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Effects of intranasal midazolam and rectal diazepam on acute convulsions in children: prospective randomized study
Tunç Fişgin1, Yavuz Gurer, Tahsin Teziç
1Pediatric Neurology Department, Dr Sami Ulus Child Health and Disease Centre, Telsizler-Ankara, Turkey. fisgint@turk.net
Insights
Intranasal midazolam is more effective than rectal diazepam for treating acute childhood convulsions. This study found midazolam had a higher success rate and required fewer additional medications, with no serious side effects observed.
Area of Science:
- Pediatric Neurology
- Emergency Medicine
- Pharmacology
Background:
- Acute convulsions in children require rapid and effective treatment.
- Rectal diazepam is a common first-line treatment, but its efficacy can be variable.
- Intranasal administration offers a potential alternative route for emergency medications.
Purpose of the Study:
- To compare the efficacy and safety of intranasal midazolam versus rectal diazepam for acute convulsion treatment in children.
- To establish a practical and safe treatment protocol for pediatric seizures.
Main Methods:
- A comparative study evaluating rectal diazepam and intranasal midazolam in pediatric patients experiencing acute convulsions.
- Seizure termination within 10 minutes was the primary efficacy endpoint.
- Statistical analysis was performed to determine significant differences in response rates and need for second-line medication.
Main Results:
- Intranasal midazolam demonstrated a higher response rate (87%) compared to rectal diazepam (60%) within 10 minutes.
- A statistically significant difference (P < .05) showed midazolam to be more effective.
- Fewer patients required a second medication in the midazolam group, also a statistically significant finding (P < .05).
Conclusions:
- Intranasal midazolam is a more effective anticonvulsant agent than rectal diazepam for acute childhood seizures.
- The intranasal route is easy to administer and was associated with no serious complications.
- Wider availability of intranasal midazolam formulations could significantly benefit emergency room physicians.
Abstract:
In this study, the effects and side effects of rectal diazepam and intranasal midazolam were compared in the treatment of acute convulsions in children to develop a practical and safe treatment protocol. In the diazepam group, the seizures of 13 (60%) patients terminated in 10 minutes; however, 9 (40%) patients did not respond. In the midazolam group, 20 (87%) patients responded in 10 minutes, but 3 (13%) patients did not respond. Regarding the anticonvulsant effect, midazolam was found to be more effective than diazepam, and the difference was statistically significant (P < .05). The necessity of a second drug for the seizures that did not stop with the first drug was higher in the diazepam group than the midazolam group, and the difference was statistically significant (P < .05). We conclude that as an antiepileptic agent, intranasal midazolam is more effective than rectal diazepam. After administration, we did not observe any serious complications. Further investigations are necessary; however, intranasal administration is easy, so if the nasal drop and spray forms used in some European countries and the United States are available worldwide, it will be very useful for physicians in the emergency room.