A second-line option for conscious sedation of children for dental procedures
Submitting InstitutionNewcastle University
Unit of AssessmentAllied Health Professions, Dentistry, Nursing and Pharmacy
Summary Impact TypeHealth
Research Subject Area(s)
Medical and Health Sciences: Clinical Sciences
Summary of the impact
Anxiety before dental procedures is common in children, and is usually
managed by conscious
sedation of the patient. Previously, nitrous oxide inhalation was the only
method widely used in
primary care, so patients who could not be thus sedated were referred for
general anaesthesia. In
2010, NICE published the first national guideline on medical sedation,
which states that
administration of midazolam should be considered alongside the standard
technique of nitrous
oxide inhalation for sedation of children. That recommendation is based on
robust evidence, the
majority of which came from a series of randomised controlled clinical
trials carried out by
researchers at Newcastle University. Midazolam is now deployed as a
second-line sedation option
across the UK.
Key Newcastle University researchers
- Professor Nick Girdler, initially a Senior Lecturer, then from 2006 a
Professor of Sedation
- Dr Katherine Wilson, Honorary Clinical Tutor in the Department of
Dental Sciences. Wilson was
co-supervised by Professor Richard Welbury (University of Glasgow during
period), who helped plan five of the clinical trials.
A study published in 2011 of 552 child patients who underwent extractions
and minor surgery
found that two-thirds of patients reported being anxious or very anxious
(Lourenco-Matharu and Roberts, 2011, PMID: 21701471). When invasive
procedures need to be
performed, most children are given relative analgesia, which involves
managing the child's
behaviour and inducing mild conscious sedation by passing a combination of
nitrous oxide and
oxygen through the nose.
Previously, in cases where relative analgesia failed (estimates vary, but
approximately 15-20% of
child sedations), child patients were usually referred for general
anaesthesia. However, because
general anaesthesia is a more complex and higher risk intervention than
conscious sedation (the
former may only be carried out in hospital) and is much more expensive,
there was a pressing
need for another conscious sedation option.
Over a six year period (2002-7), Newcastle researchers published six
papers (R1-6) detailing the
results of clinical trials of the drug midazolam for conscious sedation of
children during dental
procedures (although in one study midazolam was used in combination with
nitrous oxide (R4)).
The comparator in each of the studies was either nitrous oxide combined
with oxygen or nitrous
oxide combined with oxygen and sevoflurane. Indicators of patient health
during treatment (blood
pressure, heart rate, arterial oxygen saturation), sedation scores,
patient anxiety levels and post-operative
satisfaction were recorded. Midazolam was administered orally (R1,
R2 and R5),
intravenously (R3, R4) or via the oral transmucosal route (R6).
Subjects were children between 10
and 16 years of age in four studies (R1, R2, R3, R6), and slightly younger
on average in two others
(6-14 years, R4; 5-10 years, R5).
The studies showed that intravenous, oral and buccal (transmucosal)
midazolam, in the hands of
fully experienced practitioners, could be used safely and effectively
during dental procedures for
conscious sedation of child patients.
References to the research
(Scopus citation data as at 31/7/13, Newcastle researchers in
R1. Wilson KE, Welbury RR, Girdler NM (2002). A
Randomised, Controlled, Crossover Trial of
Oral Midazolam and Nitrous Oxide for Paediatric Dental Sedation. Anaesthesia.
DOI: 10.1046/j.1365-2044.2002.02784.x 23 citations.
R2. Wilson KE, Welbury RR, Girdler NM (2002). A Study of
the Effectiveness of Oral Midazolam
Sedation for Orthodontic Extraction of Permanent Teeth in Children: a
Randomised, Controlled, Crossover Trial. British Dental Journal.
DOI:10.1038/sj.bdj.4801400 10 citations.
R3. Wilson KE, Girdler NM, Welbury RR (2003). Randomized,
Controlled, Cross-Over Clinical
Trial Comparing Intravenous Midazolam Sedation With Nitrous Oxide Sedation
Undergoing Dental Extractions. British Journal of Anaesthesia.
