Sainpy 1984.
Methods | Parallel‐group single‐centre randomized controlled trial conducted in France | |
Participants | 64 adults who underwent a gastroduodenal endoscopy. Exclusion of myasthenia gravis, pregnancy, past history of adverse reaction to benzodiazepines, long‐term treatment with psychotropes | |
Interventions | Intravenous midazolam: 0.1 mg under 65 yrs and 0.085 mg over 65 yrs infused in 30 seconds Intravenous diazepam: 0.2 mg under 65 yrs and 0.15 mg over 65 yrs infused in 30 seconds |
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Outcomes |
Measured during the procedure: Discomfort/pain Measured after the procedure Duration of sedation Anterograde amnesia (defined by number of participants who recalled the procedure) |
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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 | Method not stated |
Allocation concealment (selection bias) | Low risk | Used sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The gastroenterologist was the only person blinded to sedative drug |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The gastroenterologist was the only person blinded to sedative drug |
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 |