of sedation;
respiration; oxygen saturation; heart rate; pain; coping; distress. (expert opinion)
G17: Paediatric dental patients under conscious sedation must be monitored continuously
clinically, as this is the most important element in patient monitoring. Clinical monitoring
includes: Response by the patient to Physical stimulation and Verbal command, Observing
breathing, Movements of the thorax, Passage of the air stream, Respiratory frequency,
Observing skin colour. The use of pulse oximetry has been widely discussed. In the case of
conscious sedation, oxygen desaturation (i.e. below 95%) is probably rare. Pulse-oximetry is
not deemed required for conscious sedation with nitrous oxide/oxygen sedation, but is
preferable in benzodiazepin sedation. It is however vital that the staff are adequately trained
in the use of clinical monitoring, and if used the management of electronic monitoring.
Six guidelines rated methodologically high (G15), moderate (G13) or low (G8, G10, G14, G17)
provide recommendations on monitoring for sedation specifically of children.
All guidelines agree that clinical monitoring is essential for all forms of sedation. G8, G10 and
G17 provide details.
G10 describes monitoring and recording required before (vital signs), during (sedation
details, O2 saturation, heart rate, and periodically respiratory rate and blood pressure) and
after moderate sedation until discharge criteria are met (vital signs, O2 saturation, heart rate).
Electronic monitoring is not required for N2O/O2 inhalation sedation in children (G13, G15,
G17)
For anything other than N2O/O2inhalation sedation, pulse oximetry is recommended (G13,
G17). G15 recommends continuous monitoring of depth of sedation, respiration, heart rate,
pain, coping and distress. Consistent with this, G14 states that NIBP monitoring is not
essential for children but is unclear about which methods this applies to.
G10 notes that some child patients might require a longer period of observation before
discharge due to potential re-sedation.
3. Subgroup considerations
Some child groups may require additional monitoring e.g. depending on medical status.
4. Balance of effects
Although no patient preferences about monitoring were identified, it seems likely that some
patients (e.g. children and patients with additional support needs) may find some forms of
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monitoring upsetting.
7. Acceptability
8. Feasibility
See above.
9. Other factors
The 2016 update of guideline G10 advises that during moderate sedation, in addition to
continuous monitoring of oxygen saturation and heart rate, monitoring of ventilation by (1)
capnography (preferred) or (2) amplified, audible pretracheal stethoscope (e.g., BluetoothTM
technology) or precordial stethoscope is strongly recommended. If bi-directional verbal
communication is not appropriate or not possible, monitoring of ventilation by capnography
(preferred), amplified, audible pretracheal stethoscope, or precordial stethoscope is required.
The update recommends that these measurements i.e. heart rate, respiratory rate, blood
pressure, oxygen saturation, and expired carbon dioxide values are recorded, at minimum,
every 10 minutes in a time-based record.
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Conscious Sedation for Adults and Children with Special Care Needs (Clinical Questions 5.1-5.3)
Conscious Sedation for Adults and Children with Special Care Needs (Clinical
Questions 5.1-5.3)
Question 5.1: For patients with special care needs that affect Appraisal refs:
provision of their dental care and who are undergoing dental G1, G13, G14, G16,
treatment under sedation: G17
which is the preferred (i.e. effective and safe) method of sedation
(including drug, route)?
1. Summary of evidence
G1: Elderly patients are more sensitive to many drugs than younger patients. It is well
established that the doses of midazolam and opioid they require is usually half or less than
those required for younger patients. Subsequent incremental doses should also be reduced.
It is important therefore to reduce the dose sufficiently in the elderly, frail or at-risk patients.
G13: Those (children) who are not in these categories (ASA I or II) requiring conscious
sedation should be treated in a hospital environment with due consideration to their
individual needs and medical condition, involving the assistance of medical colleagues where
appropriate. (SIGN Grade C, no references cited)
G14: Intranasal (midazolam) sedation is one of a group of routes of administration
referred to as transmucosal sedation. These techniques have become more popular in recent
years, especially in special care dentistry. As with oral sedation, these techniques are not
titratable and should only be used when titratable sedation techniques are inappropriate.
G16: Patients in ASA class III should be referred to an appropriate secondary care unit.
G17: Patients in ASA Class III and Class IV represents special problems and require individual
consideration and shall be treated in a hospital environment, involving the assistance of
medical doctors when appropriate.
Five guidelines of low (G14, G16, G17), moderate (G1, G13) or high methodological quality
(G15) provide recommendations related to the provision of sedation for patients with special
care needs, G1 concerning reducing midazolam or opioid doses for elderly, frail or at risk
patients, and G13, G16 and G17 recommending treatment of ASA III+ patients in a hospital
setting. G14 notes that use of intranasal midazolam should only be considered when
titratable drugs are unsuitable.
Although a guideline specifically about special care dentistry, G12 did not include specific
recommendations about the provision of sedation for patients with special needs.
3. Subgroup considerations
The most appropriate sedation technique to use will depend on the individual needs of any
special care patient e.g. age, physical status, learning ability.
4. Balance of effects
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Conscious Sedation for Adults and Children with Special Care Needs (Clinical Questions 5.1-5.3)
The benefits of each sedation technique considered should be weighed up against the risks
for the individual patient.
The guidelines identified provide recommendations for different special care situations which
would not be applicable in every case.
Feedback from the patient & parent scoping interviews carried out by TRiaDS
(www.triads.org.uk) indicates that patients trust their clinician to make the appropriate choice
of sedation on their behalf and often only seek reassurance that the method of sedation
selected will be effective.
7. Acceptability
Will depend on the sedation techniques recommended for each patient group.
8. Feasibility
See above.
