Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Abstract Title: A Phase 2 Open-Label Functionality, Safety, and Efficacy Study of the Sufentanil NanoTab™ PCA System in Patients Following Elective Unilateral Knee Replacement Surgery Authors: David Griffin, MD, Vero Beach, FL Roman Skowronski, MD, PhD, Redwood City, CA; Pamela Palmer, MD, PhD, Redwood City, CA Introduction: Intravenous patient-controlled analgesia (IV PCA) with morphine is the standard of care in many hospitals for the management of acute post-operative pain. However, IV PCA is associated with several limitations, including, the risk of PCA pump programming errors, reduced patient mobility secondary to the requisite IV line, and increased risk of analgesic gaps due to infiltrated and dislodged IV catheters or pump malfunction. Furthermore, while morphine is the most commonly used analgesic in this treatment modality, it can produce many undesirable side effects due to accumulation of active metabolites, especially in elderly and renally impaired patients. The Sufentanil NanoTab PCA System is a novel patient-controlled sublingual analgesia (PCSA) product candidate with a pre-programmed patient lock-out feature that is designed for use in hospital settings to provide effective, titratable, patient-controlled analgesia and reduce the risk of programming errors. The Sufentanil NanoTab PCA System also avoids the IV-related limitations of IV PCA by being designed to provide convenient and safe patient self-administration of Sufentanil NanoTabs sublingually for oral transmucosal absorption. Methods: This multicenter, open-label study enrolled 30 patients (mean age 65.7; range 51-78) following elective unilateral knee replacement surgery. Nineteen patients (63.3%) were at least 65 years old. Patients self-administered 15 mcg doses of Sufentanil NanoTabs sublingually as needed using the handheld Sufentanil NanoTab PCA System with a minimal re-dosing interval of 20 minutes. The primary efficacy endpoint was device functionality assessed as the proportion of patients who successfully completed the study without any type of System failure. Results: All enrolled patients (100%) completed the study without System failures or dosing errors of any kind, which included over 375 dispensed NanoTabs. Twenty-five patients (83.3%) reported the two highest scores on the 5-point Likert scale of overall patient’s satisfaction with the System. All 30 enrolled patients indicated that they could handle the system easily and their user instructions were clear. All 30 enrolled patients indicated that the dosing tone was sufficiently loud and that the time required for dosing was just right. Twenty-seven patients (90%) indicated that the size and the shape of the dosing tip was just right. The majority of patients indicated that the other system features (weight, size, shape, and dose button function) were acceptable. The mean pain intensity difference (PID) scores increased from 0.3 at 15 minutes to 2.4 at 3 hours. After 3 hours, the mean PID were variable and ranged from 1.3 to 2.0. Nineteen (63.3%) and 24 patients (80%) responded very good or excellent on the patient global evaluation of pain relief and global evaluation of tolerability, respectively. The most common related adverse events (AEs) were vomiting (6 patients, 20.0%) and nausea (5 patients, 16.7%). All events were mild or moderate in severity; no severe AEs were reported during the study. There were no serious AEs (SAEs) during the study drug treatment or 12-hours after the end-of-treatment. One patient discontinued study drug due to an AE of moderate anxiety that was judged as not related to study drug. There were no reports of oral mucosa irritation. Conclusions: The results of this Phase 2 study confirm the functionality, safety and efficacy of the Sufentanil NanoTab PCA System in management of acute moderate-to-severe post-operative pain following knee replacement surgery. Future Phase 3 studies of the Sufentanil NanoTab PCA System will further delineate the safety and efficacy of this PCSA system. Reg Anesth Pain Med 2010; 7