Abstract
To compare the efficacy and safety of fentanyl iontophoretic transdermal system (ITS) with morphine intravenous patient-controlled analgesia (IV PCA) for pain management following gynecologic surgery. A subgroup (n = 275) of gynecologic surgery patients from a randomized study (N = 636) of patients treated with fentanyl ITS or morphine IV PCA was analyzed. The main efficacy endpoint was the patient global assessment (PGA) of the method of pain control (first 24 h). In gynecologic surgery patients, PGA success ratings (excellent/good) were statistically equivalent (fentanyl ITS, 84.8%; morphine IV PCA, 83.9%; 95% confidence interval: -7.7%, 9.4%) based on the prespecified equivalence criterion of 10% for the entire study population. Pain intensity at 3 h (P = 0.296), discontinuations due to inadequate analgesia (P = 0.148), and percentages of patients requesting supplemental opioids in the first 3 h (P = 0.524) were similar. The two modalities were therapeutically equivalent for pain management in these gynecologic surgery patients.
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