New data supports the safety and efficacy of Cumberland Pharmaceuticals Incs.'s Caldolor (ibuprofen) Injection.
New data supports the safety and efficacy of Cumberland Pharmaceuticals Inc.’s Caldolor (ibuprofen) Injection.
The product, also known as IV ibuprofen, was tested on pre- and post-operative orthopedic surgery patients in a study that appears in the journal of Pain Medicine. The results demonstrated that IV ibuprofen significantly decreased pain and morphine use compared to placebo.
“These findings are significant in that they not only confirm that Caldolor is effective in reducing both post-operative pain and morphine use, but also demonstrate that it can be safely administered prior to the induction of anesthesia," said Neil Singla, M.D., chief executive officer of Lotus Clinical Research, Inc. and principal investigator of the study, in a press release. “This gives physicians additional options for controlling the onset of post-operative pain, which can help improve patient comfort and thereby facilitate recovery.”
The product decreased morphine use by more than 30% and improved pain control. The trial evaluated 185 adult patients undergoing orthopedic surgery at eight hospitals. The patients were randomized and received either 800 mg IV ibuprofen or placebo every six hours. Pain was measured through patient self-assessment using visual analog scale and verbal response scale in the immediate post-operative period through the 28th hour of the study. The patients also had access to intravenous morphine.
Those that received IV ibuprofen reported a 26% reduction in pain with movement. During rest, pain was reduced by 32% and morphine was used nearly 31% less than placebo.
However, more patients receiving IV ibuprofen experienced vomiting and more patients receiving placebo experienced dyspepsia.