9. Other factors
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Conscious Sedation for Adults and Children with Special Care Needs (Clinical Questions 5.1-5.3)
individual needs. There is some low quality evidence that supports the use of oral or
transmucosal sedation for adults including those with additional support needs (see
Question 3.1). Non-verbal means of communication may be required for some patients.
Post-consultation revisions:
The GDG agreed that further guidance on referral of ASA grade III/IV patients should be
provided. It was considered clear that ASA grade IV patients should only be treated under
sedation in secondary care. There should be more flexibility around where to treat ASA grade
III patients, since this will depend on various factors including the technique used, the
suitability of the environment in terms of skills etc and patient stability. It was agreed that it
was not possible to specify criteria for when to refer ASA grade III patients or what sedation
techniques to provide and that this should be judged by the assessing clinician on an
individual basis. This advice should be provided in the section on assessment.
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Conscious Sedation for Adults and Children with Special Care Needs (Clinical Questions 5.1-5.3)
Question 5.2: For patients with special care needs that affect Appraisal refs:
provision of their dental care and who are undergoing dental
treatment under sedation:
what alternative forms of sedation are acceptable and in what
circumstances (e.g. indications, settings)?
1. Summary of evidence
See Question 5.1, otherwise, none of the included sources has other specific
recommendations on alternative techniques for patients with special needs.
3. Subgroup considerations
See Question 5.1.
4. Balance of effects
See Question 5.1.
7. Acceptability
See Question 5.1.
8. Feasibility
See Question 5.1.
9. Other factors
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Appendix 5 – Considered Judgement Forms
Conscious Sedation for Adults and Children with Special Care Needs (Clinical Questions 5.1-5.3)
patients are to be included in the main sections on sedation techniques for adults or children
and young people.
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Conscious Sedation for Adults and Children with Special Care Needs (Clinical Questions 5.1-5.3)
Question 5.3: For patients with special care needs that affect Appraisal refs:
provision of their dental care and who are undergoing dental G14
treatment under sedation:
what form of monitoring is required for each sedation technique
to reduce the risk of and identify complications?
1. Summary of evidence
3. Subgroup considerations
Some special care patient groups may require additional monitoring e.g. depending on
medical status.
4. Balance of effects
7. Acceptability
8. Feasibility
9. Other factors
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Conscious Sedation for Adults and Children with Special Care Needs (Clinical Questions 5.1-5.3)
with special care needs. Additional monitoring e.g. ECG or capnography may appropriate for
some patients depending on their physical status.
The guidance should note that there may be difficulties in carrying out pre-sedation
monitoring for some patients.
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Appendix 5 – Considered Judgement Forms Recovery and Discharge (Clinical Questions 6.1-6.3)
Question 6.1: For patients undergoing dental treatment under Appraisal refs:
sedation: G1, G3, G5, G10, G14,
when should monitoring stop? G15, G16
1. Summary of evidence
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Appendix 5 – Considered Judgement Forms Recovery and Discharge (Clinical Questions 6.1-6.3)
Guidelines of low (G3, G5, G10, G14, G16), moderate (G1) and high (G15) methodological
ratings provide recommendations relating to the recovery period. Only four (G1, G14, G15,
G16) provide specific details about when it is appropriate to stop monitoring the patient. G1,
G14 and G16 recommend that the patient is monitored throughout recovery. Referring to
children, G15 provides more details indicating that the patient should be monitored until
they have a patent airway; show protective airway and breathing reflexes; are
haemodynamically stable; are easily roused.
Additional points relevant to responsible staff and facilities required for recovery, made by
the other guidelines include that:
• recovery should take place under appropriate supervision in a properly equipped and
staffed area (G5).
• a trained member of the dental team must be responsible for the patient and all
necessary equipment and drugs must be available to support recovery and to manage
any complications that may arise (G14).
• a member of the dental team must supervise and monitor the patient and both
equipment and drugs for dealing with medical emergencies must be immediately to
hand. The practitioner must be available to see the patient urgently in the event of any
problems arising (G15).
• a qualified auxiliary may be directed by the dentist to monitor the patient (during
recovery) until discharge; the dentist must not leave the facility before then (G3).
For information on criteria for indicating when the patient has recovered sufficiently for
discharge, see Question 6.2.
3. Subgroup considerations
Children: prolonged monitoring of recovery might be required if the child has an anatomic
airway problem or a severe underlying medical condition, or if the responsible person has to
drive in addition to observing the child (G10).
Patients who have had a reversal agent: prolonged monitoring of recovery might be required
in case of re-sedation when the effects of the agent wear off (G3, G10).
4. Balance of effects
Appropriate monitoring and care of patients until suitably recovered is an important safety
consideration. Early discharge is likely to carry risk.
It seems likely that the recommendations identified relating to recovery would be generally
applicable, irrespective of their source of origin.
Information on patient preferences about when monitoring should stop was not found.
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Appendix 5 – Considered Judgement Forms Recovery and Discharge (Clinical Questions 6.1-6.3)
However, regarding the recovery period, the preference for a private recovery area, separate
from the incoming patients waiting room, was identified.
7. Acceptability
It seems likely that practitioners and patients would find it acceptable to have monitoring
throughout the recovery period.
8. Feasibility
There could be issues around having sufficient space for a private recovery area if separate
from the treatment area.
Consideration could be given to whether members of the clinical team, other than the
sedationist, could carry out aspects of the discharge process e.g. BP measurement, providing
information, removal of cannula etc, if appropriately trained to do so.
The requirement for monitoring equipment (e.g. for pulse oximetry) in both the treatment
and recovery areas could be a perceived barrier to monitoring during recovery.
9. Other factors
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Appendix 5 – Considered Judgement Forms Recovery and Discharge (Clinical Questions 6.1-6.3)
in G14 were consistent with other guidelines and suitable for use. It was also agreed that the
sedationist would ultimately be responsible for the decision to discharge the patient.
