Sublingual sufentanil for postoperative pain relief: first clinical experiences

Abstract

Background: The sublingual sufentanil tablet system (SSTS) is a novel hand-held patient-controlled analgesia device developed for treatment of moderate-to-severe postoperative pain. Here we present the first results of its clinical use.

Methods: Adult patients undergoing major surgery in five hospitals in the Netherlands received the SSTS for postoperative pain relief as part of multimodal pain management that further included paracetamol and a nonsteroidal anti-inflammatory drug (NSAID). The following variables were collected: postoperative pain scores using the 11-point numerical rating score (NRS) at rest, number of tablets used, occurrence of nausea, and patient satisfaction scores.

Results: We included 280 patients in the study; the majority underwent laparoscopic abdominal (49%) or orthopedic (knee replacement) surgery (34%). The median NRS was 3.5 (interquartile range 2.3-4.0) on the day of surgery, 3.3 (2.3-4.0) on the first postoperative day, and 2.8 (2.0-4.0) on the second postoperative day; pain scores did not differ between surgery types. Mean number of tablets used was 19 (range 0-86). Nausea occurred in 34% of patients, more often in women (45% vs 19%). Overall satisfaction was high in 73% of patients. Satisfaction was correlated with pain relief (p<0.001) and inversely correlated with occurrence of nausea (p=0.01).

Discussion: In this data set obtained under real-life conditions we show that the SSTS effectively managed postoperative pain in abdominal and orthopedic surgeries. Future studies should determine patient populations that benefit most from the SSTS, assess the added values versus intravenous patient-controlled analgesia, and determine the pharmacoeconomics of the system.

Keywords: acute pain; opioid; postoperative pain; sublingual formulation; sufentanil.

Figure 1

Box plots of pain scores upon arrival in the post-anesthesia care unit (only the data from patients after general anesthesia were used), and pain scores of all patients observed during day 0 (day of surgery) and days 1 and 2 after surgery. Note: Pain scores were obtained three times per day and the daily averages were used for analysis. Abbreviation: PACU, post-anesthesia care unit; SSTS, sublingual sufentanil tablet system.

Figure 2

Pie charts of satisfaction scores of patients treated with the sublingual sufentanil tablet system. Notes: Panel (A) depicts all patients, panel (B) patients following abdominal surgery, and panel (C) patients following orthopedic surgery.