Safety and tolerability of fentanyl iontophoretic transdermal system: findings from a pooled data analysis of four clinical trials

Journal of Opioid Management
Harold MinkowitzRoman J Skowronski

Abstract

Acute postoperative pain remains inadequately managed. Although patient-controlled analgesia (PCA) represents a significant advance in postoperative pain management, drawbacks may include invasiveness and the potential for programming errors. The analysis presented here is based on pooled patient-level safety data from four multicenter, randomized, active-controlled trials that evaluated the safety and tolerability of the needle-free, preprogrammed fentanyl HCl iontophoretic transdermal system (ITS) versus morphine intravenous PCA for postoperative pzin management; the results for patients who received fentanyl ITS are presented here. Adverse events (AEs), serious AEs, and clinically relevant respiratory depression were assessed across patient subpopulations categorized by age. A total of 1288 patients, including 356 elderly (>65 years of age) patients, received fentanyl ITS following surgery. The most commonly reported AEs included nausea, fever, vomiting, headache, anemia, pruritus, and hypotension. The incidence of AEs was generally lower for elderly patients than for patients 65 years or younger. Application-site reactions were reported for 18.6 percent of patients using fentanyl ITS and were generally mild to moderate in s...Continue Reading

Citations

Jan 27, 2016·Expert Opinion on Pharmacotherapy·Andrea FanelliJacques E Chelly
Feb 10, 2012·Gynecological Endocrinology : the Official Journal of the International Society of Gynecological Endocrinology·Mert KüçükMustafa Oğurlu
Jan 21, 2014·Expert Opinion on Pharmacotherapy·Johan Raeder
Mar 13, 2016·Clinical Drug Investigation·Lesley J Scott
Jun 28, 2011·Lancet·Christopher L Wu, Srinivasa N Raja
Jul 19, 2013·The Korean Journal of Pain·Mohamed Amin GhobadifarAmir Hossein Heidarnezhad

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