Sufentanil Sublingual Tablet System for the Management of Postoperative Pain Following Open Abdominal Surgery: A Randomized, Placebo-Controlled Study

Administration of opioids to postoperative patients using intravenous patient-controlled analgesia (IV PCA) results in lower pain scores and higher patient satisfaction compared with nurse-administered modalities.1,2 However, the requirement of a patent IV line and tethering of the patient to an IV PCA pump mounted on an IV pole results in risk of infection, reduced mobility, and analgesic gaps due to IV catheter infiltration or IV tubing obstruction.3,4 The programming of the pump, which is required to be completed by the nurse to set up the device, can result in dosing errors.5,6 The sufentanil sublingual tablet system (SSTS; Zalviso; AcelRx Pharmaceuticals, Redwood City, California), currently under review by the FDA, is a preprogrammed, noninvasive patient-activated bedside system to allow patients to manage moderate to severe pain in a hospital setting. The systemic uptake of sublingual sufentanil is rapid because of its high lipophilicity, and the resultant pharmacokinetics demonstrates a blunted peak plasma level and longer plasma half-time than IV administered sufentanil.7 The device has a preprogrammed 20-minute lockout interval and uses a radiofrequency identification (RFID) thumb tag to allow only the patient to operate the device (Fig. ​(Fig.1).1). Upon setup of the system, completed without a need for programming decisions, the nurse inserts a small cartridge containing 40 sufentanil tablets (approximately a 2-day supply) into the dispenser tip, which is then locked into the controller base, and the system is tethered to the bedside or other secure location. The controller base has a graphic user interface screen that facilitates patient training by the nurse and displays setup instructions and system data for authorized health care professionals. Phase 2 dose-finding studies in patients following major surgery demonstrated that sufentanil 15 μg per tablet was the optimal dosage strength, resulting in high patient satisfaction and a similar adverse event profile to lower dosage strengths.7 Sufentanil 15 μg dosed sublingually is equivalent to 3 to 4 mg IV morphine based on 300 to 400 potency factor and 60% bioavailability of sublingual sufentanil. Therefore, this sufentanil dose, available every 20 minutes, reflects an approximately equianalgesic dose to the standard 1 mg morphine on-demand every 6 minutes with typical IV PCA settings. FIGURE 1 Sufentanil sublingual tablet system with RFID patient thumb tag and security tether attached to the bottom of the controller. The objectives of the present study were to evaluate the efficacy and safety of SSTS for the management of postoperative pain in adult patients who had undergone open abdominal surgery. The study hypothesis was that sublingually administered sufentanil using the SSTS device would allow patients to titrate rapidly to acceptable levels of analgesia and would result in a good safety profile and ease of use for both patients and nurses.