Intravenous Ibuprofen Reduces Opioid Consumption During the Initial 48 Hours Post Injury in Orthopedic Trauma Patients

OBJECTIVES: To evaluate the efficacy of IV ibuprofen (Caldolor(R)) administration in the management of acute pain in orthopedic trauma patients and to minimize opioid use. DESIGN: Randomized controlled trial, double-blind, parallel, placebo-controlled. SETTING: Level 1 Trauma Center PATIENTS:: A total of 99 consecutive orthopedic trauma patients with fractures of the ribs, face, extremities and/or pelvis were randomized to receive either 800 mg intravenous (IV) ibuprofen (53 patients) or placebo (44 patients) administered every 6 hours for a total of 8 doses within 48 hours of admission and the same PRN medications along with 20 mg IV/PO Pepcid twice a day. To establish pain reduction efficacy, the analysis was consequently performed in the modified intent to treat (mITT) group which included 74 randomized subjects with a baseline pain score greater than 2. The primary outcomes were reduction in opioid consumption and decrease in pain intensity. INTERVENTION: Administration of study medications. OUTCOME MEASUREMENTS: Pain intensity measured by Numerical Rating Scale, opioid consumption adjusted to morphine equivalent dose and time to first narcotic administration. RESULTS: The two groups had comparable baseline characteristics: age, gender distribution, mechanism of injury, type of injury, injury severity score and pain intensity. IV ibuprofen statistically significantly reduced opioid consumption compared to placebo during the initial 48-hour time period (p = 0.017). Pain intensity calculated as pain intensity differences was statistically different only at 8 hour interval after Caldolor(R) administration. Time to first narcotic medication was significantly longer in the Caldolor(R) group (HR: 1.640; 95% CI: 1.009, 2.665; p=0.046). CONCLUSIONS: IV ibuprofen provided adequate analgesia, prolonged time to first narcotic administration and was opioid-sparing for the treatment of pain in orthopedic trauma patients, which makes Caldolor(R) a recommended candidate for managing acute pain in the diverse orthopaedic trauma population. LEVEL OF EVIDENCE: Therapeutic Level I.