Transdermal fentanyl in the management of children with chronic severe pain

Results from an international study

Authors

  • Julia C. Finkel M.D.,

    Corresponding author
    1. Department of Anesthesiology, George Washington University, Washington, DC
    2. Department of Pediatrics, George Washington University, Washington, DC
    3. Anesthesia Pain Management Service, Children's National Medical Center, Washington, DC
    4. Pediatric Pain Program, David Geffen School of Medicine, University of California–Los Angeles, Los Angeles, California
    • Anesthesia Pain Management Service, Children's National Medical Center, 111 Michigan Avenue, NW, Washington, DC 20010===

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    • Fax: (202) 884-5999

  • Allen Finley M.D.,

    1. Department of Pediatrics, George Washington University, Washington, DC
    2. Department of Anesthesia, Dalhousie University, Halifax, Nova Scotia, Canada
    3. Department of Psychology, Dalhousie University, Halifax, Nova Scotia, Canada
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  • Christine Greco M.D.,

    1. Pediatric Pain Management, IWK Health Centre, Halifax, Nova Scotia, Canada
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    • Dr. Greco acts as a consultant for Janssen Pharmaceuticals.

  • Steve J. Weisman M.D.,

    1. Pain Treatment Services, Children's Hospital, Boston, Massachusetts
    2. Pain Management, Children's Hospital of Wisconsin, Milwaukee, Wisconsin
    3. Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, Wisconsin
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  • Lonnie Zeltzer M.D.

    1. Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin
    2. Department of Pediatrics, David Geffen School of Medicine, University of California–Los Angeles, Los Angeles, California
    3. Department of Anesthesiology, David Geffen School of Medicine, University of California–Los Angeles, Los Angeles, California
    4. Department of Psychiatry, David Geffen School of Medicine, University of California–Los Angeles, Los Angeles, California
    5. Department of Biobehavioral Sciences, David Geffen School of Medicine, University of California–Los Angeles, Los Angeles, California
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    • Dr. Zeltzer has acted in the past as a consultant for Janssen Pharmaceuticals.


Abstract

BACKGROUND

The current study was conducted to assess the safety and tolerability of a transdermal fentanyl delivery system for the relief of chronic pain in a pediatric population, and also to validate titration recommendations and conversion to transdermal fentanyl from oral opioid therapy.

METHODS

This 15-day (with 3-month extension), single-arm, open-label trial was conducted at 66 sites in 10 countries. A total of 199 pediatric patients (ages 2–16 years) with both malignant and nonmalignant conditions who were receiving oral or parenteral opioids for moderate to severe chronic pain were enrolled. Transdermal fentanyl doses were titrated upward according to the rescue medication consumed during the previous application period. Degree of pain was assessed by patients and parents/guardians using visual and numeric scales. Level of play and quality of life were assessed using the Play Performance Scale (PPS) and the Child Health Questionnaire (CHQ). Adverse events were monitored on Days 1–15. Hypoventilation and sedation were monitored every 4 hours during the first 72 hours of the study.

RESULTS

A total of 173 patients completed the primary treatment period and 130 entered the extension phase. The average daily pain intensity scores were reported to have decreased by Day 16 and improvements in the mean PPS scores were observed to the end of the extension period. The CHQ scores demonstrated improvements in 11 of 12 domains after Month 1 of the extension period.

CONCLUSIONS

Transdermal fentanyl was found to be a safe and well tolerated alternative to oral opioid treatment for children ages 2–16 years who were previously exposed to opioid therapy. Cancer 2005. © 2005 American Cancer Society.

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