Post-operative instructions are considered in Question 6.3.
The GDG agreed that the key recommendation for recovery and discharge should indicate
that the patient should be monitored throughout the recovery period until discharged into
the care of an escort who has been given post-operative instructions. Further details,
including those described above, will be included in the guidance in the recovery and
discharge section and elsewhere (e.g. monitoring, escort, post-sedation instructions).
Post-consultation revisions:
At consultation, it was noted that (adult) patients having inhalation sedation with nitrous
oxide/oxygen would not usually be discharged into the care of an escort. Consequently, the
key recommendation was amended slightly to indicate that the patient should be monitored
continuously until assessed as fit for discharge. Further advice on escort and post-sedation
instructions will be provided elsewhere in the section on discharge.
Basis for Key Recommendation: Expert opinion
The recommendation is informed by several recent guidelines and is consistent with current
standard professional practice.
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Appendix 5 – Considered Judgement Forms Recovery and Discharge (Clinical Questions 6.1-6.3)
Question 6.2: For patients undergoing dental treatment under Appraisal refs:
sedation: G1, G3, G8, G10, G14,
what discharge criteria are required? G15, G16, G17
1. Summary of evidence
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Appendix 5 – Considered Judgement Forms Recovery and Discharge (Clinical Questions 6.1-6.3)
Guidelines that provide specific details of discharge criteria are G3, G8, G10, G14, G16, G17
(low methodological rating), G1 (moderate) and G15 (high). These criteria are fairly
consistent between the guidelines.
The criteria include:
• The patient has returned to their baseline level of consciousness and responsiveness (G1,
G3, G8, G10, G14, G15, G17)
• Vital signs are within normal limits for that patient (G1, G3, G10, G14, G15)
• Respiratory status is not compromised (G1, G3, G10, G14, G15)
• Pain and discomfort have been addressed (G1, G14, G15)
• The patient can walk unaided (G16) and talk (G10).
• If there is a requirement to discharge the patient prior to meeting these criteria, they
should be transferred to an appropriate clinical environment with continuation of peri-
procedure monitoring standards (G1)
• The cannula, where inserted, has been removed (G14, G16)
• Patients meeting discharge criteria should be discharged into the care of a suitable third
party (G1, G3, G14, G16, G17) to whom written instructions have been provided (G3, G14)
• Verbal and written instructions have been given (G1, G3, G14)
According to G3, G14 and G16 the practitioner/sedationist has the responsibility for
discharge of the patient.
G10 (paediatric) states an additional criterion that the patient’s state of hydration is
adequate. G14 indicates that haemostasis should have been achieved.
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Appendix 5 – Considered Judgement Forms Recovery and Discharge (Clinical Questions 6.1-6.3)
3. Subgroup considerations
See Qu 6.1
4. Balance of effects
Appropriate monitoring and care of patients until suitably recovered is an important safety
consideration. Early discharge is likely to carry risk.
See Qu 6.1
7. Acceptability
It seems likely that practitioners and patients would find the discharge criteria acceptable.
8. Feasibility
See above.
9. Other factors
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Appendix 5 – Considered Judgement Forms Recovery and Discharge (Clinical Questions 6.1-6.3)
Question 6.3: For patients undergoing dental treatment under Appraisal refs:
sedation: G1, G3, G5, G10, G13,
what aftercare instructions are required? G14, G16, G17
1. Summary of evidence
Eight guidelines (methodological rating: low for G3, G5, G10, G14, G16, G17; moderate for
G1, G13) make recommendations on aftercare instructions based on expert opinion of best
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Appendix 5 – Considered Judgement Forms Recovery and Discharge (Clinical Questions 6.1-6.3)
3. Subgroup considerations
4. Balance of effects
The consensus is that providing patient information is essential. Most recommend that this is
both verbal and written. Consideration should be given to when instructions are provided.
Irrespective of the origin of the guidelines, there is general agreement that it is essential to
provide post-operative instructions.
In some instances, the escort taking the patient home may not be the person responsible for
supervising the patient for the rest of the day (e.g. when returning a resident to a care
facility). Patient & parent scoping interviews carried out by TRiaDS (www.triads.org.uk)
indicated that in these circumstances it would be preferable to have written escort
information that could be passed on the next responsible carer. It was also indicated that
escorts would like information about whether the patient should take their prescribed
medications as usual.
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Appendix 5 – Considered Judgement Forms Recovery and Discharge (Clinical Questions 6.1-6.3)
7. Acceptability
It is likely that most patients would find it helpful to receive the appropriate information
about aftercare and that practitioners would find it acceptable to provide post-operative
instructions.
8. Feasibility
9. Other factors
Consideration should be given to what is the appropriate amount and level of patient
information i.e. providing sufficient without overburdening the patients/carer.
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Appendix 5 – Considered Judgement Forms Records and Documentation (Clinical Questions 7.1-7.3)
Question 7.1: For patients undergoing dental treatment under Appraisal refs:
sedation: G1, G3, G5, G6, G8,
what records are required before, during and after treatment G10, G13, G14, G15,
G16, G17
under sedation?
1. Summary of evidence
G1: Patient evaluation, consent, data from monitoring during and after sedation and
readiness for discharge should be documented.
G3: For minimal and moderate sedation: Appropriate time-oriented anesthetic record must
be maintained, including the names of all drugs, dosages and their administration times,
including local anesthetics and monitored physiological parameters. Pulse oximetry and end-
tidal CO2 measurements (if taken), heart rate, respiratory rate and blood pressure must be
recorded continually.
