Fentanyl iontophoretic transdermal system versus morphine intravenous patient-controlled analgesia for pain management following gynecological surgery: a meta-analysis of randomized, controlled trials

Abstract

SUMMARY  Aim: To compare the efficacy and safety of patient-controlled fentanyl iontophoretic transdermal system (ITS) with morphine intravenous (iv.) patient-controlled analgesia (PCA) for pain management following gynecological surgery. Methods: Two-open-label, multicenter, randomized, active-controlled, parallel-group studies (n = 1142) were conducted that compared fentanyl ITS with morphine iv. PCA for postoperative pain. The subgroup of gynecological surgery patients from each trial was utilized for this meta-analysis (n = 604). Of these patients, 295 received fentanyl ITS (40 μg/dose) and 309 received morphine iv. PCA (1 mg/dose) for up to 72 h. Efficacy measures included the patient global assessment (PGA) and the investigator global assessment (IGA) of the method of pain control. Results: Gynecological surgery patients (n = 604) included in this meta-analysis had a mean age of 45 years, were predominantly Caucasian (65%) and had a mean body mass index of 29 mg/kg2. There were statistically significantly more patients treated with fentanyl ITS and more investigators who rated their pain control method as ‘excellent’ on the PGA at 24 h (49.3 vs 37.4%, respectively; p = 0.0029) and IGA at the last assessment (59.5 vs 38.0%, respectively; p < 0.0001), respectively, compared with morphine iv. PCA at the last assessment. Conclusion: Following gynecological surgery, patients and investigators were more satisfied (had a higher percent of an ‘excellent’ rating on the PGA and IGA, respectively) with fentanyl ITS than morphine iv. PCA as a method of pain control.