Craig S Saffer1, Harold S Minkowitz2, Li Ding3, Hassan Danesi3, James B Jones3. 1. West Coast Ob/Gyn Inc., San Diego, CA 92123, USA. 2. Department of Anesthesiology, Memorial Hermann Memorial City Medical Center, Houston, TX 77024, USA. 3. The Medicines Company, Parsippany, NJ 07054, USA.
Abstract
AIM: To compare the efficacy and safety of patient-controlled fentanyl iontophoretic transdermal system (ITS) with morphine intravenous (i.v.) 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 i.v. 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.
RCT Entities:
AIM: To compare the efficacy and safety of patient-controlled fentanyl iontophoretic transdermal system (ITS) with morphine intravenous (i.v.) 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 i.v. 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.