Summary of findings 5. Intranasal midazolam compared to placebo for sedation before procedures.
| Intranasal midazolam compared to placebo for sedation before procedures | ||||||
| Patient or population: Children requiring sedation before voiding cystourethrograms and adults undergoing MRI Settings: Medical imaging departments in Germany and Sweden Intervention: intranasal 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 | Intranasal midazolam | |||||
| Level of sedation on a sedation assessment scale | 54 (1 study) |
moderate1 | Deeper level of sedation was observed in the midazolam group (mean 3.15 (SD 0.36) in midazolam group; mean 2.56 (SD 0.64) in placebo group; P < 0.001). Level of sedation measured 15 minutes after medication by one of the authors using a five‐point sedation scale (1 = agitated, non‐co‐operative; 2 = alert, restless; 3 = calm, eyes spontaneously open; 4 = drowsy, responds to minor stimulation; 5 = asleep, rousable but does not respond to minor stimulation). | |||
| Numeric rating of anxiety or rated as anxious | 54 (1 study) |
moderate1 | Reduction in a numerical rating of anxiety among participants who received midazolam prior to magnetic resonance imaging procedure (mean 17.3 (SD 18.58) in midazolam group; mean 49.3 (SD 29.46) in placebo group; P < 0.001). Numerical rating of anxiety measured 15 minutes after medication on a Visual Analogue Scale of Anxiety comprised an undivided 100‐mm line, with 0 meaning “I am not anxious at all,” and 100 meaning “I am extremely anxious.” | |||
| Incomplete procedure | 81 per 1000 | 11 per 1000 (2 to 91) | RR 0.14 (0.02 to 1.12) | 149 (2 studies) | low2 | |
| 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 | No studies reported on this outcome | |||||
| 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. 2Downgraded two levels due to concerns about study limitations and imprecision.