Iontophoretic transdermal system using fentanyl compared with patient-controlled intravenous analgesia using morphine for postoperative pain management
1 Klinik für Anästhesiologie, Martin-Luther-Universität Halle-Wittenberg, Halle, Germany
2 Anaesthetics and Intensive Care Medicine, Heath Park, Cardiff, UK
3 Klinik für Anästhesie und Allgemeine Intensivmedizin, Medizinische Universität Wien, Wien, Austria
4 SGS Medisearch International, Mechelen, Belgium
5 Janssen-Cilag EMEA, Baar, Switzerland
6 Département d'Anesthésie—Réanimation, Hôpital Tenon, Assistance Publique Hôpitaux de Paris, Université Paris VI, Paris, France
* Corresponding author: Klinik für Anästhesiologie, Martin-Luther-Universität Halle-Wittenberg, Ernst-Grube-Str. 40, 06097 Halle, Germany. E-mail: stefan.grond{at}Medizin.Uni-Halle.de
Background: The 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.
Methods: A prospective, randomized, multicentre trial enrolled patients in Europe after abdominal or orthopaedic surgery. Patients received fentanyl ITS (n = 325; 40.0 µg fentanyl over 10 min) or morphine PCIA [n = 335; bolus doses (standard at each hospital)] for 
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.
Results: PGA 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.
Conclusion: Fentanyl ITS and morphine PCIA were comparably effective and safe.
Keywords: analgesia, patient-controlled; analgesia, postoperative; analgesics opioid, fentanyl; analgesics opioid, morphine; analgesic techniques, transdermal iontophoresis
Declaration of interest. Stefan Grond received honoraria from Janssen-Cilag for providing lectures and participating in an advisory board. Judith Hall received an honorarium from Janssen-Cilag for providing a lecture. Anna Spacek received honoraria from Janssen-Cilag for providing lectures and participating in an advisory board and received travel reimbursement from Janssen-Cilag to speak at a scientific conference. Mieke Hoppenbrouwers worked as a biostatistician in the contract research organization that oversaw the biometrics of the trial. Ute Richarz is an employee of Janssen-Cilag. Francis Bonnet was funded as a consultant for Janssen-Cilag in 2006.
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