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Nalmefene to prevent epidural narcotic side effects in pediatric patients: a pharmacokinetic and safety study

D A Rosen, J L Morris, K R Rosen

    Pharmacotherapy
    |July 25, 2000
    PubMed

    Insights

    Nalmefene demonstrated similar pharmacokinetics in children as in adults, indicating safe administration. However, the 1 microg/kg dose did not effectively prevent narcotic side effects from epidural anesthesia in pediatric patients.

    Area of Science:

    • Pharmacology
    • Pediatric Anesthesiology

    Background:

    • Epidural anesthesia is commonly used in pediatric surgery.
    • Narcotic analgesics administered epidurally can cause side effects like nausea, vomiting, and urinary retention.
    • Nalmefene, an opioid antagonist, is used in adults to counteract opioid effects.

    Purpose of the Study:

    • To evaluate the pharmacokinetics of nalmefene in children.
    • To assess the preliminary efficacy of nalmefene in preventing epidural-induced narcotic side effects in pediatric patients undergoing cardiothoracic surgery.

    Main Methods:

    • A double-blind, placebo-controlled study was conducted with 34 children (aged 2-12 years).
    • Patients received either intravenous bolus nalmefene (1 microg/kg) or a placebo.
    • Plasma nalmefene concentrations were measured, and pharmacokinetic parameters were analyzed using a limited sampling strategy and Bayesian analysis.

    Main Results:

    • Nalmefene pharmacokinetic parameters in children were similar to those reported in adults.
    • The initial disposition half-life was 0.36+/-0.11 hour, and the terminal elimination half-life was 8.7+/-2.3 hours.
    • The 1 microg/kg dose of nalmefene did not significantly prevent or reduce epidural narcotic-induced side effects (pain, nausea, vomiting, urinary retention) compared to placebo.

    Conclusions:

    • Nalmefene exhibits comparable pharmacokinetics in pediatric and adult populations.
    • The drug was safely administered to pediatric patients without causing unmanageable pain.
    • The studied dose of nalmefene was not effective in preventing common side effects associated with epidural narcotics in children.
    Abstract

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