Abstract ID: A45
Abstract Title: Patient-controlled Transdermal Fentanyl HCl Analgesia System Versus Intravenous Morphine Patient-controlled Analgesia for the Management of Acute Pain After Gynecologic Surgery
Poster Type: Either
ABSTRACT BODY
Introduction
A fentanyl HCl patient-controlled iontophoretic analgesia delivery system is under development as an alternative to intravenous morphine patient-controlled analgesia (IV PCA) for the short-term management of acute pain, such as that needed following major surgery. This subanalysis of a large-scale study compared the efficacy and safety of these drug delivery modalities for pain management following gynecologic surgery.
Materials and Methods
This study was approved by the institutional review board of each participating center. After initial postoperative pain control was achieved with bolus doses of opioid analgesics, patients were randomized 1:1 to receive the fentanyl HCl patient-controlled transdermal analgesic (PCTA) system or morphine IV PCA. The iontophoretic PCTA system delivered fentanyl HCl 40 ėg on demand, up to 6 doses/hour. IV PCA delivered morphine 1 mg on demand, up to 10 doses/hour. Successful treatment was defined as an excellent or good rating on patient global assessment (PGA) after 24 hours of treatment had been completed. Secondary efficacy endpoints included pain intensity scores, number of doses administered, and withdrawals from the study due to inadequate analgesia.
Results
Of 636 patients undergoing surgery, 275 female patients underwent gynecologic surgery and were included in this subanalysis. 117/138 (85%) of PCTA patients and 115/137 (84%) of IV PCA patients considered their treatment to be a success, rating their pain control as excellent or good on PGA (P=0.848). Pain intensity scores of patients in the PCTA and morphine IV PCA treatment groups were comparable at 4 (32.2 vs 29.1; P=0.274) and 8 hours (29.6 vs. 27.8; P=0.551). Last pain intensity scores (22.9 vs 23.7; P=0.446) and amount of supplemental analgesia required by patients during the first 3 hours of treatment (P=0.524) were not significantly different between treatment groups. Inadequate analgesia resulted in withdrawal of 12 (9%) patients in the PCTA group and 6 (4%) patients in the IV PCA group (P=0.148). The most frequent adverse events in both groups were nausea, headache, pruritus, and vomiting.
Conclusions
Fentanyl HCl PCTA and morphine IV PCA provided similar efficacy and safety for pain management following gynecologic surgery.
Acknowledgement
Research supported by ALZA Corporation, Mountain View, CA.
ATTACHED FILES
Reg Anesth Pain Med 2004; 29(2):A45