Background and Objectives: The fentanyl HCl iontophoretic transdermal system (ITS) has been demonstrated in clinical trials to be safe and effective for acute-pain management after several types of major surgery. The current study compared the efficacy, safety, and convenience of fentanyl ITS with morphine intravenous patient-controlled analgesia (IV PCA) for acute-pain management after unilateral total-hip replacement (THR).
Methods: In this multicenter (52 sites), randomized, open-label, active-controlled, phase IIIb study, patients (n = 799) received fentanyl ITS (40 μg fentanyl [10-minute infusion/lockout], up to 6 doses/h) or morphine IV PCA (1-mg morphine bolus [5-minute lockout], up to 10 mg/h) after unilateral THR. The primary efficacy measure was success ratings (“excellent” or “good”) on the patient global assessment (PGA) of the method of pain control in the first 24 hours. Pain intensity and adverse events were also assessed.
Results: The PGA success ratings (83.0% v 82.2%; difference = 0.9%; 95% CI: −4.4% to 6.1%) and the mean last pain-intensity scores (3.0 v 3.0; difference = 0.0; 95% CI: −0.33 to 0.33) in the first 24 hours were statistically equivalent between fentanyl ITS and morphine IV PCA groups, respectively. The incidence of adverse events was similar between the groups.
Conclusions: Results of this study demonstrate fentanyl ITS and a standard regimen of morphine IV PCA were comparable methods of pain control for management of acute postoperative pain after THR, on the basis of the PGA success ratings and pain intensity in the first 24 hours of treatment.
- Acute-pain management
- Multimodal therapy
- Patient-controlled analgesia
- Total-hip replacement
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Ortho-McNeil, Inc., Raritan, NJ, funded the study. Dr. Hartrick has received research support for this study and partial reimbursement for travel expenses incurred in presenting these data at scientific meetings from Ortho-McNeil, Inc. Dr. Hartrick and Dr. Bourne have subsequently served as consultants in the development of ongoing projects with Ortho-McNeil, Inc.
All authors contributed to the design of the study and development of the manuscript and had full editorial control over the content. This study was conducted at 52 sites, which are listed, along with the name of the principal investigator at each site, in the Appendix.
Results of this study have been presented at the International Association for the Study of Pain (IASP) 11th World Congress on Pain, August 21-26, 2005, Sydney, Australia; the Annual Fall Pain Meeting and Workshops of the American Society of Regional Anesthesia and Pain Medicine, November 17-20, 2005, Miami Beach, FL; and the Postgraduate Assembly in Anesthesiology of the New York State Society of Anesthesiologists, December 9-13, 2005, New York, NY.