A multi-center, randomized, double-blind, placebo-controlled trial evaluating the safety and analgesic efficacy of IV Ibuprofen vs. placebo in 319 patients undergoing elective abdominal hysterectomy.
A total of 319 female patients were randomized into two treatment groups that both had open access to morphine, with 153 patients in the placebo group and 166 patients in the IV Ibuprofen group. The first dose of 800 mg of IV Ibuprofen was administered at surgical closure, and every 6 hours for up to 5 days, in addition to open access morphine. The primary efficacy endpoint was a reduction in the requirement for morphine during the first 24 hours following surgery as measured by total morphine usage compared with placebo. Additional endpoints included reduction in pain intensity as measured by VAS over the immediate 24 hours following surgery, and incidence of opioid related side effects. This study demonstrated that IV Ibuprofen is an effective analgesic medication that is safe and well tolerated when administered as an 800 mg dose every 6 hours in patients undergoing total abdominal hysterectomy surgery.
VAS assessed at rest and with movement with 800 mg IV Ibuprofen 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