Avalos‐Arenas 1998.
Methods | Parallel design RCT Funding: not stated Location: Mexico |
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Participants | Inclusion criteria: ASA I healthy children undergoing dental procedures n = 40 Mean age (SD) in months and gender: Group 1 (n = 20), 27.7 (2.9), 13 male, 7 female Group 2 (n = 20), 29.2 (3.6), 14 male, 6 female |
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Interventions | Group 1: chloral hydrate (70 mg/kg) + placebo Group 2: chloral hydrate (70 mg/kg) + hydroxyzine (2 mg/kg) All oral, administered by nurse | |
Outcomes | Houpt | |
Notes | Papoose board | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomly assigned" ‐ method of sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding ‐ Participant | Low risk | Study described as double‐blind |
Blinding ‐ Operator/sedationist | Low risk | Quote: "dental procedures were completed by one dentist who was ignorant of the patient location group" |
Blinding ‐ Outcome assessor | Low risk | Study described as double‐blind, independent rater unaware of patient treatment |
Incomplete outcome assessment | High risk | Numbers evaluated not stated |
Free of selective reporting | Low risk | All planned outcomes reported |
Free of other bias | Low risk | No other bias |