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. 2018 Dec 17;2018(12):CD003877. doi: 10.1002/14651858.CD003877.pub5

Somri 2012.

Methods Parallel design
Funding: not stated
Location: Israel
Participants Inclusion criteria: patients unable to tolerate dental treatment under behavioural management and local anaesthetic or in combination with nitrous oxide use
n = 90
Age range = 3 to 10 years
Mean age (SD) in years, weight (SD) in kg:
Group 1: 5.6 + 1.85, 19.2 + 3.68
Group 2: 5.6 + 1.67, 19.7 + 3.38
Group 3: 6.2 + 2.00, 20.3 + 3.65
Interventions Group 1: midazolam (0.5 mg/kg)
Group 2: midazolam (0.75 mg/kg)
Group 3: midazolam (1 mg/kg)
All orally
Outcomes Wisconsin sedation scale, Houpt behavioural rating scale, parent satisfaction
Notes Immobilisation with manual restraining used
Wisconsin level 5 (deep sedation) considered adequate
All children received 2 litres of oxygen during treatment
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomly assigned by sealed envelope technique"
Allocation concealment (selection bias) Unclear risk Not described
Blinding ‐ Participant Unclear risk Not described
Blinding ‐ Operator/sedationist Low risk Nursing staff administering the midazolam, specialist paediatric dentist and anaesthetist performing procedure and post‐operative discharge nurses were blinded
Blinding ‐ Outcome assessor Unclear risk Not described if the assessor was blinded
Incomplete outcome assessment Low risk All participants included in the outcome evaluation
Free of selective reporting Low risk All planned outcomes reported
Free of other bias Low risk No other bias