In the treatment of post-operative pain in abdominal hysterectomy1,2*
Patients treated with Caldolor experienced...
Significant reduction in narcotic use1,2
- 19% reduction in median narcotic use
- 16% reduction in mean narcotic use (p<0.001)
And significant reduction in pain scores
† Area under the curve of patient-reported VAS scores.
p values based on LS means.
‡ Doses administered at 0, 6, 12, 18 hours
First dose administered intra-operatively (0 hour)
Caldolor dosing was initiated intra-operatively and continued in the post-operative period.
Kroll et al. Pain Practice, 2011.
*Results of a multi-center, double-blind, placebo-controlled trial of patients undergoing elective abdominal hysterectomy (N=319). Patients received 800 mg Caldolor or placebo intra-operatively and every 6 hours after surgery for 8 doses and then every 6 hours as needed for up to 5 days. All patients received morphine by PCA pump or patient request. Pain was assessed in the immediate post-operative period.
The most common adverse events reported were nausea, flatulence and pruritis.
Efficacy: Orthopedic Pain · Efficacy: Dose Ranging Pain
Important Safety Information
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.
Warning: Risk of Serious Cardiovascular and Gastrointestinal Events
Cardiovascular Risk
- Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use.
- CALDOLOR is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
- NSAIDs increase the risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Events can occur at any time without warning symptoms. Elderly patients are at greater risk.
Indications for CALDOLOR
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.
Please see full Prescribing Information, including Boxed Warning.
References:
Caldolor [prescribing information]. Nashville, TN: Cumberland Pharmaceuticals Inc; 2009.
Kroll PB, Meadows L, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (IV-ibuprofen) in the management of postoperative pain following abdominal hysterectomy. Pain Pract. 2011 Jan;11(1):23-32.