G5: The clinical record should include the names of staff performing sedation and/or
analgesia, with documentation of the history, examination and investigation findings. A
written record of the dosages of drugs and the timing of their administration must be kept
as a part of the patient's records. Such entries should be made as near to the time of
administration of the drugs as possible. This record should also note the regular readings
from the monitored variables, including those in the recovery phase, details of any major
resuscitation or rescue interventions, complications, etc., and should contain other
information as indicated in ANZCA professional document PS06 Recommendations on the
Recording of an Episode of Anaesthesia Care.
G6: For alternative techniques: Documentation and protocols must comply with
contemporary clinical governance standards for the practice of dentistry but the following
require additional consideration: assessment and preparation, written valid consent, technical
procedure and recovery, written instructions for patient and escort.
G8: Informed consent must be obtained from the parent and documented in the patient’s
record prior to administration of nitrous oxide/oxygen.
In addition, the patient’s record should include indication for use of nitrous oxide/oxygen
inhalation, nitrous oxide dosage (i.e. percent nitrous oxide/oxygen and/or flow rate),
duration of the procedure, and post treatment oxygenation procedure.
G10: Before sedation: Documentation shall include, but not be limited to: 1. Informed
consent. 2. Instructions and information provided to the responsible person.
At the time of sedation: Health evaluation (see Question 2.1 Preparation for sedation);
prescriptions for sedation.
During treatment: The patient’s chart shall contain a time-based record that includes the
name, route, site, time, dosage, and patient effect of administered drugs. Before sedation, a
“time out” should be performed to confirm the patient’s name, procedure to be performed,
and site of the procedure. During administration, the inspired concentrations of oxygen and
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inhalation sedation agents and the duration of their administration shall be documented.
Before drug administrations, special attention must be paid to calculation of dosage (i.e.
mg/kg). The patient’s chart shall contain documentation at the time of treatment that the
patient’s level of consciousness and responsiveness, heart rate, blood pressure, respiratory
rate, and oxygen saturation were monitored until the patient attained predetermined
discharge criteria (see Appendix A). A variety of sedation scoring systems are available and
may aid this process. Adverse events and their treatment shall be documented.
After treatment: The time and condition of the child at discharge from the treatment area or
facility shall be documented; this should include documentation that the child’s level of
consciousness and oxygen saturation in room air have returned to a state that is safe for
discharge by recognised criteria. Because some sedation medications are known to have a
long half-life and may delay a patient’s complete return to baseline or pose the risk of
resedation, some patients might benefit from a longer period of less-intense observation
(e.g. a step-down observation area) before discharge from medical supervision. Several
scales to evaluate recovery have been devised and validated. A recently described and simple
evaluation tool may be the ability of the infant or child to remain awake for at least 20
minutes when placed in a quiet environment.
G13: The notes must: Include the name and signature of the operator together with the
name(s) of the assistants. Contain a clear treatment plan, completed medical history and
consent form, appropriate radiographs and briefly give an account of the reason for the
need for sedation. Document the operative treatment that was performed, the name of the
drug, concentration and batch number (if appropriate), dosage, route and duration of
sedation. State which monitors were used (as appropriate) together with their readings.
Include a time-based record where appropriate. (SIGN Grade C, no references cited)
G14: Advice given on eating and drinking must be recorded in the patient’s clinical records.
There must be a written contemporaneous record of the monitoring of the patient that is in
accordance with the clinical sedation technique used.
Records of the maintenance of equipment must be retained and made available for
subsequent formal inspections.
Records of the audit process and outcomes from them must be maintained and be available
for inspection.
Sedation teams must maintain high quality full clinical records and a written or electronic
clinical log. Each clinical team must maintain continuous and contemporaneous records of
the number and types of sedation cases performed as well as the rate of any complications
that may have arisen.
G15: Ensure that data from continuous monitoring during sedation are clearly documented
in the healthcare record. (expert opinion)
G16: Accurate and contemporaneous entries on the clinical records should be kept. It is
recommended that the documentation includes: A fully recorded medical history including
prescribed and self-prescribed medication [alcohol / tobacco / drugs]; a previous dental
history; a previous conscious sedation / general anaesthetic history; the reason for selection
of conscious sedation on each occasion that it is planned; a pre-sedation assessment; any
individual patient requirements; written instructions provided pre- and post-operatively; the
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included. One (G13) identified that drug batch number should be recorded.
Other records recommended by G14 include those for maintenance of equipment, records of
the audit process and outcomes, and written or electronic logs for each clinical team
(number and types of sedation cases performed, rate of any complications that may have
arisen).
3. Subgroup considerations
None identified.
4. Balance of effects
It is unlikely that the information to be recorded would vary significantly between countries.
None identified
7. Acceptability
8. Feasibility
9. Other factors
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data, particularly for continuous observations. This will depend on the clinical situation and
the guidance should advise that the most important time to record monitoring data is when
any significant event occurs.
The 2016 update of guideline G10 added that expired carbon dioxide levels should be
recorded in the documentation relating to treatment.
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Question 7.2: For patients undergoing dental treatment under Appraisal refs:
sedation: G1, G3, G5, G8, G10,
what information should be provided to patients/carers/escorts G13, G14, G15, G16,
before and after sedation and in what format? G17
1. Summary of evidence
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alternatives. The information must also include relevant contact details of the care provider
as well as the out-of-hours contact details for emergency advice and services. Instructions for
the pre- and postoperative periods must be suitable for each age group of patients and their
escorts and carers. Further details of patient information for adults and young people and for
children are supplied.
Clear information must be provided that prepares patients for dental treatment under
sedation. This information should explain the procedure, the pharmacological process, and
the benefits and risks associated with the selected form of sedation. It should be imparted as
part of a face-to-face explanation to the patient at the time of clinical preoperative
assessment and must then be supported by the provision of written information. Best
practice in the process of consent dictates that this information should be provided prior to
the day of the procedure. In addition, information must be provided for patient escorts.
