Lee 1989.
Methods | Single‐centre parallel‐group randomized controlled trial conducted in Jamaica | |
Participants | 149 adults undergoing upper GI endoscopy for the first time. 79 men with a mean age of 52.5 years (range 18 to 81) and 70 women with a mean age of 46 years (17 to 82 years) | |
Interventions | Intravenous administration of: Diazepam to a maximum of 0.15 mg/kg Midazolam to a maximum of 0.07 mg/kg No sedation (not used in this review) (47 participants) |
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Outcomes |
Measured during the procedure: Participant co‐operation Difficulty performing procedure Measured 24 to 48 hours after the procedure: Anterograde amnesia (defined by number of participants who recalled the procedure) Discomfort/pain (measured in the trial as 'uncomfortable') |
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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 | High risk | Not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The endoscopist who was unaware of the drug used completed a questionnaire to assess the participant co‐operation and difficulty performing procedure outcomes, but anterograde amnesia and discomfort/pain were not assessed in a blinded fashion (no information about participant blinding) |
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 |