A prospective, multicenter, randomized, double-blind trial of IV ibuprofen for treatment of fever and pain in burn patients.

This prospective study evaluated the efficacy and safety of IV ibuprofen for the reduction of fever and treatment of pain in patients with thermal burn injury. A total of 61 patients with second- and/or third-degree thermal burns covering >10% TBSA were randomly assigned in a 2:1 ratio to receive either 800 mg IV ibuprofen or placebo every 6 hours for 120 hours (5 days). Antipyretic medications were restricted during the first 24 hours of the study, but analgesics were allowed throughout. The primary efficacy endpoint was area under the curve for temperature (AUC-T°) within the first 24 hours of treatment. After 24 hours of dosing, there was a significant reduction in temperature in patients who received IV ibuprofen compared with those who received placebo (P = .008). The temperature remained reduced over the entire 120-hour dosing period in the patients who received IV ibuprofen, although the difference beyond 24 hours did not reach statistical significance. Because of enrollment of patients unable to perform self-assessments of pain, an inadequate number of patients were enrolled to detect differences in pain scores. There was no significant difference in the incidence of serious adverse events. Fever was reduced significantly by IV ibuprofen in burn patients over the initial 24-hour dosing period and remained reduced throughout the dosing period. Exposure to the maximum daily recommended dose of 3200 mg (800 mg every 6 hours) for a total of 120 hours (5 days) was well tolerated.