Park 2006.
Methods | Parallel Location: South Korea Funding: not stated |
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Participants | Inclusion criteria: ASA I, under 6 years, 20 kg body weight, unco‐operative requiring sedation for dental treatment Mean age in months (SD), gender, mean weight in kg (SD): Group 1 (n = 15), 44.5 (14.1), 6 males and 9 females, 15.6 (2.7) Group 2 (n = 16), 34.3 (9.3), 11 males and 5 females, 15.1 (2.6) |
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Interventions | Group 1: chloral hydrate (60 mg/kg) + hydroxyzine (1 mg/kg). Both oral Group 2: chloral hydrate (60 mg/kg) (oral) + hydroxyzine (1 mg/kg) (oral) + midazolam (0.1 mg/kg) (submucosal) Administered by dentist |
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Outcomes | Houpt, requirement for restraint | |
Notes | 50% nitrous oxide/oxygen administered to all | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding ‐ Participant | High risk | Not blinded |
Blinding ‐ Operator/sedationist | High risk | Not blinded |
Blinding ‐ Outcome assessor | Low risk | Video used, assessor blinded |
Incomplete outcome assessment | Low risk | All outcomes reported |
Free of selective reporting | Low risk | Data from all subjects reported |
Free of other bias | Low risk | No other bias detected |