Faytrouny 2007.
Methods | Parallel group RCT Funding: not stated Location: Turkey |
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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) |
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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 |
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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 |
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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 |