Cumberland Pharmaceuticals Inc. announced in mid-May that results from a clinical study evaluating the safety and efficacy of Caldolor (ibuprofen) given intravenously to treat fever and pain in hospitalized burn patients was published in Volume 32, Number 1 of the Journal of Burn Care & Research.
The study demonstrated that Caldolor significantly reduces fever in these patients, including those with severe thermal burns. The newly published study also supports the safety of Caldolor as it involved the highest dose and duration of exposure to IV ibuprofen to date, demonstrating that the recommended maximum daily dose of 3200 mg/day over five days of treatment was well tolerated.
“Immediate and sustained regulation of body temperature and reduction of fever following a burn injury is critical to patient recovery as well as comfort,” said Dr. John T. Promes, principal investigator of the study, Director of Trauma Services and Associate Director for Surgical Education at Orlando Regional Medical Center.
“Because oral administration in hospitalized burn patients is often impossible due to sedation, intubation or other factors, fever reduction with an IV agent such as Caldolor is often necessary.” Further, as a non-steroidal anti-inflammatory drug (NSAID), Caldolor has the potential to stop the escalation of inflammation caused by burn injury and alleviate pain in addition to fever.
The trial was conducted at five U.S. and international sites, including hospital burn units and burn centers. The study evaluated 61 adult burn patients with second-degree or third-degree burns covering more than 10 percent total body surface area with an anticipated hospital stay of more than 72 hours and fever of 100.4 degrees or greater. Patients were administered 800 mg of Caldolor every six hours for five consecutive days. There was a significant reduction in temperature in the first 24 hours of treatment in patients receiving Caldolor compared with those receiving a placebo. Caldolor was well tolerated and there was no significant difference in adverse events between patients receiving placebo and those receiving Caldolor.
According to the American Burn Association, 1.1 million burn injuries require medical attention each year in the United States. Of these, approximately 50,000 burn injuries require hospitalization, 20,000 are major burn injuries affecting 25 percent of total body surface area and 4,500 people die. In addition, up to 10,000 people in the United States die every year from burn-related infections.
Caldolor is indicated for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, and for the reduction of fever in adults. It is the first FDA approved intravenous therapy for fever.