• Br J Anaesth · Jun 2007

    Randomized Controlled Trial Multicenter Study

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

    • S Grond, J Hall, A Spacek, M Hoppenbrouwers, U Richarz, and F Bonnet.
    • Klinik für Anästhesiologie, Martin-Luther-Universität Halle-Wittenberg, Halle, Germany. stefan.grond@Medizin.Uni-Halle.de
    • Br J Anaesth. 2007 Jun 1;98(6):806-15.

    BackgroundThe fentanyl iontophoretic transdermal system (fentanyl ITS) enables needle-free, patient-controlled analgesia for postoperative pain management. This study compared the efficacy, safety, and ease of care of fentanyl ITS with patient-controlled, i.v. analgesia (PCIA) with morphine for postoperative pain management.MethodsA prospective, randomized, multicentre trial enrolled patients in Europe after abdominal or orthopaedic surgery. Patients received fentanyl ITS (n = 325; 40.0 microg fentanyl over 10 min) or morphine PCIA [n = 335; bolus doses (standard at each hospital)] for < or =72 h. Supplemental i.v. morphine was available during the first 3 h. The primary efficacy measure was the patient global assessment (PGA) of the pain control method during the first 24 h.ResultsPGA ratings of 'good' or 'excellent' were reported by 86.2 and 87.5% of patients using fentanyl ITS or 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 ITS and morphine PCIA groups, respectively (95% CI, -0.38 to 0.18). More patients reported a system-related problem for fentanyl ITS than morphine PCIA (51.1 vs 17.9%, respectively). However, fewer of these problems interrupted pain control (4.4 vs 41.3%, respectively). Patients, nurses, and physiotherapists reported more favourable overall ease-of-care ratings for fentanyl ITS than morphine PCIA. Study termination rates and opioid-related side-effects were similar between groups.ConclusionFentanyl ITS and morphine PCIA were comparably effective and safe.

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