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Oromucosal midazolam: a guide to its use in paediatric patients with prolonged acute convulsive seizures
Lesley J Scott1, Katherine A Lyseng-Williamson, Karly P Garnock-Jones
1Adis, Auckland, New Zealand. demail@springer.com
Insights
Oromucosal midazolam effectively treats prolonged seizures in children, offering a more convenient alternative to rectal diazepam. This benzodiazepine treatment was found to be as effective as intravenous diazepam in clinical trials.
Area of Science:
- Pharmacology
- Pediatrics
- Neurology
Background:
- Acute, prolonged, convulsive seizures in pediatric patients require effective and accessible treatment.
- Rectal diazepam has been the standard treatment but presents administration challenges.
- Oromucosal midazolam (Buccolam™) offers a new therapeutic option for pediatric seizure management.
Purpose of the Study:
- To evaluate the efficacy and tolerability of oromucosal midazolam in treating acute, prolonged, convulsive seizures in children.
- To compare oromucosal midazolam with established treatments like rectal and intravenous diazepam.
- To highlight the advantages of oromucosal midazolam over existing therapies.
Main Methods:
- Clinical trials involving pediatric patients aged 3 months to <18 years with acute, prolonged, convulsive seizures.
- Administration of oromucosal midazolam via the oral mucosa.
- Comparison of seizure treatment outcomes with rectal diazepam and intravenous diazepam.
Main Results:
- Oromucosal midazolam demonstrated at least equivalent efficacy to rectal diazepam.
- Efficacy of oromucosal midazolam was comparable to intravenous diazepam.
- The treatment was generally well tolerated in the pediatric population.
Conclusions:
- Oromucosal midazolam is an effective treatment for prolonged seizures in pediatric patients.
- It offers a more convenient and socially acceptable administration route compared to rectal diazepam.
- This formulation provides a valuable alternative for managing pediatric convulsive seizures.
Abstract:
Oromucosal midazolam (Buccolam™), a benzodiazepine, is approved in the EU for the treatment of paediatric patients (aged 3 months to <18 years) with acute, prolonged, convulsive seizures. In clinical trials in children with prolonged, acute, convulsive seizures, oromucosal midazolam was at least as effective as rectal diazepam and as effective as intravenous diazepam in the treatment of seizures and was generally well tolerated. It has several advantages over rectal diazepam, the previous gold standard of treatment, such as having a more convenient and socially acceptable administration route.
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