Tramadol/Acetaminophen or Hydrocodone/Acetaminophen for the Treatment of Ankle Sprain: A Randomized, Placebo-Controlled Trial

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