Morphine Plus Placebo vs Morphine Plus Acetaminophen for Acute Pain in the Emergency Department: A Randomized Clinical Trial
Authors' conclusion
In this randomized clinical trial of adults seen in the ED with acute pain, morphine plus placebo did not meet the criterion for noninferiority compared with morphine plus acetaminophen for pain relief during the initial management.
Study context
- Population
- Adults (≥18 years) in 11 French emergency departments (EDs) with severe acute traumatic or nontraumatic pain (NRS ≥5)424 modified intention-to-treat (mITT), 393 per-protocol (PP)
- Participants
- 430 adults
- Comparison
- Morphine plus placebo vs Morphine plus acetaminophen
- Morphine plus placebon = 213
- Morphine plus acetaminophenn = 211reference
- Primary endpoint
- Mean change in NRS pain score from baseline (non-inferiority margin 1 point)
- Follow-up
- 30 minutes
Methodological detailsmulticentre, double-blind, placebo-controlled, non-inferiority
- Multicentre
- Double-blind
- Placebo-controlled
- Non-inferiority
Primary result
As reported in the abstract
Mean change in NRS pain score from baseline to 30 min, by stratum
- In both strata pain reduction favoured the acetaminophen group; noninferiority not met
- Noninferiority margin 1 point; not met
- Prespecified strata: traumatic and nontraumatic pain
- Modified intention-to-treat (mITT) and per-protocol (PP) analyses
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Morphine Plus Placebo vs Morphine Plus Acetaminophen for Acute Pain in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. Published 2 February 2026. doi:10. 1001/ jamanetworkopen. 2025. 60250
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