Eiso Hiyama1, Shigeki Yamaguchi2, Koji Okawa3, Fumitaka Hashimoto4, Kuniaki Otaka3, Takaaki Terahara3. 1. Natural Science Center for Basic Research and Development, Hiroshima University, Hiroshima, Japan. 2. Department of Anesthesia and Pain Medicine, Dokkyo Medical University School of Medicine, Tochigi, Japan. 3. Hisamitsu Pharmaceutical Co., Inc., 2-4-1, Marunouchi, Chiyoda-ku, Tokyo, 100-6330, Japan. 4. Hisamitsu Pharmaceutical Co., Inc., 2-4-1, Marunouchi, Chiyoda-ku, Tokyo, 100-6330, Japan. Fumitaka_Hashimoto@hisamitsu.co.jp.
Abstract
BACKGROUND: Transdermal fentanyl is not yet approved for pediatric and adolescent use in Japan. OBJECTIVE: Serum fentanyl concentration and the safety and efficacy of once-a-day fentanyl citrate patch were investigated in pediatric and adolescent patients with cancer pain. METHODS: In this open-label, uncontrolled study, cancer patients aged 2-19 years being treated with strong opioid analgesics were switched to fentanyl citrate patch for 2 weeks. Serum fentanyl concentration was measured at steady state, and severity of pain was evaluated. RESULTS: Eleven patients (four patients aged 2-5 years and seven patients aged 6-19 years) were enrolled. No patient received a dose exceeding 2 mg. Mean serum fentanyl concentrations after administration of 0.5 mg, 1 mg, and 2 mg were 144 pg/mL (n = 4), 277 pg/mL (n = 3), and 2070 pg/mL (n = 4), respectively. All patients were included in the efficacy and safety analysis, but one patient was excluded from the pharmacokinetic analysis because blood was sampled on the day after blood transfusion. A subgroup analysis showed that the mean serum fentanyl concentration tended to be higher in pre-school patients (aged 2-5 years) than in school-aged and adolescent patients (aged 6-19 years) and than in reports of adult patients (aged 20 years and above) who received the same dose. No respiratory adverse events were observed, and pain was well controlled. CONCLUSION: Fentanyl citrate patch tended to result in a higher serum fentanyl concentration in pre-school patients than in school-aged, adolescent, and adult patients who received the same dose. The patch provided adequate pain control, was well tolerated, and did not cause respiratory adverse events. TRIAL REGISTRATION NUMBER: JPRN-JapicCTI-183909.
BACKGROUND: Transdermal fentanyl is not yet approved for pediatric and adolescent use in Japan. OBJECTIVE: Serum fentanyl concentration and the safety and efficacy of once-a-day fentanyl citrate patch were investigated in pediatric and adolescent patients with cancer pain. METHODS: In this open-label, uncontrolled study, cancer patients aged 2-19 years being treated with strong opioid analgesics were switched to fentanyl citrate patch for 2 weeks. Serum fentanyl concentration was measured at steady state, and severity of pain was evaluated. RESULTS: Eleven patients (four patients aged 2-5 years and seven patients aged 6-19 years) were enrolled. No patient received a dose exceeding 2 mg. Mean serum fentanyl concentrations after administration of 0.5 mg, 1 mg, and 2 mg were 144 pg/mL (n = 4), 277 pg/mL (n = 3), and 2070 pg/mL (n = 4), respectively. All patients were included in the efficacy and safety analysis, but one patient was excluded from the pharmacokinetic analysis because blood was sampled on the day after blood transfusion. A subgroup analysis showed that the mean serum fentanyl concentration tended to be higher in pre-school patients (aged 2-5 years) than in school-aged and adolescent patients (aged 6-19 years) and than in reports of adult patients (aged 20 years and above) who received the same dose. No respiratory adverse events were observed, and pain was well controlled. CONCLUSION: Fentanyl citrate patch tended to result in a higher serum fentanyl concentration in pre-school patients than in school-aged, adolescent, and adult patients who received the same dose. The patch provided adequate pain control, was well tolerated, and did not cause respiratory adverse events. TRIAL REGISTRATION NUMBER: JPRN-JapicCTI-183909.