Monotherapy With Ibuprofen Is Optimal for Children With Acute Nonoperative Musculoskeletal Injuries

Is the combination of acetaminophen or opioid analgesia plus ibuprofen equally safe or safer and more effective than ibuprofen alone for pain relief in children with acute nonoperative musculoskeletal injury?

For children with acute nonoperative musculoskeletal pain who present to the emergency department, the addition of acetaminophen or hydromorphone to ibuprofen did not improve pain relief at 1 hour compared with ibuprofen alone. Adverse events occurred four times more often with the addition of hydromorphone. (Level of Evidence = 1b)

Ibuprofen, naproxen, and acetaminophen alone have been shown to be equally effective for reducing pain intensity compared with adding opioid analgesia in adults with acute pain. The investigators identified 699 children aged 6 to 17 years from two separate clinical trials conducted in Canada who presented to the emergency department with acute limb injury without obvious deformity or neurovascular compromise that necessitated urgent surgical intervention. Study participants randomly received assignment to one of three groups: (1) oral ibuprofen plus acetaminophen placebo plus oral hydromorphone, (2) oral ibuprofen plus oral acetaminophen plus hydromorphone placebo, or (3) oral ibuprofen plus acetaminophen placebo plus hydromorphone placebo. The dose of ibuprofen used was 10 mg/kg (maximum: 600 mg), acetaminophen was 15 mg/kg (maximum: 1,000 mg), and oral hydromorphone was 0.05 mg/kg (maximum: 5 mg). The primary outcome was self-reported pain on a validated pain scoring tool ranging from 0 (no pain) to 10 (worst pain) at 1 hour after medication administration. Patients, family members, and clinical staff were masked to treatment group assignments. Complete data were available for 93.4% of participants.

Using intention-to-treat analyses, no significant group differences occurred in self-reported pain (mean = 4.7; standard deviation = 2.4). However, adverse events (eg, somnolence, nausea/vomiting, dizziness) occurred significantly more often in the ibuprofen plus hydromorphone group (28.2%) than in the ibuprofen plus acetaminophen (6.1%) and ibuprofen alone (5.8%) groups. No group differences occurred in the need for rescue analgesia (none in any of the groups) or length of stay in the emergency department.

Study Design: Randomized controlled trial (double-blinded)

Funding Source: Government and foundation

Allocation: Concealed

Setting: Emergency department