ORAL MORPHINE VERSUS IBUPROFEN FOR AT-HOME POST-OPERATIVE ORTHOPAEDIC PAIN IN CHILDREN: A RANDOMIZED CONTROLLED TRIAL

Abstract

BACKGROUND: Most paediatric surgical procedures are currently performed on an outpatient basis and pain is the most common complaint of children. Oral morphine is being increasingly prescribed. However, evidence supporting its use for at home therapy post-operatively is non-existent. Given the growing fears surrounding opioids, an evaluation of oral morphine’s effectiveness was urgently needed in this clinical context. OBJECTIVES: We sought to evaluate whether oral morphine was superior to ibuprofen for children’s pain at home, following ambulatory orthopaedic surgery. DESIGN/METHODS: We conducted a parallel-group, randomized, blinded superiority trial comparing oral morphine (0.5 mg/kg, maximum 200 mg) to ibuprofen (10 mg/kg, maximum 600 mg) for at home therapy in children 5-17 years who underwent outpatient orthopaedic surgery. Participants were asked to take the intervention at home every 6 hours as needed for pain for 48 hours. The primary outcome was the pre-post difference in pain scores using the Faces Pain Scale – Revised (FPS-R) for the first medication dose. Secondary outcomes included the pre-post difference in pain scores using the FPS-R for the second to eighth doses, breakthrough acetaminophen doses for pain, unscheduled visits to a health care provider within 96 hours, and the type and frequency of adverse effects. RESULTS: We analyzed the results of 65 participants in the morphine group and 67 in the ibuprofen group. At each dose, both morphine and ibuprofen decreased pain scores with no difference in efficacy. Respectively, the mean (SD) pre-post difference was 1.1 (1), 1.8 (1.1), delta (∆) 0.3, 95% CI: -0.1, 0.7) (first); 1 (1.1), 1 (1), ∆: 0, 95% CI: -0.4, 0.4 (second); 1 (1.1), 0.9 (1.1), ∆: 0.1, 95% CI: -0.3, 0.5 (third); 0.9 (0.9), 0.9 (1), ∆: 0, 95% CI: -0.4, 0.4 (fourth); 0.8 (0.9), 0.9 (1.1), ∆: -0.2, 95% CI: -0.6, 0.2 (fifth); 0.8 (1), 0.7 (1), ∆: 0.1, 95% CI: -0.4, 0.5 (sixth); 0.6 (0.9), 0.6 (0.8), ∆: 0.1, 95% CI: -0.3, 0.4 (seventh); 0.4 (0.7), 0.5 (0.7), ∆: -0.1, 95% CI: -0.5, 0.2 (eighth). Significantly more participants in the morphine group (45/65, 69% versus 26/67, 39%) experienced adverse effects, most commonly drowsiness. There were no differences in health care visits. CONCLUSION: Both oral morphine and ibuprofen decreased pain at home with no difference in analgesic efficacy. Oral morphine was associated with significantly more adverse effects, suggesting ibuprofen is an effective and safer option for at home management of mild to moderate pain following ambulatory orthopaedic surgery.