Sufentanil Sublingual Tablet System vs. Intravenous Patient-Controlled Analgesia with Morphine for Postoperative Pain Control: A Randomized, Active-Comparator Trial -

Sufentanil Sublingual Tablet System vs. Intravenous Patient-Controlled Analgesia with Morphine for Postoperative Pain Control: A Randomized, Active-Comparator Trial
Information type: Randomised controlled trials
Source: Pain Practice
Specialities: Anaesthesia and pain
Summary
Use of a hand-held system allowing self-dosing with sublingual sufentanil for post-op pain control was non-inferior to morphine IV PCA in terms of the proportion responding ‘good’ or ‘excellent’ on the Patient Global Assessment of method of pain control at 48hrs (78.5% v 65.6%).
UKMi comment
In July 2014, a Marketing Authorisation Application was submitted to the European Medicines Agency seeking approval of sufentanil for the management of moderate to severe acute pain in adult patients in a medically supervised environment. An application was also filed in the US in October 2013; the FDA however recently issued a Complete Response Letter requesting additional information on the Zalviso administration system to ensure proper use of the device.
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