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 |
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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 |