OBJECTIVE: The fentanyl HCl iontophoretic transdermal system (ITS) has effectively managed pain following several types of surgery. This study evaluated the efficacy, safety, and ease of care associated with fentanyl ITS and morphine intravenous patient-controlled analgesia (IV PCA) for pain management following abdominal or pelvic surgery. DESIGN: This open-label, multicenter, randomized, active-controlled, parallel-group, phase IIIb study enrolled 506 postoperative patients at 39 U.S. sites. Patients received fentanyl ITS (40 microg fentanyl/dose) or morphine IV PCA (1 mg morphine/dose). The primary efficacy measure was demonstrating equivalence on the patient global assessment (PGA) of the method of pain control in the first 24 hours of treatment between the groups. RESULTS: Percentages of patients in the fentanyl ITS and morphine IV PCA groups reporting PGA ratings of "good" or "excellent" in the first 24 hours were statistically equivalent (84.9% vs 84.3%, respectively; difference = 0.7%, 95% CI: -5.6% to 7.0%). Equivalence was also demonstrated based on mean last pain intensity scores in the first 24 hours (3.0 vs 2.9, respectively; difference = 0.1, 95% CI: -0.28 to 0.43). Overall discontinuation rates were not significantly different between groups (16.7% vs 11.8%, respectively; P = 0.128). Patients and nurses reported better ease-of-care ratings for fentanyl ITS than for morphine IV PCA. Commonly occurring adverse events were similar between groups. CONCLUSIONS:Fentanyl ITS and morphine IV PCA were comparable methods of pain control following abdominal or pelvic surgery; however, fentanyl ITS was rated better than morphine IV PCA for ease of care by patients and nurses.
RCT Entities:
OBJECTIVE: The fentanyl HCl iontophoretic transdermal system (ITS) has effectively managed pain following several types of surgery. This study evaluated the efficacy, safety, and ease of care associated with fentanyl ITS and morphine intravenous patient-controlled analgesia (IV PCA) for pain management following abdominal or pelvic surgery. DESIGN: This open-label, multicenter, randomized, active-controlled, parallel-group, phase IIIb study enrolled 506 postoperative patients at 39 U.S. sites. Patients received fentanyl ITS (40 microg fentanyl/dose) or morphine IV PCA (1 mg morphine/dose). The primary efficacy measure was demonstrating equivalence on the patient global assessment (PGA) of the method of pain control in the first 24 hours of treatment between the groups. RESULTS: Percentages of patients in the fentanyl ITS and morphine IV PCA groups reporting PGA ratings of "good" or "excellent" in the first 24 hours were statistically equivalent (84.9% vs 84.3%, respectively; difference = 0.7%, 95% CI: -5.6% to 7.0%). Equivalence was also demonstrated based on mean last pain intensity scores in the first 24 hours (3.0 vs 2.9, respectively; difference = 0.1, 95% CI: -0.28 to 0.43). Overall discontinuation rates were not significantly different between groups (16.7% vs 11.8%, respectively; P = 0.128). Patients and nurses reported better ease-of-care ratings for fentanyl ITS than for morphine IV PCA. Commonly occurring adverse events were similar between groups. CONCLUSIONS:Fentanyl ITS and morphine IV PCA were comparable methods of pain control following abdominal or pelvic surgery; however, fentanyl ITS was rated better than morphine IV PCA for ease of care by patients and nurses.