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

OBJECTIVES

To evaluate the efficacy of intravenous (IV) ibuprofen (Caldolor) 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 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 group that 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 (PI).

INTERVENTION: Administration of study medications.

OUTCOME MEASUREMENTS: PI measured by Numerical Rating Scale, opioid consumption adjusted to morphine equivalent dose, and time to first narcotic administration.

RESULTS

The 2 groups had comparable baseline characteristics: age, sex distribution, mechanism of injury, type of injury, injury severity score, and PI. IV ibuprofen statistically significantly reduced opioid consumption compared with placebo during the initial 48-hour period (P = 0.017). PI calculated as PI differences was statistically different only at 8-hour interval after Caldolor administration. Time to first narcotic medication was significantly longer in the Caldolor group (hazard ratio: 1.640; 95% confidence interval, 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 a recommended candidate for managing acute pain in the diverse orthopaedic trauma population.

LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.