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 fentanylITS 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 fentanylITS (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. RESULTS:PGA ratings of 'good' or 'excellent' were reported by 86.2 and 87.5% of patients using fentanylITS 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 fentanylITS 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 fentanylITS 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.
RCT Entities:
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 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. 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.
Authors: R Likar; W Jaksch; T Aigmüller; M Brunner; T Cohnert; J Dieber; W Eisner; S Geyrhofer; G Grögl; F Herbst; R Hetterle; F Javorsky; H G Kress; O Kwasny; S Madersbacher; H Mächler; R Mittermair; J Osterbrink; B Stöckl; M Sulzbacher; B Taxer; B Todoroff; A Tuchmann; A Wicker; A Sandner-Kiesling Journal: Schmerz Date: 2017-10 Impact factor: 1.107