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PAIN MEDICINE

An Iontophoretic Fentanyl Patient-Activated Analgesic Delivery System for Postoperative Pain: A Double-Blind, Placebo-Controlled Trial

Eugene R. Viscusi, MD^*, Lowell Reynolds, MD, Stacy Tait, MD, Timothy Melson, MD, and Linda E. Atkinson, PhD^||

*Department of Anesthesiology, Jefferson Medical College, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania; Department of Anesthesiology, Loma Linda University School of Medicine, Loma Linda, California; Department of Anesthesiology, Sparks Regional Medical Center, Fort Smith, Arkansas; Department of Anesthesia, Helen Keller Hospital, Sheffield, Alabama; and ||Clinical Development, ALZA Corporation, Mountain View, California

Address correspondence and reprint requests to Eugene R. Viscusi, MD, Department of Anesthesiology, Thomas Jefferson University, 111 South 11th St., Suite G 8490, Philadelphia, PA 19107. Address e-mail to eugene.viscusi{at}jefferson.edu.

An iontophoretic fentanyl HCl patient-activated transdermal system (fentanyl HCl PATS) is under development for the treatment of acute postoperative pain. The fentanyl HCl PATS is a needle-free, credit card-sized, preprogrammed system that is applied to the patient's upper outer arm or chest. The fentanyl HCl PATS was demonstrated to be superior to placebo in a previous trial; however, the randomization scheme used and the lack of control of entry pain level may have contributed to the lack of robust findings. We compared the fentanyl HCl PATS with placebo for acute postoperative pain management in a larger trial that addressed the limitations of the previous study. Adult patients admitted to the postanesthesia care unit after major surgery were titrated to comfort with opioids and randomized 1:1 to receive the fentanyl HCl PATS 40 µg or placebo for 24 hours. Supplemental IV fentanyl was available to patients upon request in both treatment groups for the first 3 hours after enrollment. The primary efficacy end-point was the percentage of patients who discontinued participation in the study because of inadequate analgesia. Pain intensity scores, patient global assessments (PGA), and investigator global assessments (IGA) were collected. Four-hundred-eighty-four patients (PATS, n = 244; placebo, n = 240) were enrolled. Fewer patients receiving the fentanyl HCl PATS discontinued because of inadequate analgesia compared with placebo (28.7% versus 60.0%; P < 0.0001). Mean last pain intensity scores were 3.5 and 5.4 for the fentanyl HCl PATS and placebo groups, respectively. Patients (73.4%, PGA) and investigators (72.1%, IGA) considered the fentanyl HCl PATS a good or excellent method of pain control. Treatment-related adverse events were similar between groups. This study demonstrated the superiority of the iontophoretic fentanyl HCl PATS over placebo for acute postoperative pain management.

This article has been cited by other articles:

				E. R. Viscusi, M. Siccardi, C. V. Damaraju, D. J. Hewitt, and P. Kershaw The Safety and Efficacy of Fentanyl Iontophoretic Transdermal System Compared with Morphine Intravenous Patient-Controlled Analgesia for Postoperative Pain Management: An Analysis of Pooled Data from Three Randomized, Active-Controlled Clinical Studies Anesth. Analg., November 1, 2007; 105(5): 1428 - 1436. [Abstract] [Full Text] [PDF]

				S. J. Panchal, C. V. Damaraju, W. W. Nelson, D. J. Hewitt, and J. R. Schein System-Related Events and Analgesic Gaps During Postoperative Pain Management with the Fentanyl Iontophoretic Transdermal System and Morphine Intravenous Patient-Controlled Analgesia Anesth. Analg., November 1, 2007; 105(5): 1437 - 1441. [Abstract] [Full Text] [PDF]

				S. Grond, J. Hall, A. Spacek, M. Hoppenbrouwers, U. Richarz, and F. Bonnet Iontophoretic transdermal system using fentanyl compared with patient-controlled intravenous analgesia using morphine for postoperative pain management Br. J. Anaesth., June 1, 2007; 98(6): 806 - 815. [Abstract] [Full Text] [PDF]

				I. Power Fentanyl HCl iontophoretic transdermal system (ITS): clinical application of iontophoretic technology in the management of acute postoperative pain Br. J. Anaesth., January 1, 2007; 98(1): 4 - 11. [Abstract] [Full Text] [PDF]

				S. Mayes and M. Ferrone Fentanyl HCl Patient-Controlled Iontophoretic Transdermal System for the Management of Acute Postoperative Pain Ann. Pharmacother., December 1, 2006; 40(12): 2178 - 2186. [Abstract] [Full Text] [PDF]

Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999