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

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...

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Published in:British journal of anaesthesia : BJA Vol. 98; no. 6; pp. 806 - 815
Main Authors: Grond, S., Hall, J., Spacek, A., Hoppenbrouwers, M., Richarz, U., Bonnet, F.
Format: Journal Article
Language:English
Published: Oxford Elsevier Ltd 01-06-2007
Oxford University Press
Oxford Publishing Limited (England)
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Summary: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. 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. 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. Fentanyl ITS and morphine PCIA were comparably effective and safe.
Bibliography:ArticleID:aem102
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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ISSN:0007-0912
1471-6771
DOI:10.1093/bja/aem102