Verbal and written instructions for the post-operative period must be provided for both the
patient and the responsible adult escort. Examples of the written instructions are provided.
They must include the post-operative risks, pain control and possible postoperative
complications together with the aftercare arrangements and emergency contacts.
A separate sheet with escort instructions is required. Additional information is specified to be
provided for child patients.
G16: Patients during preparation for Conscious Sedation must receive careful verbal and
written instructions regarding its effects and their responsibilities both before and
immediately after it. The patient and escort should be provided with details of postoperative
risks, pain control and management of possible complications. Adequate information
regarding aftercare arrangements and emergency contact must also be provided.
G17: Pre- and postoperative instructions in writing must be given in advance of the
procedure to the child and the parent or guardian.
Ten guidelines of low (G3, G5, G8, G10, G14, G16, G17), moderate (G1, G13) or high (G15)
methodological rating provide recommendations about the information that should be
provided to patients and/or carers before and/or after sedation. Nine of these indicated
which format should be used, stating that written information should be provided. Several
specify that the information should be given both verbally and in writing (G1, G3, G10, G14,
G15, G16).
The range of information includes:
Before sedation:
• information on the recommended sedation technique e.g. aims and effects of the
sedation and what to expect, benefits, risks, alternatives
• fasting instructions
• post-operative instructions (to be provided in advance of treatment)
Also see Question 2.4 (What information should be provided to the patient before sedation).
After sedation:
• post-operative risks, possible postoperative complications and pain relief
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3. Subgroup considerations
4. Balance of effects
The consensus is that providing patient information is essential. Most recommend that this is
both verbal and written. Consideration should be given to when instructions are provided.
There is general agreement from the various guidelines identified, irrespective of where they
originated, that it is essential to provide both pre- and post-treatment information to
patients.
7. Acceptability
8. Feasibility
9. Other factors
Consideration should be given to what is the appropriate amount and level of patient
information i.e. providing sufficient information without overburdening the patient/carer.
Following recommended use of the patient information examples provided in G14 could
mean that, for example, an adult patient having intravenous sedation is provided with at
least 4 documents.
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Question 7.3: For patients undergoing dental treatment under Appraisal refs:
sedation: G1, G14, G15, G17
what additional information is required for child patients?
1. Summary of evidence
Several of the guidelines referenced in Questions 2.4, 6.3 and 7.2 are specific to sedation for
children, and generic information recommended for patients of any age including children is
described in those sections.
G14, G17 (low) and G15 (high methodological rating) recommend that information should
also be provided in an age appropriate format for children and young people and G14
provides examples. G1 agrees that bespoke information may be required for children.
3. Subgroup considerations
Consideration may have to be given to further subgroups within the child age range i.e.
young children. For written instructions, pictures may be required rather than text.
4. Balance of effects
7. Acceptability
Parents or carers may wish to be aware of information prior to it being given to children or
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8. Feasibility
9. Other factors
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Question 9.1: What generic and specific skills and training are Appraisal refs:
required for each member of the team and for each sedation G1, G2, G3, G5, G6,
technique? G8, G10, G13, G14,
G15, G16, G17
1. Summary of evidence
G1: Irrespective of educational background, the competencies required for safe sedation
and, crucially, rescue from sedation-related adverse events, must be the same. There must be
one standard for all, but the educational requirements and pathways to attain a common
standard will vary for different disciplines.
It is the responsibility of all disciplines using sedation techniques to ensure that their
trainees receive accredited training in the use of these techniques, to a clearly defined
national standard.
Specific training relevant to children is required.
Addressing the training needs requires that the necessary competencies for the safe
and appropriate administration of sedation and prompt recognition and treatment
of sedation-related complications, be defined and specified within approved
postgraduate training curricula. Trainees who will be expected to use conscious
sedation techniques within their sphere of practice on obtaining their Certificate
of Completion of Training (CCT), must demonstrate acquisition of the necessary
competencies at Annual Review of Competency Progression (ARCP), or through an
equivalent process. An exemplar core curriculum with required competencies is provided in
the guideline appendix.
Those continuing to be actively involved in administering sedation must be able to
demonstrate continued competency through maintenance of an appropriate level of
experience, and ongoing participation in relevant life-long learning/CPD programmes,
now necessary for revalidation.
Life support:
BLS (RCUK defined) with basic airway manoeuvres for minimal sedation/anxiolysis; ILS (RCUK
defined) with competency in the use of basic airway manoeuvres, airway adjuncts,
supraglottic devices and bag and mask ventilation for moderate sedation/analgesia
(conscious sedation).
The management of sedation-related complications and medical emergencies should be
regularly rehearsed as a team.
G2: Experienced practitioners with a high degree of competency gained through a
combination of instruction and experience are assumed to meet the educational criteria
described. Guideline aims to provide a consistent measure of acceptable predoctoral and
continuing education but is not intended to fit every program into the same rigid
educational mold. This is neither possible nor desirable. There must always be room for
innovation and improvement.
Teaching Administration of Minimal Sedation: General objectives are listed. Inhalation
Sedation (Nitrous Oxide/Oxygen) objectives and course content are listed, duration (min 14
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within their institutions. This responsibility includes establishing the scope of practice and
credentialing of practitioners administering sedation. Institutions must ensure that such
practitioners are trained, and that their scope of practice remains valid with relevant ongoing
professional development.
G6: Qualification and training requirements for the sedationist should acknowledge
differences in educational and training backgrounds.
Essential: Primary registrable dental qualification OR Primary registrable medical
qualification; Appropriate knowledge, skills, attitude, behaviour and aptitude in the field of
conscious sedation; training in standard sedation techniques; compliance with GMC/GDC
CPD recommendations for conscious sedation; compliance with contemporary standards;
evidence of training (even for anaesthetists) in specific alternative sedation techniques in an
appropriate environment; evidence of annual team training in Immediate Life Support or
equivalent.
