The 400 mg dose was associated with 3% reduction in morphine use, 7% reductions in pain at rest, and 9% reductions with movement.
Caldolor dosing was initiated intra-operatively and continued in the post-operative period.
Similar treatment emergent adverse events were reported in both study groups. The most common adverse event reported in this clinical trial were nausea, vomiting, and constipation.
Southworth et al. Clinical Therapeutics, 2009.
*A multicenter, double-blind, randomized, placebo-controlled, dose-ranging trial of 406 adult patients undergoing elective, single-site abdominal or orthopedic surgery who received post-operative morphine (by patient-controlled analgesia or patient request) who were administered IV ibuprofen 400 mg (n=138), IV ibuprofen 800 mg (n=134), or placebo (n=134). IV ibuprofen and placebo were initiated intraoperatively and administered every 6 hours for 8 doses and then as needed every 6 hours for up to 5 days following surgery.
Efficacy: Orthopedic Pain · Efficacy: Abdominal Hysterectomy Pain
CALDOLOR should be used with caution in patients with congestive heart failure, kidney impairment, at risk of blood clots, and in those who have a history of ulcers or gastrointestinal bleeding. When used in such patients, attention to using the lowest effective dose for the shortest time period is important to reduce the risk of serious adverse events. Ibuprofen has been associated with high blood pressure, serious skin reactions, and serious allergic reactions.
The most common adverse events reported in the controlled clinical trials were nausea, flatulence, vomiting, and headache.
CALDOLOR is indicated in adults for the management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, and reduction of fever.
Southworth S, Peters J, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain. Clin Ther. 2009;31(9):1922-1935.