Fentanyl iontophoretic transdermal system versus morphine intravenous patient-controlled analgesia for pain management following orthopedic surgery: A pooled analysis of randomized, controlled trials.

Objective: To compare the efficacy and safety of patient-controlled pain management following orthopedic surgery using either fentanyl iontophoretic transdermal system (ITS) or morphine intravenous (i.v.) patient-controlled analgesia (PCA).

Setting: Acute Care Hospital.

Patients: Three-open-label, multicenter, randomized, active-controlled, parallel-group phase 3B studies (N = 2095) were conducted that compared fentanyl ITS with morphine i.v. PCA for postoperative pain in hospitalized postoperative patients. A subgroup of orthopedic surgery patients (N = 1,216) was pooled for this analysis; of which 819 completed treatment.

Interventions: A total of 590 patients received fentanyl ITS (40 µg/dose) and 626 patients received morphine i.v. PCA (1 mg/dose) for up to 72 hours.

Main Outcome Measures: Efficacy measures included the patient global assessment (PGA) and the investigator global assessment (IGA) of the method of pain control.

Results: Patients had a mean age of about 60 years, were predominantly Caucasian (90.5 percent), and the majority underwent hip replacement (80.3 percent). There were more patients treated with fentanyl ITS who rated their pain control method as "excellent" compared to morphine i.v. PCA at 24 hours postsurgery (44.8 percent vs 33.0 percent, respectively; p < 0.001), 48 hours (37.5 percent vs 25.3 percent, respectively; p < 0.001), and at the last assessment (54.3 percent vs 39.6 percent, respectively; p < 0.001). There were more investigators who rated treatment with fentanyl ITS as "excellent" compared to morphine i.v. PCA at the last assessment (57.4 percent vs 36.9 percent, respectively; p < 0.001).

Conclusions: Following orthopedic surgery, patients and investigators more frequently reported global assessment of pain control as "excellent" on the PGA and IGA assessments with fentanyl ITS than with morphine i.v. PCA.