Level 2: Mid-level evidence
A randomized trial evaluated the efficacy of three analgesia regimens in 336 children aged 6-17 years who presented to an emergency department (ED) with pain from a musculoskeletal injury to the extremities, neck, or back (Pediatrics. 2007;119:460-467). To be included in the trial, the injury had to occur within 48 hours of presentation. Children were randomized to a single oral dose of acetaminophen 15 mg/kg (maximum 650 mg) vs. ibuprofen 10 mg/kg (maximum 600 mg) vs. codeine 1 mg/kg (maximum 60 mg).
Children, parents, and research assistants were all blinded to treatment assignment. Pain was measured on a 100-mm visual analog scale. A score of 100 was labeled as “worst pain”; a change in score of 9-18 mm was considered clinically important. The only potentially significant baseline difference was the pain score: 16% of the acetaminophen group, 10% of the ibuprofen group, and 24% of the codeine group had scores <30 mm. Fifty-four percent of patients had a fracture and 46% had soft-tissue injury.
Follow-up measurements were obtained for 311 children (92.6%) at 30 minutes, 300 (89%) at 60 minutes, 263 (78%) at 90 minutes, and 237 (70.5%) at 120 minutes. In a per-protocol analysis, ibuprofen was associated with significantly reduced pain scores at 60, 90, and 120 minutes. Comparing acetaminophen vs. ibuprofen vs. codeine, the change in pain score was -12, -24, and -11 at 30 minutes (P <.001), -17, -29, and -13 at 90 minutes (P =.001), and -20, -31, and -17 at 120 minutes (P =.004). There was no significant difference at 30 minutes (-7, -12, and -10). A higher proportion of ibuprofen patients had pain score <30 at 60 minutes (36% vs. 52% vs. 40%, P <.001), but this was no longer significantly different at 120 minutes (27% vs. 51% vs. 39%). There was no difference in number of patients requiring additional analgesia (16% vs. 14% vs. 22%). Results were significant in the subgroup of children with fractures but not in the subgroup of children with soft-tissue injury.