It is clear that, for a medical graduate, a period of training in anaesthesia would provide
much of the requirement. For sedation in another clinical setting (first trimester termination
of pregnancy) satisfactory completion of two years' training in anaesthesia has been
recommended.
Desirable: postgraduate dental qualifications (e.g.: MFDS/MFGDP, MSc/Dip in sedation);
trainer in conscious sedation; postgraduate medical qualifications (e.g.: FRCA).
For entry to training in specific alternative techniques, practitioners must have: documented
experience of the relevant intravenous or inhalational standard techniques (at least 100 cases
over last 2 years); not less than 4 years post-registration experience in the United Kingdom
as a dental or medical practitioner.
Oral and intranasal sedation must only be administered by those: who are trained and
experienced in intravenous sedation; who are competent at intravenous cannulation; who are
competent in the management of sedation related complications; who have evidence of
training in these techniques.
G8: Nitrous oxide/oxygen must be administered only by appropriately licensed individuals,
or under the direct supervision thereof, according to state law. The practitioner responsible
for the treatment of the patient and/or the administration of analgesic/anxiolytic agents
must be trained in the use of such agents and techniques and appropriate emergency
response.
Training and certification in basic life support are required for all clinical personnel. These
individuals should participate in periodic review of the office’s emergency protocol, the
emergency drug cart, and simulated exercises to assure proper emergency management
response.
G10: The practitioner responsible for the treatment of the patient and/or the administration
of drugs for sedation must be competent to use such techniques, to provide the level of
monitoring provided in this guideline, and to manage complications of these techniques (ie,
to be able to rescue the patient). Because the level of intended sedation may be exceeded,
the practitioner must be sufficiently skilled to provide rescue should the child progress to a
level of deep sedation. The practitioner must be trained in, and capable of providing, at the
minimum, bag-valve-mask ventilation so as to be able to oxygenate a child who develops
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airway obstruction or apnea. Training in, and maintenance of, advanced pediatric airway skills
is required; regular skills reinforcement is strongly encouraged.
G13: The dental team must undergo appropriate training on a regular basis as determined
by competent authorities. It is essential that primary care dentists who sedate children
undergo training that is recognized by appropriate authorities and that their clinical skill and
knowledge relating to paediatric conscious sedation, including local anaesthesia, behavioural
management and the provision of operative dental care for children, is regularly updated.
The dental nurse should be appropriately trained in sedation techniques. Attainment of the
Certificate in Dental Sedation Nursing (CDSN) from the National Examining Board for Dental
Nurses (NEBDN) is encouraged. Specialist paediatric dentists are expected to have acquired
the necessary skills and competency for nitrous oxide inhalation conscious sedation, but such
individuals are still obliged to update themselves regularly and to adhere to national and
regional policy and procedure. (SIGN Grade C, no references cited)
G14: All members of the care team must have the relevant knowledge and skills for the
technique being used, as defined by their scope of practice and competencies. Clinical skills
are underpinned by validated education and training while knowledge and continuing
competence must be maintained through appropriate continuing professional development.
For revalidation in a sedation technique, a practitioner (all team members) must undergo a
minimum of 12 hours of CPD every 5 years that are relevant to the techniques practised.
For all conscious sedation techniques other than inhalation sedation with nitrous
oxide/oxygen, competence in cannulation is mandatory
All members of the delivery and care team must have undertaken appropriate validated
education and training and demonstrated an acceptable level of competence by means of a
robust assessment process. Educational courses intended to provide training in clinical
delivery of conscious sedation and to prepare the team for independent practice must be
assessed, be externally quality assured and incorporate supervised clinical practice.
Syllabuses for education and training of the dental team are described in Appendix 1 of the
report and include the ability to perform ILS/PILS and recognise and manage sedation-
related complication.
Dental sedation nurses must be trained and experienced in the sedation technique used
(NEBDN CDSN or equivalent; CDSN encouraged).
Transition arrangements are described and recommended for experienced practitioners to
maintain a service to patients.
It is essential that the team delivering care is able to recognise medical, dental or sedation-
related adverse events and manage them appropriately and safely. The dentist is responsible
for complications resulting from medical or dental emergencies; sedationist for
complications resulting from sedation or medical emergencies; dentist, dental hygienist and
therapist, sedationist and dental nurse must be competent in life support. There must be
clearly defined roles, rehearsal and evidence of scenario-based team training. The provider of
dental care and the provider of the sedation service must be able to maintain life support for
a patient until such time as the emergency services are able to attend.
All team members must have the necessary life support skills (ILS/PILS for all sedation
techniques).
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Practical training should include knowledge of the drugs and equipment used for conscious
sedation, and must be completed before the clinical training. Knowledge of management of
complications due to conscious sedation is essential. Training and experience should be
regularly updated and maintained.
Documented, contemporaneous supervised hands-on experience must be acquired for each
conscious sedation technique used. The minimum number of documented supervised cases
completed should be no less than those specified by appropriate authorities.
Dental auxiliary personnel assisting during conscious sedation sessions shall also have
appropriate but shorter training.
All clinical staff requires theory and practical training in basic life support. Basic life support
must conform to contemporary guidelines issued by national authorities and dental
associations.
Training can be through informal courses where clinical training is included or in theoretical
courses with clinical demonstrations in combinations with clinics where conscious sedation is
regularly performed for hands-on supervision. Those arranging such training have a duty to
ensure that the quality of training and trainers is appropriate and that all theoretical and
practical training is documented.
There is a lack of available evidence about sedation training and the training
recommendations made in the various guidelines are necessarily informed by expert opinion.
