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

Faytrouny 2007.

Methods Parallel group RCT
Funding: not stated
Location: Turkey
Participants Inclusion criteria: unco‐operative fearful healthy children, ASA I, requiring sedation due to Frankl score of definitely negative or negative
n = 30, 14 females, 16 males
Mean age (SD) months:
Group 1 (n = 15), 61.9 (11.9)
Group 2 (n = 15), 53.7 (12.8)
Interventions Group 1: hydroxyzine (20 mg 24 hours before) + hydroxyzine (3.7 mg/kg at the appointment)
Group 2: hydroxyzine (3.7 mg/kg at the appointment)
All oral
Outcomes Houpt
Notes 20 mg/kg as stated in the text a mistake as this appears to be high. 20 mg in the abstract, presumably this is the correct value
50:50 nitrous oxide/oxygen given to all participants
Pediwrap used after sedation achieved
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Subjects were assigned randomly" ‐ method of sequence generation not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding ‐ Participant High risk Drugs given at home by parents or administered at clinic by the assistant
Blinding ‐ Operator/sedationist Low risk Quote: "Blinded to subject group assignment"
Blinding ‐ Outcome assessor Unclear risk Outcomes assessed by the "monitoring dentist." Unclear whether this person was blinded to 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