Midazolam oral transmucosal route. An alternative to rectal diazepam for some children

    Prescrire International
    |August 17, 2013
    PubMed

    Insights

    Rectal diazepam is the standard treatment for prolonged seizures in children outside hospitals. Midazolam oromucosal solution offers an alternative, with similar effectiveness but potential risks like respiratory depression.

    Area of Science:

    • Pediatric Emergency Medicine
    • Clinical Pharmacology
    • Neurology

    Background:

    • Prolonged convulsive seizures in children are life-threatening emergencies.
    • Rectal diazepam is the established first-line treatment in pre-hospital settings.
    • Midazolam oromucosal solution is a newer, authorized alternative for oral transmucosal administration.

    Purpose of the Study:

    • To evaluate the efficacy and safety of midazolam oromucosal solution compared to rectal diazepam for pediatric convulsive seizures.
    • To review the available evidence on midazolam oromucosal solution's effectiveness and adverse effects.

    Main Methods:

    • Review of five clinical trials conducted in specialized centers.
    • Comparison of seizure duration and recurrence rates between midazolam oromucosal and rectal diazepam groups.
    • Analysis of adverse events, including respiratory depression and potential drug interactions.

    Main Results:

    • Midazolam oromucosal solution appears at least as effective as rectal diazepam in reducing seizure duration and preventing early recurrence.
    • Evidence supporting these findings is considered weak.
    • Adverse effects are similar to rectal diazepam, with respiratory depression occurring in 1-5% of patients.

    Conclusions:

    • Midazolam oromucosal solution is a viable alternative to rectal diazepam for children over 6 months with convulsive seizures, particularly when rectal administration is challenging.
    • Potential risks include respiratory depression and overdose in infants under 6 months.
    • Drug interactions with certain anticonvulsants may reduce efficacy.

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