Sufentanil sublingual tablet system for the management of postoperative pain following open abdominal surgery: a randomized, placebo-controlled study.

"H.S.M. received honoraria and research funding; F.G.R., T.J.G., and K.A.A. have received research funding; Y.C. is a paid consultant and M.A.E. and P.P.P. are employees of AcelRx."

"Funding was received from AcelRx Pharmaceuticals, Redwood City, CA."

"This phase 3, randomized, placebo-controlled, double-blind study was conducted at 13 hospitals in the United States between March 2012 and January 2013 (clinicaltrials.gov; NCT01539642). The study protocol and statement of informed consent were approved by a centralized institutional review board (Copernicus Group, Research Triangle Park, North Carolina) or the local institutional review board at each study site. All patients provided written informed consent before undergoing any study procedures. Male and nonpregnant female patients were eligible for inclusion if they were at least 18 years old, American Society of Anesthesiologists physical status I to III, and scheduled to undergo open abdominal surgery (including open abdominal surgeries that were laparoscopic assisted, such as partial colectomies) under general anesthesia or spinal anesthesia that did not include intrathecal opioids. Fully laparoscopic surgeries were not included. Patients were excluded if they were opioid tolerant (use of >15 mg oral morphine equivalent per day within the past 3 months); had documented sleep apnea, alcohol or drug abuse, or a need for outpatient oxygen therapy; or had any medical condition that would interfere with pain assessments. The use of any drug that may affect postoperative pain levels, such as gabapentanoids, steroids, or anti-inflammatory drugs were not allowed intraoperatively or postoperatively. Therefore, patients with a chronic pain condition necessitating treatment with these agents were also excluded from the study."