Summary of findings 12. Summary of findings ‐ Intravenous midazolam compared with intravenous lorazepam.
| Intravenous midazolam compared with intravenous lorazepam for children with acute tonic‐clonic seizures | ||||||
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Patient or population: Children with acute tonic‐clonic seizures Settings: Hospital inpatients Intervention: Intravenous midazolam Comparison: Intravenous lorazepam | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Intravenous lorazepam | Intravenous midazolam | |||||
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Seizure cessation Follow‐up: up to 24 hours |
Seizures were terminated for all children in the Intravenous lorazepam group | Seizures were terminated for 39 out of 40 children in the intravenous midazolam group | RR 0.98 (0.91 to 1.04) | 80 (1 trial) |
⊕⊕⊕⊝ moderate1 | ‐ |
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Time from drug administration to termination of seizures Follow‐up: up to 24 hours |
The mean time to cessation of seizures was 91.12 seconds in the intravenous lorazepam group. | The mean time to cessation of seizures was 1.50 seconds higher in the intravenous midazolam group (9.37 seconds lower to 12.37 seconds higher) . | NA | 80 (1 trial) |
⊕⊕⊕⊝ moderate2 | ‐ |
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Incidence of respiratory depression Follow‐up: up to 24 hours |
There were no occurrences of respiratory depression in either group | NA | 80 (1 trial) |
⊕⊕⊕⊕ high | ‐ | |
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Additional drugs required to terminate the seizure: additional dose of the trial drug required Follow‐up: up to 24 hours |
No children in the intravenous lorazepam group required an additional dose of the trial drug. | One child in the intravenous midazolam group required an additional dose of the trial drug. | RR 3.00 (0.13 to 71.51) | 80 (1 trial) |
⊕⊕⊕⊝ moderate3 | ‐ |
|
Seizure recurrence within 24 hours Follow‐up: up to 24 hours |
50 per 1000 | 50 per 1000 (8 to 338) | RR 1.00 (0.15 to 6.76) | 80 (1 trial) |
⊕⊕⊕⊝ moderate3 | ‐ |
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Incidence of admissions to the ICU Follow‐up: NA |
Outcome not reported | NA | ‐ | |||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. 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; ICU: Intensive Care Unit; NA: Not applicable; 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 once due to risk of bias: the definition of the 'seizure cessation' outcome is not an appropriate criterion for judging seizure cessation. This definition is likely to have impacted upon results. 2Downgraded once due to imprecision: wide confidence intervals around the effect size. 3Downgraded once due to imprecision: wide confidence intervals around the effect size (due to low event rates in both treatment groups).