Summary of findings for the main comparison. Intravenous midazolam compared to diazepam for sedation before procedures.
| Intravenous midazolam compared to diazepam for sedation before procedures | ||||||
| Patient or population: adults and children requiring sedation before gastrointestinal endoscopy and bronchoscopy Settings: hospitals in UK, USA, Mexico, India, Italy, Finland, Jamaica, France, Jordan and Turkey Intervention: intravenous midazolam Comparison: intravenous diazepam | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Diazepam | Midazolam | |||||
| Level of sedation on a sedation assessment scale | 75 (1 study) |
very low1 | The mean level of sedation in the midazolam group was 3.2 and the mean level of sedation in the diazepam group was 2.7 on a scale that ranged from 0 to 4 (higher scores indicating more sedation). Measured with a scale that ranged from 0 ‐ 4 (higher scores indicating the participant was more sedated). | |||
| Numeric rating of anxiety or rated as anxious | 167 per 1000 | 133 per 1000 (65 to 270) | RR 0.80 (0.39 to 1.62) | 175 (2 studies) | low2 | Effect estimate calculated for number of participants rated as anxious |
| Incomplete procedure | 170 (1 study) |
All procedures were completed in both groups | ||||
| Anterograde amnesia (defined by number of participants who recalled the procedure) | 481 per 1000 | 216 per 1000 (144 to 318) | RR 0.45 (0.3 to 0.66) | 587 (9 studies) | low3 | |
| Disinhibition or excitation | No studies reported on this outcome | |||||
| Discomfort/pain | 202 per 1000 | 121 per 1000 (48 to 301) | RR 0.60 (0.24 to 1.49) | 415 (5 studies) | low2 | |
| 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 by three levels due to very serious concerns about study limitations (risk of bias) and very serious concerns about imprecision. 2Downgraded by two levels due to very serious concerns about study limitations (risk of bias) and imprecision. 3Downgraded by two level due to concerns about study limitations and inconsistency.