VIENNA, AustriaMore than two thirds of children who have terminal cancer need opioids or other strong analgesics, most commonly oral morphine(Drug information on morphine). Transdermal fentanyl(Drug information on fentanyl) patches (Duragesic) can replace oral morphine in many of these cases and also offer an alternative for patients who cannot take oral drugs, A. Goldman, MD, Institute of Child Health, London, said at the 9th World Congress on Pain.
The investigators enrolled 41 children in this open-label, multicenter study. All were taking at least 30 mg/day of oral morphine at study entry. The children ranged in age from 2 to 18 years (median, 10.5 years), and most had pain due to solid tumors (Table 1).
Patients were transferred to the fentanyl patch using a standard dose-conversion scale (Table 2). Median initial fentanyl patch size was 25 µg/h. Oral morphine was given as needed to control breakthrough pain, and patch size was titrated to achieve pain relief. The trial had a 15-day treatment phase, and patients could opt to continue fentanyl after that.
Pain levels were assessed twice daily by the child and parents using a faces affect scale. Pain relief, side effects, satisfaction, and activity were assessed every 3 days by the child and parents using a play performance scale.
Twenty-six children completed the treatment phase and opted to continue fentanyl. Seven children died of their underlying disease before completing the treatment phase, and eight withdrew. Among these eight children, five stopped fentanyl due to inadequate pain relief.
Of the 26 patients who completed the 15-day treatment phase, 9 (35%) required an increase in fentanyl dose within the first 3 days. Thirteen (50%) required an increase within the first 6 days. Five (19%) required two increases within 6 days. At 15 days, the median patch dose had tripled to 75 µg/h (range, 25 to 250 µg/h).
Dr. Goldman reported, At transfer to fentanyl and at 15 days, children below 10 years of age received significantly higher fentanyl dose per kilogram of body weight (P < .001). Children younger than 10 years also needed significantly more increases in patch size than older children (3 vs 2, P = .049).
The most common side effect was moderate skin erythema, which was observed during 30% of patch changes. There were no serious adverse events attributed to fentanyl and no reports of respiratory depression.
Both children and parents found transdermal fentanyl more convenient than oral morphine, Dr. Goldman said. At 15 days (or upon withdrawal if earlier), 75% of children or parents (27 of the 36 available for evaluation) rated transdermal fentanyl as good or very good.
The investigators concluded that fentanyl patches are effective and convenient for relief of chronic pain in children and may have a slightly better side effect profile than oral morphine. Although convenient, this approach still needs close supervision to ensure appropriate use of breakthrough analgesics and titration of patch size, Dr. Goldman cautioned.
The study was done by investigators at the Institute of Child Health, London; Pediatric Oncology Department, Royal Marsden Hospital, Sutton, UK; Department of Pediatric Hematology/Oncology, Llandough Hospital, Penarth Wales; and Janssen-Cilag, Bucks, UK. Other authors were Drs. A. M. Hunt, J. Baird, T. Devine, and M. B. Phillips.