Publication date: Jan 09, 2020
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.
Randomized controlled trial, double-blind, parallel, placebo-controlled.
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.
Administration of study medications.
Pain intensity measured by Numerical Rating Scale, opioid consumption adjusted to morphine equivalent dose and time to first narcotic administration.
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).
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.
Therapeutic Level I.
Weisz, R.D., Fokin, A.A., , Lerner, Flynt, A., , Macias-Perez, Pavliv, L., Crawford, M., and , Puente. Intravenous Ibuprofen Reduces Opioid Consumption During the Initial 48 Hours Post Injury in Orthopedic Trauma Patients. 04503. 2020 J Orthop Trauma.
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