12 of the guidelines with low (G2, G3, G5, G6, G8, G10, G14, G16, G17), moderate (G1, G13)
and high (G15) methodological ratings provided information on sedation training. Points
from these have been further summarised below to highlight the recommendations that
specify what training they consider appropriate for each sedation technique, sedation team
member and patient group and whether they indicate that training should be
formal/validated.
Generic skills
As would be expected, all of the guidelines indicate that appropriate training, experience and
competency is required for the provision of dental sedation. Staff should have practical
experience in the techniques used, in monitoring and in managing complications.
Specific skills
Some of the guidelines (G1, G6, G14, G15) indicate that additional specific training/skills are
required e.g. for alternative/advanced techniques and/or paediatric patients. G15
recommends that a healthcare professional trained in delivering anaesthetic agents is
available to administer sevoflurane, propofol, opioids combined with ketamine.
Staff specific training
Two of the guidelines provide specific details of requirements for dental sedation nurses
(G13, G14). Both indicate that attainment of the NEBDN CSDN certificate (or equivalent; G14)
should be encouraged.
Training Curricula
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Sedation training curricula and learning objectives have been developed by various expert
groups, societies and organisations specialising in dental and/or sedation training. Examples
of curricula are also provided with some of the guidelines (G1, G2, G14, G17). Some of the
curricula available are specific for particular sedation techniques (basic or advanced), team
members (dentist, hygienist/therapist or nurse) or patient group (children, young people and
adults). The most recent curricula developed for the UK include:
• The Independent Expert Group on Training Standards for Sedation in Dentistry (IEGTSSD)
documents (www.saad.org.uk/documents):
o A Guide to Maintaining Professional Standards in Conscious Sedation for Dentistry,
2011;
o Advanced Conscious Sedation Techniques for Adult Dental Patients Training Syllabus,
2011;
o Advanced Conscious Sedation Techniques for Paediatric Patients Training Syllabus,
2011
• G1: Safe Sedation Practice for Healthcare Procedures, Standards and Guidance, 2013:
o Exemplar core curriculum for the safe use of conscious sedation
• G14: Standards for Conscious Sedation in the Provision of Dental Care, 2015:
o Syllabus 1: Dentists: Basic conscious sedation techniques for children, young people
and adults
o Syllabus 2: Dentists: Advanced conscious sedation for young people and adults
o Syllabus 3: Dentists: Advanced conscious sedation for children
o Syllabus 4: Dental hygienists and therapists: Inhalation sedation
o Syllabus 5: Dental nurses: Assisting during conscious sedation
Accepted standard of training/assessment
Five of the guidelines (G1, G3, G5, G13, G14) stipulate that sedation training should be
delivered by an approved provider. Others recommend that training should meet criteria
described in the guidelines and/or indicate that in-house training would be suitable. The
most recent UK guidelines (G1, G14) recommend that externally validated/accredited training
should now be required.
CPD
Several of the guidelines (G1, G2, G5, G14, G15, G17) recommend that competency should be
maintained through appropriate sedation experience and CPD training, although they do not
provide further details. G14 specifies 12 hours of verifiable CPD per 5 years.
Life support training
Most of the guidelines highlight the need for the team members to have life support training
and skills and it is accepted that they should be able to recognise and manage complications
until emergency services can attend. Several of the guidelines (G1, G3, G6, G8, G10, G14, G15,
G17) provide to various extents more specific details on the level of training/skills required
for sedation techniques, team members and patient groups.
These are as follows:
Minimal sedation/anxiolysis
G1: RC(UK) defined BLS with basic airway manoeuvers (all patients)
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3. Subgroup considerations
It may be appropriate for different team members to undergo different sedation training i.e.
different courses for dentists, dental nurses and dental hygienists/therapists (as is already the
case). Training recommendations could refer to courses tailored for different sedation
techniques e.g. SQA Inhalation Sedation for Dental Nurses and Intravenous Sedation for
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4. Balance of effects
Appropriate training is considered essential for patient safety, but there may be a balance
between the stringency of training requirements (e.g. the need for external accreditation)
and the risk of a negative impact on sedation provision for patients.
Authorities who can accredit training may vary between countries. The content of training
courses e.g. for life support may also vary.
Patients have an expectation that their healthcare providers will be properly trained.
7. Acceptability
8. Feasibility
Concern has been raised about the lack of validated/accredited training course places
available for sedation staff and the time it might take to get staff trained if in-house training
is not an acceptable route. There could be a substantial impact on the availability of trained
staff and therefore on sedation provision.
9. Other factors
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acceptable: these might also include the management of common sedation, medical and
dental emergencies.
IACSD confirmed that the key elements of life support training required are those to ensure
competency in Basic Life Support (BLS), the use of an Automatic External Defibrillator (AED)
and the use of airway adjuncts. Importantly the training should be appropriate for the age
groups of the patients to be treated and contextualised to the dental setting. There should
be an emphasis on regular team training. These requirements are consistent with the
Resuscitation Council (UK)’s Primary Dental Care - Quality Standards for CPR28
CPD:
IACSD confirmed via another FAQ response that ‘CPD and update courses offering only
knowledge and skills training do not need external accreditation’.
Use of equipment for delivering nitrous oxide/oxygen:
Concern has been raised about training relating to the safe use of equipment, particularly for
N2O delivery. The main concerns are about the hygiene of nose-masks etc and the risks to
staff of released N2O. The extent to which these are addressed in existing curricula and/or
practice inspections should be considered.
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competency could be provided (e.g. how many cases of sedation should be carried out a
year to remain competent). It was decided that it would be inappropriate to do so because
of the variation in individual circumstances (e.g. levels of previous experience, different
sedation techniques and patient groups and opportunity for practice).
