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Clinical Trial
. 2010 Sep;14(5):434-8.
doi: 10.1016/j.ejpn.2010.05.009. Epub 2010 Jun 15.

Efficacy and usability of buccal midazolam in controlling acute prolonged convulsive seizures in children

Affiliations
Clinical Trial

Efficacy and usability of buccal midazolam in controlling acute prolonged convulsive seizures in children

Mahmoud Reza Ashrafi et al. Eur J Paediatr Neurol. 2010 Sep.

Abstract

A Prolonged convulsive seizure is the most common neurological medical emergency with poor outcome. An ideal anticonvulsant should be easy-to-use, effective, and safe, and it should also have a long-lasting effect. Benzodiazepines, give via the intravenous or rectal route have generally been used as first-line drugs. In small children, IV access can be difficult and time consuming. Midazolam is a potent anticonvulsant and is rapidly absorbed from the rectal, nasal, and buccal mucosa. Our aim was to evaluate the efficacy and usability of buccal midazolam in controlling seizures in children with acute prolonged seizures, by comparing it with rectal diazepam. Ninety-eight patients were enrolled, with 49 patients in each treatment group. In the buccal midazolam group, 42 (88%) patients were controlled in less than 4 min of drug administration, and all of the patients were controlled within 5 min of drug administration. In the rectal diazepam group, 24 (49%) patients were controlled in less than 4 min and 40 (82%) patients were controlled within 5 min of drug administration. The time for drug administration and drug effect was significantly less with buccal midazolam than with rectal diazepam (p value<0.001). In the buccal midazolam group, 46 (94%) parents were satisfied with their child's treatment and route of drug administration while in the rectal diazepam group, 7 (14%) parents were satisfied. Buccal midazolam was significantly more acceptable than rectal diazepam (p value<0.001). In conclusion, buccal midazolam may be as effective as rectal diazepam but more convenient to use in the controlling acute prolonged seizures in children, especially in situations in which there is a difficulty in gaining IV access, for example, in infants.

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