Comparison of fentanyl iontophoretic transdermal system and routine care with morphine intravenous patient-controlled analgesia in the management of early postoperative mobilisation: results from a randomised study

Abstract

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.

Can Multimodal Pain Management in TKA Eliminate Patient-controlled Analgesia and Femoral Nerve Blocks?

“…PCA use also has unwanted associated complications including ORAEs and delays in rehabilitation. Langford et al [16] demonstrated that PCA use versus an alternative fentanyl transdermal delivery poses delays in early rehabilitation.…”

“…However, these protocols vary widely between institutions with no current consensus on a standardized regimen. Preemptive analgesia [9], peripheral anesthesia techniques such as femoral nerve block (FNB) or adductor canal blocks [2], intraoperative periarticular injections (PAIs) [12] with mixed drug regimens or liposomal bupivacaine [3], patient-controlled analgesia (PCA), and oral narcotics [16,18] have all been part of reported regimens.…”

Non-invasive patient-controlled analgesia in the management of acute postoperative pain in the hospital setting

“…A multicenter, randomized open-label, phase IV clinical trial has also recently demonstrated that, at all time-points following surgery out to 24 hours, patients treated with the FITS were better able to mobilize than patients treated with IV morphine PCA 83 . Although the study was stopped and treatment terminated earlier than planned, patients in the FITS group (n ¼ 58) had a greater ability than those in the IV morphine PCA group (n ¼ 50) to mobilize at the time of stopping the study drug, with an adjusted mean ability to mobilize score (95% confidence intervals [CI] 0.14 (-0.19, 0.47) and 2.37 (1.98, 2.76) for the FITS and IV morphine PCA, respectively; p < .001) 83 .…”

Adherencia a principios del manejo del dolor establecidos por la OMS en cirugía mayor electiva.

“…Para poder valorar la severidad del dolor en el posoperatorio, se debe tener en consideración el grado de la cirugía (menor, intermedia y mayor) 4 y la intensidad del dolor mediante una escala de medición 6,[16][17][18][19][20] . El manejo del dolor inadecuado es una de las condiciones de los países en desarrollo 4 .…”