Transdermal fentanyl in children with cancer pain: Feasibility, tolerability, and pharmacokinetic correlates Journal Article

  

Authors:	Collins, J. J.; Dunkel, I. J.; Gupta, S. K.; Inturrisi, C. E.; Lapin, J.; Palmer, L. N.; Weinstein, S. M.; Portenoy, R. K.
Article Title:	Transdermal fentanyl in children with cancer pain: Feasibility, tolerability, and pharmacokinetic correlates
Abstract:	Objectives: (1) To assess the feasibility and tolerability of the therapeutic transdermal fentanyl system (TTS-fentanyl) by using a clinical protocol developed for children with cancer pain. (2) To estimate the pediatric pharmacokinetic parameters of TTS-fentanyl. Methods: The drug was administered in open-label fashion; and measures of analgesia, side effects, and skin changes were obtained for a minimum of 2 doses (6 treatment days). Blood specimens were analyzed for plasma fentanyl concentrations. The pharmacokinetics of TTS-fentanyl were estimated by using a mixed effect modeling approach. Results: Treatment was well tolerated. Ten of the 11 patients who completed the 2 doses continued treatment with TTS-fentanyl. The duration of treatment ranged from 6 to 275 days. The time to reach peak plasma concentration ranged from 18 hours to >66 hours in patients receiving the 25 μg/h patch. Compared with published pharmacokinetic data from adults, the mean clearance and volume of distribution of transdermal fentanyl were the same, but the variability was less. Conclusions: Treatment of children with TTS-fentanyl is feasible and well tolerated and yields fentanyl pharmacokinetic parameter estimates similar to those for adults. A larger study is required to confirm these findings and further test the clinical protocol.
Keywords:	adolescent; child; clinical article; controlled study; school child; treatment outcome; clinical trial; drug tolerability; neoplasms; controlled clinical trial; randomized controlled trial; cancer pain; drug distribution; feasibility studies; drug clearance; drug blood level; analgesics, opioid; pain measurement; pain, intractable; drug formulation; fentanyl; administration, cutaneous; humans; human; priority journal; article; pediatric anesthesia
Journal Title:	Journal of Pediatrics
Volume:	134
Issue:	3
ISSN:	0022-3476
Publisher:	Elsevier Inc.
Date Published:	1999-03-01
Start Page:	319
End Page:	323
Language:	English
PUBMED:	10064669
PROVIDER:	scopus
DOI:	10.1016/S0022-3476(99)70457-9
DOI/URL:	https://www.scopus.com/inward/record.uri?eid=2-s2.0-0033499792&partnerID=40&md5=e865a6839b2770918c43b3a4dd3e2641
Notes:	Article -- Export Date: 16 August 2016 -- Source: Scopus

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