Tolia 1990.
Methods | Single‐centre parallel‐group randomized controlled trial conducted in USA | |
Participants | 41 children undergoing upper GI endoscopy | |
Interventions | Intravenous administration of: 1) 0.1 ‐ 0.15 mg/kg midazolam 2) 0.2 ‐ 0.4 mg/kg diazepam |
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Outcomes |
Measured during procedures: Participant co‐operation Measured 24 hours after procedures: Anterograde amnesia (recalled procedures) Discomfort, pain |
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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) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both endoscopist and participant were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Both endoscopist and participant were blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Not analysed as intention‐to‐treat |
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 |