A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients

Objective. To determine whether pre‐ and post‐operative administration of intravenous ibuprofen (IV‐ibuprofen) can significantly decrease pain and morphine use when compared with placebo in adult orthopedic surgical patients. Design. This was a multi‐center, randomized, double‐blind placebo‐controlled trial. Setting. This study was completed at eight hospitals; six in the United States and two in South Africa. Patients. A total of 185 adult patients undergoing elective orthopedic surgery. Interventions. Patients were randomized to receive either 800 mg IV‐ibuprofen or placebo every 6 hours, with the first dose administered pre‐operatively. Additionally, all patients had access to intravenous morphine for rescue. Outcome Measures. Efficacy of IV‐ibuprofen was demonstrated by measuring the patient's self assessment of pain using a visual analog scale (VAS; assessed with movement and at rest) and a verbal response scale (VRS). Morphine consumption during the post‐operative period was also assessed. Results. In the immediate post‐operative period, there was a 25.8% reduction in mean area under the curve‐VAS assessed with movement (AUC‐VASM) in patients receiving IV‐ibuprofen (P