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

Avalos‐Arenas 1998.

Methods Parallel design RCT
Funding: not stated
Location: Mexico
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
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