A trial of Cumberland Pharmaceuticals Inc.'s pain management drug Caldolor showed that the drug improved postoperative pain control and reduced opioid use in patients undergoing transsphenoidal surgery.
Caldolor is indicated in adults and pediatric patients six months and older for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever.
The trial compared outcomes in two groups of patients treated with multimodal pain management protocols following transsphenoidal surgery for pituitary lesions. The primary endpoint was patient pain scores measured on a zero to 10 visual analog scale and the secondary endpoint was the estimated oral morphine equivalent used for breakthrough pain in the first 48 hours after surgery.
Patients in the Caldolor group demonstrated a significant reduction of 43% in mean scores on the visual analog scale compared with the placebo group. Opioid use was also significantly different with a 58% reduction in Caldolor patients versus patients on placebo.
The study was terminated early because the planned interim analysis demonstrated that the primary and secondary endpoints had been reached.