XXXX Sublingual Tablet System for the Management of Postoperative Pain after Knee or Hip Arthroplasty: A Randomized, Placebo-controlled Study.

@entity1 @entity390 @entity681 @entity73 @entity111 @entity158
BACKGROUND: Complications with IV @entity1 -controlled analgesia include programming errors, invasive access, and @entity73 . This study evaluated an investigational @entity681 sublingual tablet system (SSTS) for the management of @entity158 after knee or hip arthroplasty. METHODS: This prospective, randomized, parallel-arm, double-blind study randomized postoperative @entity1 at 34   U.S. sites to receive SSTS 15  g (n = 315) or an identical placebo system (n = 104) and @entity158 scores were recorded for up to 72   h. Adult @entity1 with American Society of Anesthesiologists status 1 to 3 after primary total unilateral knee or hip replacement under general anesthesia or with spinal anesthesia that did not include intrathecal opioids were eligible. @entity1 were excluded if they were opioid tolerant. The primary endpoint was the time-weighted summed @entity158 intensity difference to baseline over 48   h. Secondary endpoints included total @entity158 relief, @entity1 and healthcare professional global assessments, and @entity1 and nurse ease-of-care questionnaires. RESULTS: Summed @entity158 intensity difference (standard error) was higher (better) in the SSTS group compared with placebo (76 [7] vs. -11 [11], difference 88 [95% CI, 66 to 109]; P < 0.001). In the SSTS group, more @entity1 and nurses responded "good" or "excellent" on the global assessments compared with placebo (P < 0.001). @entity1 and nurse ease-of-care ratings for the system were high in both groups. There was a higher incidence of @entity390 and @entity111 in the SSTS group. CONCLUSION: SSTS could be an effective @entity1 -controlled @entity158 management modality in @entity1 after major orthopedic surgery and is easy to use by both @entity1 and healthcare professionals.
