Kuganeswaran 1999.
| Methods | Single‐centre parallel‐group randomized controlled trial conducted in USA | |
| Participants | 99 adults undergoing sigmoidoscopy (age 51 ± 2 years; 13 men and 35 women) | |
| Interventions | 1) Oral midazolam 7.5 mg (participants were asked to swish medication in mouth 15 times before swallowing to allow improved absorption by the oral mucosa) 2) Placebo |
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| Outcomes |
Measured during the procedure: Level of sedation using a sedation assessment scale (scores ranged from 0 = awake to 3 = asleep, responsive only to direct verbal or physical stimulus) Numerical rating of anxiety reported by proceduralist and participant (0 = no anxiety; 10 = severe anxiety) Discomfort/pain reported by proceduralist and participant (0 = no pain; 10 = severe pain) Vital signs (hypotension) Incomplete procedures Measured after the procedure: Participant satisfaction (refuse repeat procedure with same sedation) Participant satisfaction (participant considered sedation was not adequate) Anterograde amnesia (defined by number of participants who recalled the procedure) |
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| Notes | Conflicts of interest were not reported but it was noted that Roche Pharmaceuticals provided the study medications and "funded in part" the study. The role of the funder in design, analysis or reporting was not disclosed | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random‐number table |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind ‐ "the study medication was prepared by the inpatient pharmacy and physicians, nurses and patients were blinded to its identity" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind ‐ "the study medication was prepared by the inpatient pharmacy and physicians, nurses and patients were blinded to its identity" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 participants withdrew before receiving medication |
| 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 |