Lazaraki 2007.
Methods | Single‐centre parallel‐group randomized controlled trial conducted in Greece in 2004 | |
Participants | 126 adults who were 23 to 84 years of age undergoing colonoscopy for the first time | |
Interventions | Intravenous administration of: 1) 25 ‐ 50 mcg fentanyl (mean 36 mcg) 2) 2 ‐ 5 mg midazolam (mean 4.6 mg) |
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Outcomes |
Measured during the procedure: Discomfort, pain (0 = very well/no discomfort, 4 = unbearable) Incomplete procedures Vital signs Sedation reversal Measured after the procedure: Offset of sedation Participant satisfaction (measured in the trial as willingness to undergo another procedure with same medication) Anterograde amnesia (recalled procedures) |
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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 | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Monitoring was performed by a single specialist nurse blinded to the randomization |
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 |