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Arch. Gynecol. Obstet. · Sep 2007
Randomized Controlled Trial Multicenter StudyFentanyl HCl iontophoretic transdermal system versus intravenous morphine pump after gynecologic surgery.
- Shireen Ahmad, David J Hewitt, and C V Damaraju.
- Department of Anesthesiology, Northwestern University Feinberg School of Medicine, 251 E. Huron Street, F5-704, Chicago, IL 60611, USA. sah704@northwestern.edu
- Arch. Gynecol. Obstet. 2007 Sep 1;276(3):251-8.
ObjectiveTo 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.MethodA 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).ResultIn 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.ConclusionThe two modalities were therapeutically equivalent for pain management in these gynecologic surgery patients.
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