10.1093/bja/aeg278 27 citations.
R4. Averley PA, Girdler NM, Bond S, Steen N, Steele
J (2004). A Randomised Controlled Trial
of Paediatric Conscious Sedation for Dental Treatment Using Intravenous
Combined With Inhaled Nitrous Oxide or Nitrous Oxide/Sevoflurane. Anaesthesia.
DOI: 10.1111/j.1365-2044.2004.03805.x 15 citations.
R5. Wilson KE, Girdler NM, Welbury RR (2006). A comparison of
oral midazolam and nitrous
oxide sedation for dental extractions in children. Anaesthesia
10.1111/j.1365-2044.2006.04835.x 15 citations.
R6. Wilson KE, Welbury RR, Girdler NM (2007). Comparison
of Transmucosal Midazolam With
Inhalation Sedation for Dental Extractions in Children. A Randomized,
Trial. Acta Anaesthesiologica Scandinavica. 51(8):1062-1067. DOI:
Relevant funding award
2002-2006. The Department of Health £401,689. Developing the Evidence
Base for Effective
Paediatric Conscious Sedation Techniques: An Alternative to General
Details of the impact
In the past few years, 50,000-60,000 dental sedation procedures have been
carried out each year
on children in England and Wales (data from FOI request to the NHS
Business Services Authority).
The majority of those were standard inhalation sedations with nitrous
oxide and oxygen, which
induces a mild state of conscious sedation in patients. The technique is
called relative analgesia; it
has been used for a long time and has a very good safety record — hence it
is the first-line option
for sedation. However, in a proportion of child patients, inhalation
sedation is not adequate due to
non-compliance and dental treatment cannot be performed. A study published
in 2002 reported
that in a cohort of children receiving inhalation sedation within the
community dental service of one
primary care trust, 16% of dental procedures failed due to problems with
sedation (Bryan (2002)
PubMed ID: 12452982).
Previously, the only alternative to nitrous oxide for sedating children
had been dental general
anaesthesia, an unsatisfactory situation. Since 2002, general anaesthesia
has been prohibited in a
primary care setting and must be carried out in hospital. A hospital visit
for dental work is both an
unpleasant experience for the patient and is costly to the health service.
In 2010, the cost of a
dental general anaesthetic in hospital (staff and consumables) was
estimated to be £719.90, more
than 2.5 times the cost of a sedation procedure carried out by a primary
care referral service
(£273.01): see NICE clinical guideline 112: www.nice.org.uk/nicemedia/live/13296/52185/52185.pdf.
Guidelines on dental sedation
In 2010, NICE published the guideline Sedation for diagnostic and
therapeutic procedures in
children and young people (Ev a). It states:
"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" (pg 19).
The full-length guideline development document, which accompanies the
concise guideline, shows
that all five trials considered by the Guideline Development Group which
involved a direct
comparison between nitrous oxide and midazolam were from Newcastle
University (Ev b).
The results of a sixth clinical trial performed at Newcastle University
(R4), which compared
intravenous midazolam plus nitrous oxide with nitrous oxide plus
sevoflurane was also examined
by the guideline development group — although combination techniques are
recommended in the guideline.
The NICE guideline applies to all NHS dental services in England and
Wales. Dental practices in
Scotland follow the Scottish Dental Clinical Effectiveness Programme
guideline on dental sedation
of adults and children, which was updated in June 2012. On child sedation,
the updated guideline
"...intravenous sedation [midazolam is recommended earlier as the
drug of choice] of paediatric
dental patients has been reported as a safe and effective technique..."
"...intravenous sedation for children is appropriate in a minority of
cases." (Ev c)
Two studies are cited as supporting this, both of which were carried out
at Newcastle University
and involved use of midazolam (R3 and R4).
The guidelines also state (citing R2, a trial of oral midazolam):
"Oral and transmucosal sedation is appropriate in a minority of cases"
but only where "titratable
techniques (inhalation and intravenous sedation) are deemed to be
inappropriate." (Ev c).
The President of the Society for the Advancement of Anaesthesia in
Dentistry (SAAD) confirms
that "a large majority [of SAAD members] now apply the current
guidelines." (Ev d).
