Summary of findings 9. Summary of findings ‐ Intramuscular midazolam compared with intravenous diazepam.
| Intramuscular midazolam compared with intravenous diazepam for children with acute tonic‐clonic seizures | ||||||
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Patient or population: Children with acute tonic‐clonic seizures Settings: Hospital inpatients Intervention: Intramsucular 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 | |||||
| Intravenous diazepam | Intramsucular midazolam | |||||
|
Seizure cessation Follow‐up: up to 24 hours |
929 per 1000 | 901 per 1000 (808 to 1000) |
RR 0.97 (0.87 to 1.09) |
105 (2 trials) | ⊕⊕⊝⊝ low1,2 | ‐ |
|
Time from drug administration to stopping of seizures: total time to seizure cessation Follow‐up: up to 24 hours |
The mean total time to cessation of seizures was 2.68 minutes lower (3.94 to 1.42 minutes lower) in the intramuscular midazolam group compared to the intravenous diazepam group | NA | 105 (2 trials) | ⊕⊝⊝⊝ very low1, 2, 3 | One trial also showed that the initiation of treatment was significantly shorter in the intramuscular midazolam group (MD ‐4.50 minutes (‐6.68 to ‐2.32)) but there was no significant difference between treatments for the time to drug effect (MD 1.10 minutes (95% CI ‐0.91 to 3.11) | |
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Incidence of respiratory depression Follow‐up: up to 24 hours |
There were no adverse events or complications in either trial | NA | 105 (2 trials) | ⊕⊕⊝⊝ low1, 2 | ‐ | |
|
Additional drugs required to terminate the seizure Follow‐up: up to 24 hours |
71 per 1000 | 96 per 1000 (25 to 366) |
RR 1.34 (0.35 to 5.13) |
105 (2 trials) | ⊕⊝⊝⊝ very low1, 2, 4 | ‐ |
|
Seizure recurrence within 24 hours: within one hour Follow‐up: up to 24 hours |
364 per 1000 | 309 per 1000 (98 to 983) |
RR 0.85 (0.27 to 2.62) |
24 (1 trial) |
⊕⊝⊝⊝ very low1, 2, 4 | There was also no significant difference between treatments at within 15 minutes (RR: 0.85 (95% CI 0.06,to12.01) |
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Incidence of admissions to the ICU Follow‐up: up to 24 hours |
There were no admissions to the ICU | NA | 81 (1 trial) |
⊕⊕⊕⊝ moderate1 | ‐ | |
| *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; MD: Mean difference; 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: in both included trials, methods of randomisation were unclear so the trials may be at risk of selection bias. 2Downgraded once due to applicability: one child was randomised twice in one trial and included in both groups. It was not possible to identify this child in analysis and results are not adjusted for the correlation between measurements from the same child. 3Downgraded once due to applicability: the route of intervention of the drug has been shown to influence the outcome. 4Downgraded once due to imprecision: wide confidence intervals around the effect size or pooled effect size (due to low event rates in both treatment groups).