Ibuprofen alone matches combination therapy for pediatric limb injury pain

In a Contemporary Pediatrics video interview, Samina Ali, MD, FRCPC, professor of Pediatrics & Emergency Medicine at the University of Alberta, discussed findings from a large, multicenter clinical trial evaluating pain management strategies for children with acute limb injuries.

The study included nearly 700 pediatric patients across 6 centers who presented with uncomplicated fractures or breaks that did not require surgical intervention. Researchers compared ibuprofen alone with combination regimens of ibuprofen plus acetaminophen and ibuprofen plus hydromorphone to determine relative effectiveness and safety.

The results showed that ibuprofen alone provided pain relief comparable to that of combination therapies. Adding acetaminophen or the opioid hydromorphone did not improve pain control.

Importantly, the use of hydromorphone was associated with a substantially higher burden of adverse effects, increasing side effects by approximately 4- to 5-fold. Based on these findings, Ali emphasized that ibuprofen alone should be the preferred medication for children with fractures or sprains who are being discharged from the emergency department.

Ali highlighted that the study’s key clinical takeaway is a shift away from routine use of combination analgesics, particularly opioids, for acute pediatric limb injuries. Instead, she advocated for pairing ibuprofen with nonpharmacologic strategies such as ice, immobilization, and distraction techniques. These approaches can enhance comfort without increasing medication-related risks.

Despite ibuprofen’s relative effectiveness, the study also revealed limitations. A significant proportion of children did not achieve what researchers defined as mild pain—rated as 3 out of 10 or lower—indicating that ibuprofen alone is often insufficient to fully control pain. This finding underscores the need for multimodal pain management that extends beyond oral medications.

Looking ahead, Ali identified 2 major directions for future research. One involves better quantifying the impact of nonpharmacologic interventions, such as ice or distraction, and understanding how they interact with medications such as ibuprofen. The second focuses on exploring topical pain relief options that could provide effective analgesia without requiring oral administration, which can be challenging for some children.

Ali concluded by stressing the broader importance of adequately treating pain in childhood. Poorly managed pain can have lasting consequences, including chronic pain syndromes and anxiety around medical care later in life. Effective, safe pain management for pediatric injuries, she noted, has implications not only for immediate comfort but also for long-term health and wellbeing.

No relevant disclosure.

Reference

Ali S, Klassen TP, Candelaria P, et al. Acetaminophen (paracetamol) or opioid analgesia added to ibuprofen for children’s musculoskeletal injury: two randomized clinical trials. JAMA. 2026. doi:10.1001/jama.2025.25033