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Tramadol oral solution: new drug. Poorly evaluated and potentially dangerous in children

    Prescrire International
    |June 28, 2005
    PubMed

    Insights

    Codeine is the standard step-2 opiate analgesic for children. Tramadol, a newer option, has limited trial data, potential harm, and unproven efficacy in pediatric pain management.

    Area of Science:

    • Pediatric Pharmacology
    • Pain Management
    • Drug Safety

    Background:

    • Codeine is the established step-2 opiate analgesic for children aged one year and older.
    • Tramadol, a step-2 opiate analgesic, is now approved for children aged three and older in France.

    Purpose of the Study:

    • To evaluate the evidence supporting the use of tramadol in pediatric pain management.
    • To compare the efficacy and safety of tramadol with existing analgesics in children.

    Main Methods:

    • Review of existing clinical trials and safety data for tramadol in pediatric populations.
    • Analysis of comparative studies between tramadol and other analgesics like codeine, paracetamol, and ibuprofen.

    Main Results:

    • Clinical trials for tramadol in children are limited to short-term postoperative pain.
    • Tramadol has not been directly compared to codeine or properly dosed paracetamol in pediatric trials.
    • Adverse effects of tramadol in children, such as vomiting, are frequent, and deaths from overdose have been reported, similar to codeine.

    Conclusions:

    • There is insufficient evidence to support the efficacy of tramadol in children.
    • The potential risks associated with tramadol in pediatric patients outweigh the documented benefits.
    • Prescribing tramadol for pediatric pain management is not currently justified due to its poorly documented efficacy and safety concerns.

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