Paediatric anaesthesia & critical care
Acetaminophen (Paracetamol) or Opioid Analgesia Added to Ibuprofen for Children’s Musculoskeletal Injury: Two Randomized Clinical Trials
Authors' conclusion
For children with acute nonoperative musculoskeletal injury, pain scores at 60 minutes after drug administration did not improve with ibuprofen plus acetaminophen or ibuprofen plus hydromorphone compared with ibuprofen alone. Adverse events were 4-fold more frequent with hydromorphone.
Study context
- Population
- Children aged 6 to 17 years with nonoperative acute limb injury (<24 hours) and verbal numerical rating scale (vNRS) pain score ≥5/10, Canadian pediatric EDs653 included in efficacy analyses
- Participants
- 699 children
- Comparison
- Ibuprofen plus hydromorphone or ibuprofen plus acetaminophen vs ibuprofen alone (single oral dose)
- Ibuprofen plus hydromorphonen = 110
- Primary endpoint
- Self-reported vNRS pain score (0 [no pain] to 10 [worst pain]; minimal clinically important difference, 1.5)
- Follow-up
- 60 minutes post medication administration
Methodological detailstwo trials (opioid and nonopioid), pooled analyses, double-masked, placebo-controlled, multicentre (6 Canadian pediatric EDs), April 2019 to March 2023, Opioid trial: 249 children (110 ibuprofen plus hydromorphone, 70 ibuprofen plus acetaminophen, 69 ibuprofen alone); nonopioid trial: 450 children (225 ibuprofen plus acetaminophen, 225 ibuprofen alone)
- Two trials (opioid and nonopioid), pooled analyses
- Double-masked
- Placebo-controlled
- Multicentre (6 Canadian pediatric EDs)
- April 2019 to March 2023
- Opioid trial: 249 children (110 ibuprofen plus hydromorphone, 70 ibuprofen plus acetaminophen, 69 ibuprofen alone); nonopioid trial: 450 children (225 ibuprofen plus acetaminophen, 225 ibuprofen alone)
Primary result
As reported in the abstract
vNRS pain score (pooled analyses) · 60 minutes after drug administration
Ibuprofen plus hydromorphone
4.8
mean · SD 2.6
Ibuprofen plus acetaminophen
4.6
mean · SD 2.4
Ibuprofen alone
4.6
mean · SD 2.3
P = 0.78
Safety
Any adverse event related to study drug (primary safety end point)
Serious adverse events
- No serious adverse events occurred
Original publication
Acetaminophen (Paracetamol) or Opioid Analgesia Added to Ibuprofen for Children’s Musculoskeletal Injury: Two Randomized Clinical Trials. JAMA. Published 10 March 2026. doi:10.
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