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Pre and Post-Operative Use of Caldolor® (Ibuprofen) Injection Significantly Reduces Pain and Opioid Use in Newly Published Study
Date:8/30/2010

patients had access to intravenous morphine. The study met its primary endpoint as patients who received IV ibuprofen reported a 26% reduction in pain with movement (p<0.001). The study also met its secondary endpoints as pain assessed during rest was reduced by 32% in patients receiving IV ibuprofen (p<0.001), and these patients used nearly 31% less morphine than those who received placebo (p<0.001). There was no significant difference between placebo and IV ibuprofen in the number of patients with bleeding adverse events, the incidence of blood transfusions or other serious adverse events. More patients receiving IV ibuprofen experienced vomiting and more patients receiving placebo experienced dyspepsia.

The study demonstrated that both pre-operative and post-operative administration of Caldolor diminished post-surgical pain. In previous clinical studies of IV ibuprofen, the initial dose was administered intra-operatively. However, patients in this study received the first dose of study drug at the induction of anesthesia through a peripheral or central venous catheter. Pain assessments were performed at regular intervals following surgery, with the average first assessment occurring 2.8 hours post-operatively. The difference in pain scores between patients receiving Caldolor plus morphine compared to morphine alone was significant at this first measurement and remained significant at every point of measurement throughout the study period.  

"This clinical study is so important because it provides strong safety and efficacy data supporting use of Caldolor in surgical patients not only during recovery, but also when administered prior to surgery," said A.J. Kazimi, Chief Executive Officer at Cumberland Pharmaceuticals. "Caldolor is the only IV-NSAID available in the United States that does not carry a contraindication for pre-operative use, and we believe this data will provide physicians with a new level of comfort in using IV ibuprofe
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SOURCE Cumberland Pharmaceuticals Inc.
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