ArticleClinical drug investigation2021
An Open-Label Study of the Pharmacokinetics and Tolerability of Once-a-Day Fentanyl Citrate Patch in Japanese Pediatric and Adolescent Patients with Cancer Pain.
Article in Clinical drug investigation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed, 3 citations in OpenAlex.
- A Narrative Review of Pain in Pediatric Oncology: The Opioid Option.Paediatric drugs · 2024Review
- Call for Decision Support for High-Alert Medication Administration Among Pediatric Nurses: Findings From a Large, Multicenter, Cross-Sectional Survey in China.Frontiers in pharmacology · 2022Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTransdermal fentanyl is not yet approved for pediatric and adolescent use in Japan.
objectiveSerum fentanyl concentration and the safety and efficacy of once-a-day fentanyl citrate patch were investigated in pediatric and adolescent patients with cancer pain.
methodsIn 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.
resultsEleven 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.
conclusionFentanyl 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.
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