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

Bui 2002.

Methods Parallel group RCT
Location: USA
Funding: not stated
Participants Unco‐operative children
 n = 22
 Mean age (SD) in months:
 Group 1 (n = 11), 34 (6.28)
 Group 2 (n = 11), 33 (6.65)
Interventions Group 1: ketamine (10 mg/kg) + promethazine (1.1 mg/kg)
 Group 2: ketamine (10 mg/kg)
 All oral
Outcomes Houpt, adverse effects
Notes Papoose board
 35:65 nitrous oxide/oxygen given to all participants
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Randomly selected" ‐ method of sequence generation not described
Allocation concealment (selection bias) Unclear risk Independent person randomly selected, allocated and administered
Blinding ‐ Participant Low risk Study described as double‐blind ‐ operator, dentist/anaesthetist and patient did not know which regimen was selected
Blinding ‐ Operator/sedationist Low risk Study described as double‐blind ‐ operator, dentist/anaesthetist and patient did not know which regimen was selected
Blinding ‐ Outcome assessor Low risk Study described as double‐blind ‐ operator, dentist/anaesthetist and patient did not know which regimen was selected
Incomplete outcome assessment Low risk All randomised participants evaluated
Free of selective reporting Low risk All planned outcomes reported
Free of other bias Low risk No other bias