Abstract ID: A21
Abstract Title: Comparison of the Efficacy and Safety of the Fentanyl Patient-controlled Transdermal System (PCTS) With Morphine Intravenous Patient-controlled Analgesia (PCA) for Acute Postoperative Pain Management Following Abdominal or Pelvic Surgery
Authors: Minkowitz H1, Hewitt D2, Gargiulo K3
Houston TX
Poster Type: Either
ABSTRACT BODY
Introduction:Intravenous patient-controlled analgesia (IV PCA) with morphine is commonly used to treat acute postoperative pain. PCA modalities afford patients the ability to self-initiate analgesia as they need it; however, IV PCA has several drawbacks, including the requirement for patient attachment to IV tubing with a pole and pump apparatus and the risk of medication errors due to device failures and errors in pump programming. A novel, self-contained, needle-free, preprogrammed fentanyl HCl patient-controlled transdermal system (fentanyl HCl PCTS; IONSYS, Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ, USA) is currently under review by the US Food and Drug Administration (FDA) for the management of acute postoperative pain. The herein-described phase IIIb trial compared the efficacy and safety of IONSYS with that of a standard regimen of IV PCA with morphine in patients undergoing abdominal or pelvic surgery.
Materials and Methods:This was a multicenter, open-label, randomized, comparator, parallel-group trial of 501 patients (18 years of age) who underwent abdominal or pelvic surgery at 39 US centers. Following surgery, patients were titrated to comfort with IV opioids and randomized 1:1 to receive either IONSYS (40-mcg fentanyl dose [10-minute infusion]; 6 doses/hour maximum) or a standard regimen of morphine IV PCA (1-mg bolus morphine dose; 5-minute lockout between doses; 10 doses/hour maximum) for up to 72 hours. During the first 3 hours of treatment, patients were provided supplemental analgesia (IV fentanyl or morphine, respectively) upon request. The primary efficacy endpoint was the patient global assessment (PGA) of the method of pain control at 24 hours (4-point scale, 1 = poor,± 2 = fair,¡± 3 = good,± and 4 = excellent±), with success defined as a rating of excellent± or good.± Secondary endpoints included pain intensity (11-point numerical rating scale [0 to 10], 0 = no pain± and 10 = worst possible pain±), and discontinuation due to inadequate analgesia. Adverse events (AEs) were also assessed.
Results:Equivalence on the 24-hour PGA was demonstrated for IONSYS vs morphine IV PCA. PGA scores were also similar between the 2 groups at 48 and 72 hours. Despite demonstrating equivalent pain intensity scores at 24 hours, a higher proportion of patients treated with IONSYS withdrew from the study due to inadequate pain relief compared with morphine IV PCA. Similar proportions of patients withdrew from the study due to AEs between the groups. The most common (Ã5%) treatment-related AEs were nausea, headache, vomiting, pruritus, and application site erythema.
Discussion:Results from this trial demonstrated IONSYS to be therapeutically equivalent to morphine IV PCA, suggesting that this analgesic modality may be a valuable addition to currently available options for postoperative pain management.
Acknowledgments: Ortho-McNeil, Inc.
ATTACHED FILES
Reg Anesth Pain Med 2005; 30(3):A21