Sublingual sufentanil tablet system for the management of acute postoperative pain in a hospital setting.An observational study

Background: The use of a strong opioid with intravenous patient-controlled analgesia (IV-PCA) is recommended for postoperative pain, but its use is restricted due to technical problems. Other delivery systems, like sublingual PCA, with the sufentanil tablet system (SSTS) device, could overcome the safety concerns related to IV-PCA. Methods: This prospective observational study evaluated the efficacy, safety and usability of SSTS for post-surgical analgesia in the real-life setting. Results: 298 (125 males) subjects, ranging 18-87 years who were undergoing a surgical intervention with a necessity for postoperative analgesia in a hospital setting, were analyzed for SSTS efficacy and safety. The primary end point (success of treatment according to Patient Global Assessment of the Method of Pain Control [PGA] on the second postoperative day) was achieved in 89.8% (95% CI: 85.6-93.1%, p≤0.001 from a presumed value of 60%). During the first 24 hours, pain was below the baseline score (1.2±1.4 after 4 hours and 1.8 ± 1.6 after 20 hours). The mean impairment in quality of sleep was 1.7±1.7 on postoperative day 1. The overall nurse ease of care (EOC) and nurses' satisfaction questionnaire score was 4.6±0.6, and 4.1±0.9, respectively. The overall patient EOC score was 4.3±0.5; 93.5% patients were extremely satisfied/satisfied with pain control and 93.2% were extremely satisfied/satisfied with the way of the administration. Conclusions: Under a real-life clinical practice setting, SSTS provides effective pain management and is easy to use for patients and nurses.