Abstract ID: A102

Abstract Title: Occurrence and duration of analgesic gaps as a consequence of system-related events associated with the Fentanyl HCl Patient Activated Transdermal System vs. IV PCA

Authors: Panchal S¹, Damaraju C², Nelson W³, Schein J⁴
COPE Foundation Lutz FL USA¹, Ortho-McNeil Janssen Scientific Affairs, LLC Raritan NJ USA², Applied Health Outcomes Raritan NJ USA³, Ortho-McNeil Janssen Scientific Affairs, LLC Raritan NJ USA⁴
Poster Type: Either

ABSTRACT BODY

Introduction: Intravenous patient-controlled analgesia (IV PCA) is an established and accepted method of postoperative pain management. However, IV PCA set-up, programming, maintenance and troubleshooting can be complex and time consuming, and may lead to analgesic gaps (time periods when patient does not have immediate access to analgesia) and excess resource utilization such as nursing time.
Materials and Methods: Two clinical trials were recently completed that compared the safety and efficacy of patient controlled analgesia delivered by fentanyl HCl Patient Activated Transdermal (PATS) system versus morphine IV pump after primary unilateral total hip replacement and lower abdominal or pelvic surgery for post-operative pain management. In addition to clinical data, the trials were also designed to collect data on the types and frequencies of system-related events that have historically led to analgesic gaps.
Results: A total of 647 patients on fentanyl HCl PATS and 658 patients on IV PCA participated in the studies. A greater proportion of subjects on IV PCA (n = 79, 12.0%) suffered an analgesic gap as a result of a system-related event compared to fentanyl HCl PATS (n = 38, 5.9%) (p < 0.001). Among those who experienced a system-related event (outliers excluded), the mean total analgesic gap was 6.3 ą 13.8 (s.d.) minutes for patients on fentanyl HCl PATS and 11.2 ą 16.0 minutes for patients on IV PCA. The mean total time required to resolve the system-related events was 13.5 ą 18.7 minutes for patients on fentanyl HCl PATS and 20.4 ą 19.7 minutes for patients on IV PCA. Overall, patients on IV PCA experienced a wide range of events (e.g., infiltration, IV line pulled out), requiring invasive interventions, such as starting a new IV line. In contrast, the primary event suffered by patients on fentanyl HCl PATS was device malfunction/failure usually related to the red light and beeping of the device, which was intervened by topical re-application of a new system.
Discussion: Compared with IV PCA, fentanyl HCl PATS was associated with fewer and shorter analgesic gaps, and less time was required to resolve system-related events in a clinical trial setting. These data suggest that fentanyl HCl PATS may be associated with fewer analgesic treatment interruptions postoperatively, while simultaneously consuming fewer resources.

ATTACHED FILES

Reg Anesth Pain Med 2005; 30(3):A102