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

Stokland 2003.

Methods Single‐centre parallel‐group randomized controlled trial conducted in Sweden
Participants 95 children referred for voiding cystourethrography (median age 2.2 years in midazolam group and 3.2 years in placebo group)
Interventions Intranasal midazolam given in a dose of 0.2 mg/kg body weight with a maximum dose of 5 mg
Placebo group was given saline 0.9 mg/ml sterile solution
Outcomes Incomplete procedures
Notes Conflicts of interest or funding sources were not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Low risk The children were stratified by gender and randomly allocated to 1 of 2 groups, midazolam or placebo, by opening a sealed envelope prepared in blocks of 4
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk The substances were available in bottles with serial numbers, but were otherwise of identical appearance
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Not reported
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