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

Rai 2007.

Methods Parallel group RCT
Location: India
Funding: not stated
Participants Inclusion criteria: healthy, unco‐operative, anxious and apprehensive children requiring oral prophylaxis/fluoride gel/restorations/extractions/composite fillings/pulp therapies
n = 30 (10 per group)
Age range: 3 to 6 years
Interventions Group 1: midazolam (0.1 mg/kg) (bolus) + 0.004 mg/kg/min infusion
Group 2: propofol (1 mg/kg) (bolus) + 0.06 mg/kg/min infusion
Group 3: ketamine (0.5 mg/kg) (bolus) + 0.01 mg/kg/min infusion
All intravenous
All children had premedication 1 hour before, comprising 0.5 mg/kg midazolam and atropine (0.6 mg), all drugs administered by anaesthetist
Outcomes Houpt
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Randomly divided" ‐ method of sequence generation not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding ‐ Participant Unclear risk Not described
Blinding ‐ Operator/sedationist Unclear risk Not described
Blinding ‐ Outcome assessor Unclear risk Not described
Incomplete outcome assessment High risk Numbers evaluated not stated
Free of selective reporting Low risk All planned outcomes reported
Free of other bias Unclear risk Very little information on participant demographics at baseline