Tramadol/Acetaminophen or Hydrocodone/Acetaminophen for the Treatment of Ankle Sprain: A Randomized, Placebo-Controlled Trial.
Author(s): Hewitt DJ, Todd KH, Xiang J, Jordan DM, Rosenthal NR, for the CAPSS-216 Study Investigators
Affiliation(s): PriCara, Unit of Ortho-McNeil, Inc., Raritan, NJ (Hewitt, Jordan, Rosenthal).
Publication date & source: 2006-11-17, Ann Emerg Med., [Epub ahead of print]
STUDY OBJECTIVE: This randomized, multicenter study compares the analgesic efficacy and safety of tramadol/acetaminophen versus hydrocodone/acetaminophen versus placebo for the treatment of acute musculoskeletal pain caused by ankle sprain. METHODS: Adults were enrolled with ankle sprain with a diagnosis of partial ligament tear, pain visual analog scale score of 50 to 100 mm (0="no pain," 100="extreme pain"), and pain numeric rating scale score of 2 to 3 (0="none," 3="severe"). Patients reported pain intensity on these scales and pain relief (-1="pain worse," 4="complete relief") hourly for 4 hours after the first dose of tramadol/acetaminophen 75 mg/650 mg, hydrocodone/acetaminophen 7.5 mg/650 mg, or placebo, and daily for 5 days, with as-needed dosing. RESULTS: Tramadol/acetaminophen (n=192) and hydrocodone/acetaminophen (n=204) provided greater total pain relief than placebo (n=207; P<.001) during the first 4 hours (mean scores [95% confidence interval (CI)] 6.6 [95% CI 6.1 to 7.1], 6.8 [95% CI 6.3 to 7.3], and 5.4 [95% CI 4.9 to 5.9], respectively; possible range -4 to 16), decreased pain intensity during the first 4 hours, and increased average pain relief on days 1 to 5. No efficacy measure was significantly different between the tramadol/acetaminophen and hydrocodone/acetaminophen groups. Common adverse events included somnolence, nausea, dizziness, and vomiting. CONCLUSION: One or 2 capsules of 37.5 mg tramadol/325 mg acetaminophen and 1 capsule of 7.5 mg hydrocodone/650 mg acetaminophen were well tolerated, had comparable clinical utility, and were more effective than placebo in the management of acute musculoskeletal pain caused by ankle sprain.