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. 2016 May 20;2016(5):CD009491. doi: 10.1002/14651858.CD009491.pub2

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)
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)
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