Transdermal fentanyl in the management of children with chronic severe pain: results from an international study

Title

Transdermal fentanyl in the management of children with chronic severe pain: results from an international study

Creator

Finkel JC; Finley A; Greco C; Weisman SJ; Zeltzer L

Identifier

Publisher

Cancer

Date

2005

Subject

Child; Female; Humans; Male; Pain; Pain Measurement; Analgesics; Follow-Up Studies; Severity of Illness Index; Risk Assessment; Single-Blind Method; International Cooperation; adolescent; Preschool; Chronic disease; Administration; Dose-Response Relationship; Drug; Opioid/administration & dosage; Cutaneous; Fentanyl/administration & dosage; Intractable/diagnosis/drug therapy; Skin Absorption/drug effects

Description

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.
2005

Rights

Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).

Type

Journal Article

Citation List Month

Backlog

Pages

2847-2857

Issue

12

Volume

104

Citation

Finkel JC; Finley A; Greco C; Weisman SJ; Zeltzer L, “Transdermal fentanyl in the management of children with chronic severe pain: results from an international study,” Pediatric Palliative Care Library, accessed October 21, 2021, https://pedpalascnetlibrary.omeka.net/items/show/13802.

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