Iontophoretic transdermal system using fentanyl compared with patient-controlled intravenous analgesia using morphine for postoperative pain management

Background: The fentanyl iontophoretic transdermal system (fentanyl ITS)enables needle-free, patient-controlled analgesia for postoperativepain management. This study compared the efficacy, safety, andease of care of fentanyl ITS with patient-controlled, i.v. analgesia(PCIA) with morphine for postoperative pain management. Methods: A prospective, randomized, multicentre trial enrolled patientsin Europe after abdominal or orthopaedic surgery. Patients receivedfentanyl ITS (n = 325; 40.0 µg fentanyl over 10 min) ormorphine PCIA [n = 335; bolus doses (standard at each hospital)]for 72 h. Supplemental i.v. morphine was available during thefirst 3 h. The primary efficacy measure was the patient globalassessment (PGA) of the pain control method during the first24 h. Results: PGA ratings of ‘good’ or ‘excellent’were reported by 86.2 and 87.5% of patients using fentanyl ITSor morphine PCIA, respectively (95% CI, –6.5 to 3.9%).Mean (SD) last pain intensity scores (numerical rating scale,0–10) were 1.8 (1.77) and 1.9 (1.86) in the fentanyl ITSand morphine PCIA groups, respectively (95% CI, –0.38to 0.18). More patients reported a system-related problem forfentanyl ITS than morphine PCIA (51.1 vs 17.9%, respectively).However, fewer of these problems interrupted pain control (4.4vs 41.3%, respectively). Patients, nurses, and physiotherapistsreported more favourable overall ease-of-care ratings for fentanylITS than morphine PCIA. Study termination rates and opioid-relatedside-effects were similar between groups. Conclusion: Fentanyl ITS and morphine PCIA were comparably effective andsafe.