Rai 2007.
Methods | Parallel group RCT Location: India Funding: not stated |
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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 |
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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 |
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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 |