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 |