Maurice Jove1, David W Griffin, Harold S Minkowitz, Bruce Ben-David, Mark A Evashenk, Pamela P Palmer. 1. From the Department of Orthopedics, DeKalb Medical Center, Decatur, Georgia (M.J.); Department of Orthopedics, Indian River Medical Center, Vero Beach, Florida (D.W.G.); Department of Anesthesia, Memorial Hermann Memorial City Hospital Medical Center, Houston, Texas (H.S.M.); Department of Anesthesia, University of Pittsburgh Medical Center-Presbyterian Shadyside, Pittsburgh, Pennsylvania (B.B.-D.); and AcelRx Pharmaceuticals, Redwood City, California (M.A.E., P.P.P.).
Abstract
BACKGROUND: Complications with IV patient-controlled analgesia include programming errors, invasive access, and impairment of mobility. This study evaluated an investigational sufentanil sublingual tablet system (SSTS) for the management of pain after knee or hip arthroplasty. METHODS: This prospective, randomized, parallel-arm, double-blind study randomized postoperative patients at 34 U.S. sites to receive SSTS 15 μg (n = 315) or anidentical placebo system (n = 104) and pain scores were recorded for up to 72 h. Adult patients with American Society of Anesthesiologists status 1 to 3 after primary totalunilateral knee or hip replacement under general anesthesia or with spinal anesthesia that did not include intrathecal opioids were eligible. Patients were excluded if they were opioid tolerant. The primary endpoint was the time-weighted summed pain intensity difference to baseline over 48 h. Secondary endpoints included total pain relief, patient and healthcare professional global assessments, and patient and nurse ease-of-care questionnaires. RESULTS:Summed pain 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 patients and nurses responded "good" or "excellent" on the global assessments compared with placebo (P < 0.001). Patient and nurse ease-of-care ratings for the system were high in both groups. There was a higher incidence of nausea and pruritus in the SSTS group. CONCLUSION: SSTS could be an effective patient-controlled pain management modality in patients after major orthopedic surgery and is easy to use by both patients and healthcare professionals.
RCT Entities:
BACKGROUND: Complications with IV patient-controlled analgesia include programming errors, invasive access, and impairment of mobility. This study evaluated an investigational sufentanil sublingual tablet system (SSTS) for the management of pain after knee or hip arthroplasty. METHODS: This prospective, randomized, parallel-arm, double-blind study randomized postoperative patients at 34 U.S. sites to receive SSTS 15 μg (n = 315) or an identical placebo system (n = 104) and pain scores were recorded for up to 72 h. Adult patients 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. Patients were excluded if they were opioid tolerant. The primary endpoint was the time-weighted summed pain intensity difference to baseline over 48 h. Secondary endpoints included total pain relief, patient and healthcare professional global assessments, and patient and nurse ease-of-care questionnaires. RESULTS: Summed pain 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 patients and nurses responded "good" or "excellent" on the global assessments compared with placebo (P < 0.001). Patient and nurse ease-of-care ratings for the system were high in both groups. There was a higher incidence of nausea and pruritus in the SSTS group. CONCLUSION: SSTS could be an effective patient-controlled pain management modality in patients after major orthopedic surgery and is easy to use by both patients and healthcare professionals.
Authors: R Likar; W Jaksch; T Aigmüller; M Brunner; T Cohnert; J Dieber; W Eisner; S Geyrhofer; G Grögl; F Herbst; R Hetterle; F Javorsky; H G Kress; O Kwasny; S Madersbacher; H Mächler; R Mittermair; J Osterbrink; B Stöckl; M Sulzbacher; B Taxer; B Todoroff; A Tuchmann; A Wicker; A Sandner-Kiesling Journal: Schmerz Date: 2017-10 Impact factor: 1.107
Authors: Jacob L Hutchins; David Leiman; Harold S Minkowitz; Maurice Jove; Karen P DiDonato; Pamela P Palmer Journal: Pain Med Date: 2018-10-01 Impact factor: 3.750