Cochrane · intervention · CD003877

Sedation of children undergoing dental treatment

Ashley, PF, Chaudhary, M, Lourenço‐Matharu, L · Cochrane Database of Systematic Reviews · 2018 · Cochrane Library

Oral HealthPain control and patient management5 versionsAMSTAR 2: not assessed
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
19
current version
GRADE rated
17
No studies
1
Included studies
50
as reported
No studies 1 · 5.3%Ungraded 1 · 5.3%Very low 15 · 78.9%Low 1 · 5.3%Moderate 1 · 5.3%High 0 · 0%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Review question

ElementPlanned (methods)Found (results)
PopulationChildren and adolescents aged 0 to 16 years (including children with specific medical or behavioural problems) having simple restorative treatment with local anaesthesia (e.g. fillings, stainless steel crowns), simple extractions or management of dental trauma; children having complex surgical procedures excludedStudies from 16 countries (greatest proportion USA, n=12, 24%); age 1 to 16 years (>=39 studies all subjects 6 or under); mean age approx 4.8 years; mean 74 participants per study; 3704 in total
InterventionAny sedative agent via any route of administration that can be administered by a dentist, anaesthetist, sedationist or dental auxiliary in an outpatient/dental office setting; studies inducing deep sedation excludedChloral hydrate (n=3); Chloral hydrate + hydroxyzine (n=6); Chloral hydrate + hydroxyzine + midazolam (n=1); Chloral hydrate + promethazine (n=1); Dexmedetomidine (n=2); Diazepam (n=1); Hydroxyzine (n=3); Ketamine (n=7); Ketamine + promethazine (n=1); Ketamine + midazolam (n=3); Ketamine + midazolam + sevoflurane (n=1); Melatonin (n=1); Meperidine (n=1); Meperidine + promethazine (n=2); Midazolam (n=27); Midazolam + acetaminophen (n=1); Midazolam + fentanyl (n=1); Midazolam + hydroxyzine (n=1); Midazolam + nitrous oxide/oxygen (n=1); Midazolam + ketamine (n=5); Midazolam + sevoflurane + nitrous oxide/oxygen (n=2); Midazolam + tramadol (n=1); Nitrous oxide/oxygen (n=5); Promethazine (n=1); Propofol (n=1); Sevoflurane + nitrous oxide/oxygen (n=1); Sufentanil (n=1); Tramadol (n=1); Triazolam (n=1); Triclofos (n=2); Trimeprazine + methadone (n=1); Trimeprazine + physeptone (n=1); Zolpidem (n=2); Zolpidem + tramadol (n=1)
ComparisonPlacebo (including no intervention); alternative sedation agent; different dosage of the same agentPlacebo (n=12); No intervention (n=1)
OutcomesBehaviour (primary); Completion of treatment (yes/no); Postoperative anxiety; Adverse eventsBehaviour (n=50); Completion of treatment (n=50); Postoperative anxiety (n=50); Adverse events (n=50)
Study designsRandomised controlled trials (including cluster-randomised); quasi-randomised and cross-over trials excludedRandomised controlled trials
TimingNot reportedNot reported

Search date: 22 February 2018. Databases: Cochrane Oral Health's Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE Ovid; Embase Ovid

Questions and results

Show all 5 versions

Chloral hydrate vs Placebo (including no intervention)

Population: Children and adolescents (0 to 16 years) needing dental treatment
7 questions
OutcomeEffectEvidenceStatus / GRADE
Good or better behaviour
RR 1.33 [0.80, 2.22]
176 [-106, 467] per 1000
1 study · 60 participantsVery low
Downgraded: risk of bias, imprecision
Behaviour (Houpt/behavioural score)
SMD 0.69 [0.13, 1.26]1 study · 52 participantsVery low
Downgraded: risk of bias, imprecision
Behaviour
Moreira 2013: 0.5 mg/kg midazolam + 3 mg/kg ketamine produced significantly better behaviour than placebo and oral midazolam (P=0.03); not included in meta-analysis / not GRADE-rated. Narrative.1 studyUngraded
Good or better behaviour
RR 5.33 [1.45, 19.64]
578 [60, 867] per 1000
1 study · 60 participantsLow
Downgraded: risk of bias, imprecision
Behaviour (Houpt/behavioural score)
SMD 0.62 [-0.28, 1.53]1 study · 20 participantsVery low
Downgraded: risk of bias, imprecision
Behaviour (Houpt/behavioural score)
SMD 1.21 [0.24, 2.18]1 study · 20 participantsVery low
Downgraded: risk of bias, imprecision
Behaviour (Houpt/behavioural score)
SMD 1.96 [1.59, 2.33]6 studies · 202 participantsModerate
Downgraded: risk of bias

Midazolam (any mode of delivery) vs Different dosage of the same sedative

Population: Children and adolescents (0 to 16 years) needing dental treatment
2 questions
OutcomeEffectEvidenceStatus / GRADE
Behaviour
Any behavioural score - Midazolam (any mode of delivery): 394 (10 studies); VERY LOW. Insufficient evidence to determine whether any specific dose of intranasal midazolam is effective; weak evidence oral midazolam…10 studies · 394 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency
Behaviour
Any behavioural score - Hydroxyzine: 30 (1 study); VERY LOW. Insufficient evidence to determine whether any specific dose of hydroxyzine is effective.1 study · 30 participantsVery low
Downgraded: risk of bias, imprecision

Intravenous midazolam vs A different sedative agent

Population: Children and adolescents (0 to 16 years) needing dental treatment
9 questions
OutcomeEffectEvidenceStatus / GRADE
Behaviour
Any behavioural score - Intravenous midazolam versus (other sedatives): 70 (2); VERY LOW2 studies · 70 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency
Behaviour
Any behavioural score - Ketamine versus (other sedatives): 494 (8); VERY LOW8 studies · 494 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency
Behaviour
Any behavioural score - Chloral hydrate/promethazine versus (other sedatives): 24 (1); VERY LOW1 study · 24 participantsVery low
Downgraded: risk of bias, imprecision
Behaviour
Any behavioural score - Dexmedetomidine versus (other sedatives): 120 (2); VERY LOW2 studies · 120 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency
Behaviour
Any behavioural score - Chloral hydrate/hydroxyzine versus (other sedatives): 235 (6); VERY LOW6 studies · 235 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency
Behaviour
Any behavioural score - Rectal midazolam versus (other sedatives): 90 (1); VERY LOW1 study · 90 participantsVery low
Downgraded: risk of bias, imprecision
Behaviour
Any behavioural score - Sevoflurane versus (other sedatives): 1140 (3); VERY LOW3 studies · 1140 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency
Behaviour
Any behavioural score - Ketamine/midazolam versus (other sedatives): 27 (1); VERY LOW1 study · 27 participantsVery low
Downgraded: risk of bias, imprecision
Behaviour
Any behavioural score - Oral midazolam versus (other sedatives): 654 (7); VERY LOW7 studies · 654 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency

Sedation

Population: Medically compromised children (ASA III+) or children with learning/behavioural difficulties needing dental treatment
1 question
OutcomeEffectEvidenceStatus / GRADE
Outcome NR
'Some of the techniques described may be useful in the management of medically compromised patients, but at present there are no studies carried out in these groups.' (Discussion) Explicit evidence gap.0 studiesNo studies