Summary of findings 2. Intravenous midazolam compared to placebo for sedation before procedures.
| Intravenous midazolam compared to placebo for sedation before procedures | ||||||
| Patient or population: adults requiring sedation before gastrointestinal endoscopy and bronchoscopy Settings: hospitals in India, Iran, UK, Portugal and Japan Intervention: intravenous midazolam Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Intravenous midazolam | |||||
| Level of sedation on a sedation assessment scale | 100 (1 study) |
low1 | Participants who were randomized to midazolam were more sedated (the mean score on the Ramsay scale (1 to 6 with higher scores indicating the participant was more sedated) was 2.77 ± 1.19 in the midazolam group and 1.72 ± 0.50 in the placebo group. | |||
| Numeric rating of anxiety or rated as anxious | 100 (1 study) |
low1 | Authors of this trial reported that fewer participants who received midazolam were anxious (3/50 in midazolam group; 15/50 in placebo group) but results of statistical tests were not reported. | |||
| Incomplete procedures | No studies reported on this outcome | |||||
| Anterograde amnesia (defined by number of participants who recalled the procedure) | No studies reported on this outcome | |||||
| Disinhibition or excitation | No studies reported on this outcome | |||||
| Discomfort/pain | 167 (1 study) |
very low2 | There was no difference in the number of participants who had discomfort/pain during upper gastrointestinal endoscopy (3/85 in midazolam group; 4/82 in placebo group; P = 0.876). Measured in the trial as 'uncomfortable' | |||
| Allergic or anaphylactoid reaction | No studies reported on this outcome | |||||
| *The basis for the assumed risk is the control group risk across studies or the average risk for pooled data and the control group risk for single studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio. | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1Downgraded two levels due to concerns about study limitations and imprecision. 2Downgraded three levels due to very serious concerns about study limitations and imprecision.