A multi-center, randomized, double-blind, placebo-controlled trial evaluating the safety and analgesic efficacy of IV Ibuprofen vs. placebo in 185 patients undergoing elective orthopedic surgery.
In a study by Singla et al. 185 patients were enrolled in a multi-center, double-blind, placebo-controlled trial. Each patient had elective orthopedic surgery consisting of knee or hip replacement, reconstruction, or arthroplasty. CALDOLOR or a placebo was administered at induction of anesthesia and every 6 hours for 5 doses, and then as needed every 6 hours during the post-operative hospital stay. All patients had open access to morphine. Pain assessments were initiated when patients were alert in the recovery room. The primary objective of the study was to determine the efficacy of CALDOLOR (IV Ibuprofen) compared with placebo for the treatment of post-operative surgical pain demonstrated by patient self-assessment of pain with movement, using a Visual Analog Scale (VAS). The secondary endpoints evaluated early post-operative pain relief and morphine usage. While patients were excluded if they were receiving full dose anticoagulation therapy, approximately 19% of the patients enrolled in the study were receiving partial anticoagulation therapy in the 12 hours preceding surgery and 60% received anticoagulation therapy following surgery.
VAS assessed at rest and with movement with 800 mg IV Ibuprofen over the immediate 28 hours following surgery:*
VAS = visual analog pain scale
* Statistical significance was demonstrated at each assessment period.
CALDOLOR must be diluted prior to use. Infusion of the drug product without dilution can cause hemolysis. CALDOLOR should not be given as an IV bolus or IM injection.1