Acetaminophen or Nonsteroidal Anti-Inflammatory Drugs in Acute Musculoskeletal Trauma: A Multicenter, Double-Blind, Randomized, Clinical Trial.

STUDY OBJECTIVE

We determine whether pain treatment with acetaminophen was not inferior to nonsteroidal anti-inflammatory drugs or the combination of both in minor musculoskeletal trauma.

METHODS

The Paracetamol or NSAIDs in Acute Musculoskeletal Trauma Study was a double-blind, randomized, clinical trial conducted in 2 general practices and 2 emergency departments in the Netherlands. A total of 547 adults, aged 18 years and older, with acute blunt minor musculoskeletal extremity trauma were randomly assigned in a 1:1:1 ratio to acetaminophen 4,000 mg/day, diclofenac 150 mg/day, or acetaminophen 4,000 mg/day+diclofenac 150 mg/day during 3 consecutive days. Patients, health care staff, and outcome assessors were blinded for treatment allocation. Follow-up for each patient was 30 days. Primary outcome measures were between-group differences in mean numeric rating scale (NRS) pain scores in rest and with movement at 90 minutes after initial drug administration compared with baseline pain scores with a predefined noninferiority margin of 0.75 NRS points. Secondary outcomes included NRS pain scores during 3 consecutive days and need for additional analgesia.

RESULTS

One hundred eighty-two patients were treated with acetaminophen, 183 with diclofenac, and 182 with combination treatment. Intention-to-treat analysis revealed mean NRS reduction in rest -1.23 (95% confidence interval [CI] -1.50 to -0.95) and -1.72 (95% CI -2.01 to -1.44) with movement, both for acetaminophen at 90 minutes compared with baseline. Pairwise comparison in rest with diclofenac showed a difference of -0.027 (97.5% CI -0.45 to 0.39) and -0.052 (97.5% CI -0.46 to 0.36) for combination treatment. With movement, these numbers were -0.20 (97.5% CI -0.64 to 0.23) and -0.39 (97.5% CI -0.80 to 0.018), respectively. All differences were well below the predefined noninferiority margin.

CONCLUSION

Pain treatment with acetaminophen was not inferior to that with diclofenac or the combination of acetaminophen and diclofenac in acute minor musculoskeletal extremity trauma, both in rest and with movement.