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Ibuprofen alone provides effective pain relief for children with acute musculoskeletal injuries, with no added benefit from acetaminophen or opioid combinations.
Ibuprofen remains the first-line treatment for musculoskeletal pain in children, yet nearly two-thirds experience insufficient pain control with ibuprofen alone. To address whether adding another analgesic could improve outcomes, Samina Ali and other researchers executed two randomized, double-masked, placebo-controlled trials in 6 university-affiliated tertiary pediatric emergency departments in Canada.
The studies enrolled children aged 6 to 17 years who presented within 24 hours of a nonoperative acute limb injury and reported moderate to severe pain, defined as a verbal numerical rating scale (vNRS) score of 5 or higher out of 10. Out of 8,098 screened pediatrics, 699 were randomized and 653 were incorporated in the efficacy assessments. In the opioid trial, 249 children were randomized to receive a single oral dose of:
In the nonopioid trial, 450 children received either:
Ibuprofen was given at 10 mg/kg (maximum 600 mg) in all groups. Acetaminophen was dosed at 15 mg/kg (maximum 1,000 mg), and hydromorphone at 0.05 mg/kg (maximum 5 mg). The primary outcome was pain intensity at 60 minutes after medication administration, measured by vNRS (0 = no pain, 10 = worst pain), with a minimal clinically important difference set at 1.5 points. Safety was assessed by the percentage of children witnessing any treatment-related adverse event.
The mean age across both trials was 11.5 years (standard deviation [SD] 3.5), 47.4% were female, and the mean baseline pain score was 6.4 (SD 1.8). At 60 minutes post-treatment, pooled mean (SD) pain scores were:
There were no statistically or clinically meaningful differences between groups. Safety findings revealed a clear contrast. Any adverse event occurred in 28.2% of children receiving ibuprofen + hydromorphone, compared with 6.1% in the ibuprofen + acetaminophen group and 5.8% in the ibuprofen-only group. No serious adverse events were reported.
Hence, in children with acute, nonoperative musculoskeletal injuries, adding acetaminophen or the opioid hydromorphone to ibuprofen does not improve short-term pain relief. Opioid use, however, substantially escalates the risk of adverse events—by nearly fourfold—reinforcing ibuprofen monotherapy as the preferred initial treatment in pediatric emergency care.
JAMA
Acetaminophen (Paracetamol) or Opioid Analgesia Added to Ibuprofen for Children's Musculoskeletal Injury: Two Randomized Clinical Trials
Samina Ali et al.
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