Abstract

s / Osteoarthritis and Cartilage 21 (2013) S63–S312 S268 bunionectomy with osteotomy and fixation under regional anesthesia. Patients with a pain intensity rating of 40mm on a 100mm Visual Analog Scale (VAS) were randomized to receive indomethacin submicron particle capsules (40mg TID or BID or 20mg TID), celecoxib (400mg loading dose; 200mg BID), or placebo. The primary endpoint was the summed pain intensity difference measured by VAS over 48 hrs (VAS SPID-48). Results: Of the 462 patients enrolled, most (83.1%) were women with a mean age of 41.2 ( 12.5) years. Indomethacin submicron particle capsules 40mg TID (509.6 91.9), 40mg BID (328.0 92.9), and 20mg TID (380.5 92.9) reduced pain (VAS SPID-48; P 0.046 for all 3 groups) compared with placebo (67.8 91.4; Figure). Although there was some evidence of analgesia for celecoxib (279.4 91.9) VAS SPID-48 did not achieve statistical significance compared with placebo. Indomethacin submicron particle capsules 40mg TID (30.7; P1⁄40.013) and 40mg BID (29.8; P1⁄40.014) achieved better pain control over 4 hrs after study entry (VAS SPID-4) compared to placebo (8.9). Similarly, indomethacin submicron particle capsules 40mg TID (2.5; P1⁄40.003) and 40mg BID (2.1; P1⁄40.022) provided greater total pain relief over 4 hrs after study entry (TOTPAR-4) compared with placebo (1.2). Some evidence of pain control was observed as early as 30 min (VAS SPID) in the indomethacin submicron particle capsules 40mg TID (2.9) and 40mg BID (2.6) groups compared with placebo (0.2). AEs were generally similar across treatment groups and included nausea, localized post-procedural edema, dizziness, and headache. ĂConclusions: In this study, investigational lower-dose, indomethacin submicron particle capsules provided effective pain control compared with placebo in a post-surgical model of moderate to severe acute pain. Indomethacin submicron particle capsules are a potentially promising option for patients with acute pain. 520 ACUTE AND SHORT-TERM EFFECTS OF INTRA-ARTICULAR KNEE PAIN RELIEF ON PAIN SENSITIZATION IN KNEE OA: A COHORT STUDY T. Joergensen y, T. Graven-Nielsen z, S. Rosager y, L. Klokker y, K. Ellegaard y, B. Danneskiold-Samsoee y, H. Bliddal y, M. Henriksen y. y The Parker Inst., Dept. of Rheumatology, Copenhagen Univ.

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