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Original Investigation
November 7, 2017

Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency DepartmentA Randomized Clinical Trial

Author Affiliations
  • 1Department of Emergency Medicine, Albany Medical College, Albany, New York
  • 2Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York
JAMA. 2017;318(17):1661-1667. doi:10.1001/jama.2017.16190
Key Points

Question  Do any of 4 oral combination analgesics (3 with different opioids and 1 opioid-free) provide more effective reduction of moderate to severe acute extremity pain in the emergency department (ED)?

Findings  In this randomized clinical trial of 411 ED patients with acute extremity pain (mean score, 8.7 on the 11-point numerical rating scale), there was no significant difference in pain reduction at 2 hours. Mean pain scores decreased by 4.3 with ibuprofen and acetaminophen (paracetamol); 4.4 with oxycodone and acetaminophen; 3.5 with hydrocodone and acetaminophen; and 3.9 with codeine and acetaminophen.

Meaning  For adult ED patients with acute extremity pain, there were no clinically important differences in pain reduction at 2 hours with ibuprofen and acetaminophen or 3 different opioid and acetaminophen combination analgesics.

Abstract

Importance  The choice of analgesic to treat acute pain in the emergency department (ED) lacks a clear evidence base. The combination of ibuprofen and acetaminophen (paracetamol) may represent a viable nonopioid alternative.

Objectives  To compare the efficacy of 4 oral analgesics.

Design, Settings, and Participants  Randomized clinical trial conducted at 2 urban EDs in the Bronx, New York, that included 416 patients aged 21 to 64 years with moderate to severe acute extremity pain enrolled from July 2015 to August 2016.

Interventions  Participants (104 per each combination analgesic group) received 400 mg of ibuprofen and 1000 mg of acetaminophen; 5 mg of oxycodone and 325 mg of acetaminophen; 5 mg of hydrocodone and 300 mg of acetaminophen; or 30 mg of codeine and 300 mg of acetaminophen.

Main Outcomes and Measures  The primary outcome was the between-group difference in decline in pain 2 hours after ingestion. Pain intensity was assessed using an 11-point numerical rating scale (NRS), in which 0 indicates no pain and 10 indicates the worst possible pain. The predefined minimum clinically important difference was 1.3 on the NRS. Analysis of variance was used to test the overall between-group difference at P = .05 and 99.2% CIs adjusted for multiple pairwise comparisons.

Results  Of 416 patients randomized, 411 were analyzed (mean [SD] age, 37 [12] years; 199 [48%] women; 247 [60%] Latino). The baseline mean NRS pain score was 8.7 (SD, 1.3). At 2 hours, the mean NRS pain score decreased by 4.3 (95% CI, 3.6 to 4.9) in the ibuprofen and acetaminophen group; by 4.4 (95% CI, 3.7 to 5.0) in the oxycodone and acetaminophen group; by 3.5 (95% CI, 2.9 to 4.2) in the hydrocodone and acetaminophen group; and by 3.9 (95% CI, 3.2 to 4.5) in the codeine and acetaminophen group (P = .053). The largest difference in decline in the NRS pain score from baseline to 2 hours was between the oxycodone and acetaminophen group and the hydrocodone and acetaminophen group (0.9; 99.2% CI, −0.1 to 1.8), which was less than the minimum clinically important difference in NRS pain score of 1.3. Adverse events were not assessed.

Conclusions and Relevance  For patients presenting to the ED with acute extremity pain, there were no statistically significant or clinically important differences in pain reduction at 2 hours among single-dose treatment with ibuprofen and acetaminophen or with 3 different opioid and acetaminophen combination analgesics. Further research to assess adverse events and other dosing may be warranted.

Trial Registration  clinicaltrials.gov Identifier: NCT02455518

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