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INTRODUCTION: Fentanyl iontophoretic transdermal system (ITS) (IONSYS®, The Medicines Company, Parsippany, NJ, USA) and morphine intravenous (IV) patient-controlled analgesia (PCA) have demonstrated equivalent pain control in several published studies. The primary objective of the current study was to compare fentanyl ITS with morphine IV PCA with regard to the patient's ability to mobilise with acute postoperative pain. METHODS: In this multicentre, open-label, randomised, active-controlled, prospective phase IV study, postoperative patients initially received IV morphine and were titrated to pain score ⩽ 4out of 10 on a Numeric Rating Scale (NRS) and then received fentanyl ITS (up to 240 µg (6 doses)/hour; up to a maximum of 3.2 mg (80 doses)/24 hours) or morphine IV PCA (doses up to 20 mg morphine/2 hours, up to 240 mg/24 hours). The primary efficacy measure was ability to mobilise, assessed using patient responses to three validated questions regarding mobility on a 6-point Likert scale (0 = no difficulty to mobilise to 5 = a very great deal of difficulty to mobilise). The study was originally planned to include ~200 patients. However, following the early suspension and termination of the study, a total of 108 patients were randomised to study treatment. RESULTS: One hundred and eight patients were recruited prior to undergoing surgical procedures (orthopaedic surgical procedures (72%) or underwent major abdominal procedures (28%)). Postoperatively, 58 were randomised to receive fentanyl ITS, and 50 to morphine IV PCA. Fentanyl ITS patients had a greater ability to mobilise at the time of stopping study drug, with an adjusted mean ability to mobilise score (95% confidence interval (CI)) of 0.14 (-0.19, 0.47) for fentanyl ITS patients and 2.37 (1.98, 2.76) for morphine IV PCA patients (p < 0.001). CONCLUSION: Patients treated with fentanyl ITS reported that they were better able to mobilise than patients treated with morphine IV PCA, at all time-points following surgery out to 24 hours.
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AIM: To compare the ease-of-care (EOC) examining time efficiency, convenience and satisfaction of fentanyl iontophoretic transdermal system ([ITS] IONSYS®) and morphine intravenous patient-controlled analgesia (iv. PCA) in postoperative pain management using a validated physical therapist (PT) EOC questionnaire. MATERIALS & METHODS: This meta-analysis assessed EOC of fentanyl ITS versus morphine iv. PCA using data from two randomized, active-comparator studies (fentanyl ITS: n = 720 and morphine iv. PCA: n = 739) which used the PT EOC questionnaire (22 items grouped into three subscales; time efficiency, convenience and satisfaction). Each item was scored on a 6-point Likert scale. For time efficiency, PT whose average scores were ≤2 on all items of the time efficiency and convenience subscales or ≥4 on both satisfaction items were considered responders. RESULTS: There were EOC questionnaires from 264 (fentanyl ITS) and 254 (morphine iv. PCA) PTs. There were significantly greater proportions of PTs classified as responders for fentanyl ITS than morphine iv. PCA for overall EOC (81.0 vs 55.7%, respectively), time efficiency (83.1 vs 59.5%, respectively), convenience (87.4 vs 72.0%, respectively) and satisfaction (51.9 vs 30.0%, respectively), all p < 0.0001. CONCLUSION: In this meta-analysis, fentanyl ITS is associated with a superior EOC profile (overall, time efficiency, convenience and satisfaction) from the PTs' perspective when compared with morphine iv. PCA.
