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. 2016 May 20;2016(5):CD009491. doi: 10.1002/14651858.CD009491.pub2

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
Outcomes Measured during the procedure:
Level of sedation on a sedation assessment scale
Offset time of sedation
Vital signs
Disinhibition/excitation
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