Younge 2001.
Methods | Single‐centre parallel‐group randomized controlled trial conducted in the United Kingdom | |
Participants | 59 children ages 1 to 7 needing laceration repair (mean age 4.1 years in both groups; 54% boys in midazolam group and 53% boys in ketamine group) | |
Interventions | Oral midazolam 0.7 mg/kg Oral ketamine 10 mg/kg |
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Outcomes |
Measured during the procedure: Level of sedation on a sedation assessment scale Offset time of sedation Vital signs Disinhibition/excitation |
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Notes | Reported that there were no conflicts of interest or funding received for the trial | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Drug solutions were pre‐prepared by the hospital pharmacy and numbered sequentially, randomly containing 1 or other drug |
Allocation concealment (selection bias) | Low risk | Drug solutions were pre‐prepared by the hospital pharmacy and numbered sequentially, randomly containing 1 or other drug |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals |
Selective reporting (reporting bias) | Unclear risk | No clear evidence that measured outcomes were not reported (trial protocols were not sought for confirmation) |
Other bias | Low risk | None expected |