TRAMADOL VERSUS HYDROCODONE-ACETAMINOPHEN IN ACUTE MUSCULOSKELETAL PAIN - A RANDOMIZED, DOUBLE-BLIND CLINICAL-TRIAL

Study objective: To evaluate the efficacy of an oral tramadol preparat ion versus that of an oral hydrocodone-acetaminophen preparation in ac ute musculoskeletal pain. Methods: A randomized, prospective, double-b lind clinical trial was conducted in an urban teaching emergency depar tment with an annual census of 41,000. Participants comprised a conven ience sample of 68 adult ED patients with acute musculoskeletal pain c aused by minor trauma. Thirty-three patients received tramadol (100 mg ), and 35 patients received hydrocodone-acetaminophen (5 mg hydrocodon e with 500 mg acetaminophen). The drugs were prepared in identical-app earing capsules. Pain was evaluated by a 100-mm visual analog scale (V AS) at baseline and at 30, 60, 90, 120, and 180 minutes after dosing. VAS scores were analyzed by 2-way repeated-measures ANOVA, and nominal data were analyzed by Fisher's exact test. Results: Mean pain scores did not differ at baseline (tramadol, 68.3 +/- 21.8; hydrocodone-aceta minophen, 69.1 +/- 17.8; P = NS) but were significantly lower in the h ydrocodone-acetaminophen group beginning at 30 minutes through 180 min utes. There were 6 dropouts as a result of reported inadequate analges ia, 3 in each group (P = NS). The discharge diagnoses and prevalence o f side effects did not differ significantly between groups. Conclusion : Tramadol provides inferior analgesia to hydrocodone-acetaminophen in ED patients with acute musculoskeletal pain.