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

Park 2006.

Methods Parallel
Location: South Korea
Funding: not stated
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)
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
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