CPD
The IACSD report recommends 12 hours of sedation related CPD every 5 years and indicates
that this should be verifiable (according to existing mechanisms) but does not have to be
accredited. This level of CPD is in line with that recommended by the IEGTSSD in A Guide to
Maintaining Professional Standards in Conscious Sedation for Dentistry, 2011
(www.saad.org.uk/documents/). The GDG agreed that while some stakeholders report
difficulty in accessing CPD, this was a reasonable level to recommend.
Professional development courses for managing e.g. difficult children, patients using non-
verbal communication etc could be signposted in the guidance. Some aspects are included
as learning outcomes in existing training courses (e.g. for nurses).
Team members already practising sedation
The GDG agreed that the guidance should recommend that experienced clinical team
members already carrying out sedation could continue to do so without having to complete
validated training, although they should comply with the requirements stipulated in the
IACSD report (G14, p87):
1. Sedation practitioners should maintain a log in either written or electronic form of all sedation cases
undertaken, with comprehensive details of patient type, baseline vital signs, sedation agent
used/route/dose/reversals/untoward incidents etc.
2. Sedation practitioners and their clinical teams must undertake the similar, validated* continuing
professional development required for those following the pathway of training recommended in this
report.
3. Sedation practitioners must undertake sedation based audit and reflection frequently and regularly
in each location sedation is provided.
4. Sedation practitioners and their clinical teams must be competent in the appropriate ‘rescue’ skills
described in this report for the techniques of conscious sedation that are practised.
5. Sedation practitioners must meet the requirements for the environment and equipment and the
patient pathway checklist described in Section 1: Care pathways.
6. Sedation practitioners in primary care should ensure that appropriate clinical governance is in place
to comply with the standards set in this report.
The records for points 1–6 above should be available to those who commission or carry responsibility for
NHS provision of conscious sedation for dentistry. These requirements also apply to those practising
conscious sedation for dentistry outwith the NHS.
* Note that the use of the term ‘validated’ here is incorrect and should be replaced with
‘verifiable’. CPD does not need external accreditation (see Section 9 above).
These requirements should apply to dental nurses and hygienists/therapists, as well as
dentists and other dental sedationists.
Team members new to sedation
All team members new to sedation (including dentists, dental nurses and dental
hygienist/therapists) should complete training appropriate to the sedation techniques used,
via a validated course including those accredited by IACSD or delivered by a recognised
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authority. Providers of in-house training may apply for IACSD accreditation for their
programme.
Interim arrangements
According to the IACSD report, April 2015 defines the cut off for those already providing
sedation and the start of the requirement for validated training. However, this date has not
been accepted by the UK CDOs. In recognition of the difficulties around accessing approved
training and clinical supervision, particularly for dental nurses, the GDG suggested that
interim arrangements should be recommended. One suggestion was that those providing in-
house or other forms of training should be able to continue, as long as the training is in line
with the syllabuses described in the IACSD report and an application for IACSD accreditation
has been submitted. Another suggestion was to simply have a delay after publication of the
guidance before the requirement for validated training come into force. The period of time
to which these interim arrangements should apply may be informed by further investigation
of the availability of approved training and supervisors. Deaneries or equivalent recognised
authorities should be encouraged to help with training provision.
Although the GDG acknowledged that these suggestions might help with difficulties in
implementing the training recommendations in the short-term, they agreed that it would not
be appropriate to include such interim recommendations in the guidance but they could
inform any related implementation plan.
Life Support Training
In light of the further clarification provided by IACSD regarding life support (see Section 9
above), the GDG agreed to make recommendations based on this information. Essentially
the requirements should be for life support training that includes basic life support, use of
AEDs and airway management, is age-appropriate and suitable for the dental setting and for
all team members.
Managing sedation-related complications
After further consideration the GDG agreed that an individual section on the management of
sedation-related complications should be included in the guidance. This a key safety issue in
the provision of sedation and specific training may not be included as part of life support
training. While members of the dental sedation team will have been trained in the
recognition and management of sedation-related complications, members of the wider
clinical team may not have undergone formal validated sedation training. The recognition
and management of sedation-related complications and other emergencies should be a
team responsibility and so the whole clinical team should participate in regular scenario-
based training. The roles and responsibilities of each team member should be established in
advance.
Key recommendation:
The overarching key recommendation for training should indicate that all members of the
dental sedation team have the knowledge and skills to safely and effectively deliver the
sedation technique used. This should be linked to the details provided in the training
sections that follow the recommendation.
Basis for Key Recommendation: Expert opinion
The recommendation reflects the critical importance for patient safety of the correct training
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Appendix 5 – Considered Judgement Forms Training (Clinical Question 9.1)
of staff involved in the provision of dental sedation and is consistent with currently
advocated professional practice.
Post-consultation revisions:
On reconsideration of the guidance relating to experienced members of the dental sedation
team, the GDG agreed that most of the elements described under the ‘transitional
arrangements’ in the IACSD report should apply to all members of the sedation team,
including those who were newly trained. Consequently, a new section on maintaining
knowledge and skills was added that applies to both staff new to sedation and experienced
members of the sedation team. The GDG agreed that this section would include advice on
maintaining a log of cases, CPD, audit and reflection and maintaining competence in
managing complications.
To highlight the importance of training and practice in the management of sedation related
complications, a further key recommendation was added to the training section. The GDG
agreed that this recommendation should advise that the clinical team together should be
competent in the recognition and management of sedation related complications.
Basis for Key Recommendation: Expert opinion
The recommendation reflects the critical importance for patient safety of training in the
management of sedation-related complications, which is consistent with current standard
professional practice.
During the guidance development period, there were developments relating to the
availability of validated training. These included that a significant number of training
programmes, including some for ‘in-house’ training had gained IACSD accreditation. In
addition, IACSD made available a scheme for approving clinical supervisors of newly trained
providers of sedation who are gaining experience prior to independent practice.
233
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