Summary of findings 6. Summary of findings ‐ Buccal midazolam compared with intravenous diazepam.

Buccal midazolam compared with intravenous diazepam for children with acute tonic‐clonic seizures
Patient or population: Children with acute tonic‐clonic seizures Settings: Hospital inpatients Intervention: Buccal 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	Buccal midazolam
Seizure cessation Follow‐up: up to 24 hours	933 per 1000	849 per 1000 (747 to 961)	RR 0.91 (0.80 to 1.03)	120 (1 trial)	⊕⊕⊕⊕ high	‐
Time from drug administration to termination of seizures Follow‐up: up to 24 hours	The mean time to cessation of seizures was 1.13 minutes in the intravenous diazepam group.	The mean time to cessation of seizures was 0.56 minutes higher in the buccal diazepam group (0.29 to 0.83 minutes higher).	NA	120 (1 trial)	⊕⊕⊕⊝ moderate1	The mean time for initiation of treatment was significantly shorter in the buccal midazolam group (MD ‐1.09 minutes, 95% CI ‐1.31 to ‐0.87) and therefore the mean total time to controlling the seizures was significantly shorter in the buccal midazolam group compared to the intravenous diazepam group (MD ‐0.59, 95% CI ‐0.96 to ‐0.22)
Incidence of respiratory depression Follow‐up: up to 24 hours	There were no adverse events in either group		NA	120 (1 trial)	⊕⊕⊕⊕ high	‐
Additional drugs required to stop the seizure Follow‐up: NA	Outcome not reported				NA	‐
Seizure recurrence within 24 hours Follow‐up: NA	Outcome not reported				NA	‐
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; 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 applicability: the route of intervention of the drug has been shown to influence the outcome.