A multi-center, randomized, double-blind, placebo-controlled dose–ranging trial evaluating the safety and analgesic efficacy of IV ibuprofen vs. placebo in 406 patients undergoing orthopedic or abdominal surgery.
In this dose ranging study using CALDOLOR (IV Ibuprofen) in patients undergoing elective, single site orthopedic or abdominal surgery, IV Ibuprofen 400 mg and 800 mg was administered intra-operatively at surgical closure and every 6 hours post-operatively. The treatment and placebo groups also had open access to morphine. Results showed a significant morphine sparing effect and a significant reduction in pain at rest and with movement with the 800 mg dose of IV Ibuprofen as measured by Visual Analog Scale (VAS) compared to placebo patients.
VAS assessed at rest and with movement with 400 mg and 800 mg over the immediate 24 hours following surgery:
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