Sedation in practice
Sedation with midazolam, usually administered intravenously and sometimes
in combination with
other drugs, is now the main alternative to nitrous oxide for conscious
sedation of children. The
group that developed the 2010 NICE guideline stated in their report that:
"the use of midazolam
alone in dental procedures in adolescents and in oesophago-gastroscopy
is common." (Ev b).
The NHS Business Services Authority does not centrally record data on the
types of dental
sedations paid for by the NHS in the UK (FOI response 3449), and there is
no recently published
audit of sedation practice containing that information. Nevertheless, we
have statements from
several sedation providers, two of which* were named by the NHS
Authority as belonging to the top ten providers of dental sedations
to children on referral in the
UK in 2011-12, which indicate that sedation with intravenous midazolam is
- [text removed for publication]* (Ev e).
- [text removed for publication]* (Ev f).
- The Queensway Dental Clinic, Billingham, Teesside is one of the larger
clinics in England. It has received around 9,000 referred patients per
year over the last few
years, and in the year 2012-13 approximately 3,621 children were sedated
intravenous midazolam in combination with nitrous oxide, sevoflurane
and/or fentanyl where
appropriate (Ev g).
- Cumbria Partnership NHS Foundation Trust, Leeds Teaching Hospitals NHS
Newcastle upon Tyne Hospitals NHS Foundation Trust have all acknowledged
in responses to
FOI requests that they carry out child dental sedations with intravenous
appropriate (Ev h).
In the UK, professional training in paediatric conscious sedation has
adapted to reflect that
midazolam is now the standard alternative to nitrous oxide.
The UCL Eastman Dental Institute is the largest postgraduate dental
school in Europe and is a
world-leading academic centre for dentistry. They have confirmed in a
statement that their
Paediatric Dentistry DDent programme includes both teaching and practical
intravenous midazolam sedation (Ev i). Also, in December 2011 the
Independent Expert Group for
Training Standards on Sedation in Dentistry (whose members overlap those
of SAAD) released a
training syllabus on advanced conscious sedation techniques which
include use of midazolam in
children (Ev j). While sedation courses provide dentists with the
underpinning knowledge for
alternative conscious sedation of children, SAAD strongly advises that
experience should be acquired before independent practice. To facilitate
this, SAAD and the
Dental Sedation Teachers' Group provide a mentor list that details the
contacts of around 50
experienced sedation dentists (almost all in the UK, a few elsewhere in
Europe) who can supervise
trainees. In the 2011 list, 13 of the mentors were listed as able to
supervise and train dentists in
intravenous sedation of children (Ev g).
Sources to corroborate the impact
Ev a. Sedation for diagnostic and therapeutic procedures in children and
young people (concise
guideline). National Institute for Health and Clinical Excellence,
December 2010. (Quotation
from page 19.) http://www.nice.org.uk/nicemedia/live/13296/52130/52130.pdf
Ev b. Sedation for diagnostic and therapeutic procedures in children and
young people (full
guideline, with working of guideline development group). National Clinical
December 2010. (Table from page 236.)
Ev c. Conscious Sedation in Dentistry: Dental Clinical Guidance. Scottish
Effectiveness Programme, June 2012. Quotations from Section 4: Conscious
Ev d. Statement from the President of the Society for the Advancement of
Anaesthesia in Dentistry
Ev e. Statement from [text removed for publication]
Ev f. Statement from [text removed for publication].
Ev g. Statement provided by a Managing Partner at the Queensway Dental
Clinic, Teesside. (Also
provided the 2011 list of sedation mentors published by SAAD and the
Ev h. Freedom Of Information responses from Cumbria Partnership NHS
Foundation Trust, Leeds
Teaching Hospitals NHS Trust and Newcastle upon Tyne Hospitals NHS
Ev i. Statement from Unit Head, UCL Eastman Dental Institute.
Ev j. Advanced conscious sedation techniques for paediatric dental
patients. Training syllabus.
Independent Expert Group on Training Standards for Sedation in Dentistry