Pain Relief After Operative Treatment of an Extremity Fracture: A Noninferiority Randomized Controlled Trial.

ABSTRACT

BACKGROUND: Opioid pain medication is frequently given to patients recovering from a surgical procedure for an extremity fracture in spite of evidence that acetaminophen may be adequate. The aim of this study was to determine whether prescription of step 1 pain medication (acetaminophen) is noninferior to step 2 pain medication (acetaminophen and tramadol) after operative treatment of an extremity fracture. METHODS: Fifty-two patients with a single extremity fracture were randomized from July 2012 to March 2015 in this 2-week follow-up, noninferiority trial in a level-I trauma center in the Netherlands. Patients were randomly assigned to receive step 1 (acetaminophen) or step 2 (acetaminophen and tramadol) medication in standard doses on an as-needed basis on discharge. Intention-to-treat and per-protocol analyses were conducted. The primary outcome was self-reported satisfaction with pain relief measured on an 11-point ordinal scale. The hypothesis being tested was formulated before the collection of data. The mean differences between the groups were reported for intention-to-treat and per-protocol analyses. RESULTS: A total of 52 patients, with equal baseline characteristics, were analyzed in this study; the step 1 group consisted of 27 subjects and the step 2 group consisted of 25 subjects. The mean satisfaction with pain management was 8.3 for step 1 and 8.5 for step 2 medications. This mean difference of 0.2 point (95% confidence interval [CI], -0.78 to 1.30 points) did not exceed the noninferiority margin of 2.0 points, indicating that step 1 was noninferior to step 2. A similar result was found in the per-protocol analysis (mean difference, 0.2 point [95% CI, -1.03 to 1.57 points]). CONCLUSIONS: This study offers evidence to suggest that prescription of acetaminophen is not inferior compared with acetaminophen and tramadol in patients who underwent operative treatment for an extremity fracture. Given that tramadol has more side effects and is potentially habit-forming, acetaminophen should be considered the mainstay for pain relief in patients recovering from extremity fracture surgical procedures. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.