Efficacy of an Ibuprofen/Codeine Combination for Pain Management in Children Presenting to the Emergency Department with a Limb Injury: A Pilot Study

Abstract Background Fractures and severe sprains generate moderate to severe pain (>3/10). Despite this fact, pain management in children presenting to the Emergency Department (ED) with a musculoskeletal trauma is still suboptimal. Few studies have focused on the efficacy of a combination of an opioid with an anti-inflammatory drug to relieve this type of pain. Study Objective To compare the efficacy of a combination of codeine with ibuprofen to ibuprofen alone on the intensity of pain experienced by children presenting to the ED with a musculoskeletal trauma to a limb. Methods This randomized, double-blind, placebo-controlled trial included patients aged 6 to 18 years. After triage, subjects were randomized to either ibuprofen (10 mg/kg, max 600 mg) and codeine (1 mg/kg, max 60 mg) orally, or ibuprofen (10 mg/kg, max 600 mg) and a placebo orally. Pain was assessed with the visual analog scale (0 to 10) at triage, and at 60, 90, and 120 min after medication administration. Differences on mean pain scores were compared between groups over time. Results We recruited 81 patients, 40 in the experimental group and 41 in the control group. No significant differences were observed in mean pain scores between groups at any time point. Mean pain scores were moderate at 90 min in both experimental and control groups (4.0 ± 2.4 vs. 4.1 ± 2.0, respectively). Side effects were minimal. Conclusion The addition of codeine to ibuprofen did not significantly improve pain management in children with musculoskeletal trauma to a limb. Pain control provided by the medications remained suboptimal for most patients.