Abstract ID: A39

Abstract Title: Comparison of the Safety and Efficacy of the Fentanyl HCl Patient-controlled Transdermal System (Fentanyl HCl PCTS) vs Intravenous Patient-controlled Analgesia (IV PCA) With Morphine Following Total Hip Replacement

Authors: Hartrick C¹, Bourne M², Gargiulo K³, Hewitt D⁴
Royal Oak MI ¹, Salt Lake Orthopaedic Clinic, LifeTree Clinical Research Salt Lake City UT ², Ortho-McNeil Pharmaceutical Inc. Raritan NJ ³, Ortho-McNeil Pharmaceutical Inc. Raritan NJ ⁴
Poster Type: Poster

ABSTRACT BODY

Introduction: Use of intravenous patient-controlled analgesia (IV PCA) with morphine has resulted in improvements to postoperative pain management. Limitations to the use of IV PCA exist, however, particularly for patients undergoing orthopedic surgery. Patients receiving IV PCA must remain attached to an IV line, pole, and PCA pump, which together may limit patient mobility. A novel, self-contained, needle-free, preprogrammed fentanyl HCl patient-controlled transdermal system (fentanyl HCl PCTS; IONSYS™, Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ, USA) has previously been shown to be therapeutically equivalent to morphine IV PCA for the management of moderate-to-severe, acute pain following diverse surgery types (orthopedic, general, and gynecologic). This study compares the safety and efficacy of IONSYS with that of a standard regimen of morphine IV PCA in patients undergoing total hip replacement.

Materials and Methods: This is a multicenter, open-label, randomized, parallel-group, phase IIIb trial of patients who received IONSYS (n=395) or morphine IV PCA (n=404) for up to 72 hours following total hip replacement surgery at 52 sites. Patients were titrated to comfort with IV opioids and then randomized 1:1 to receive IONSYS (40 μ g fentanyl [10-minute infusion/lock-out]; maximum of 6 doses/hour) or morphine IV PCA (1-mg bolus dose [5-minute lock-out period]; maximum of 10 mg/hour). Patients were administered supplemental analgesia (fentanyl or morphine, respectively) as needed during the first 3 hours of treatment. The primary efficacy endpoint was the patient global assessment (PGA) of the method of pain control at 24 hours, in which patients were asked to rate the method of pain control as “excellent,” “good,” “fair,” or “poor.” Success on the PGA was defined as a rating of “good” or “excellent.” Secondary endpoints included the PGA at 48 hours and 72 hours, pain intensity (numerical rating scale, 0–10) at 24 hours, and discontinuation due to inadequate analgesia. Adverse events were also assessed.

Results: The proportions of patients who reported ratings of success on the PGA at 24 hours were equivalent between the IONSYS and morphine IV PCA groups. Mean last pain intensity scores at 24 hours were also equivalent between groups. Slightly more patients in the IONSYS group withdrew from the study due to inadequate analgesia, despite comparable pain intensity scores. Incidence of adverse events was similar between groups, although fewer patients in the IONSYS group withdrew from the study for this reason. Commonly occurring treatment-related adverse events (≥5%) were nausea, vomiting, hypotension, hypoxia, pruritus, dizziness, and application site erythema, all of which occurred more frequently in the IV PCA group, with the exception of dizziness and application site erythema, which occurred more frequently in the IONSYS group.

Conclusion: Findings from this trial demonstrated IONSYS to be comparable in efficacy and safety to morphine IV PCA for the management of acute pain following total hip replacement.

Acknowledgments: Supported by Ortho-McNeil Pharmaceutical, Inc.

ATTACHED FILES

Reg Anesth Pain Med 2005; 30(3):A39