Comparison of Valdecoxib and an oxycodone-acetaminophen combination for acute musculoskeletal pain in the emergency department: A randomized controlled trial

Oral opioids are potent analgesics that are used to treat acute pain in the emergency department (ED). However, they are associated with adverse events such as sedation that may delay safe patient discharge. Objective: To compare the safety and efficacy of a new cyclooxygenase-2 inhibitor, valdecoxib, with those of an oxycodone-acetaminophen combination in patients with acute musculoskeletal pain. Methods: This was a double-blind, randomized controlled trial at an immediate care section of a suburban university-based ED with an annual census of 75,000. Adults with acute musculoskeletal pain without contraindications to the study medications were included. After recording their initial pain scores, patients were randomized to either oral valdecoxib 40 mg or oxycodone 10 mg with acetaminophen 650 mg. Pain scores were recorded at 30 and 60 minutes, and patients who requested additional pain relief were given an oral analgesic at the physician's discretion. Twenty-four-hour telephone follow-up was performed. The pain severity was recorded at 0, 30, and 60 minutes using a validated 100-mm visual analog scale marked "most" at the high end. The need for rescue medications and the occurrence of adverse events were determined. Study outcomes were compared with Student's t-test, repeated-measures analysis of variance (ANOVA), and chi(2) tests as appropriate. Results: Fifty-one patients were randomized to valdecoxib (26) or oxycodone (25). Mean (+/-SD) age was 36 (+/-14.7) years; 49% were women. Pain locations included extremities (49%), neck (29%), and back (22%). Baseline patient characteristics and pain severities were similar. There was no between-group difference in pain scores at 30 and 60 minutes. The changes in pain scores over time were also similar in the two study groups (repeated-measures ANOVA, p = 0.32). Patients treated with valdecoxib were less likely to experience sedation/dizziness (15% vs. 44%, p = 0.03) and to require rescue medications within the next 24 hours (44% vs. 74%, p = 0.04). Conclusions: Valdecoxib is as effective as an oxycodone-acetaminophen combination in treating ED patients with acute musculoskeletal pain at 30 minutes and less likely to cause sedation or the need for rescue analgesia over the next day.