Black box warning: is ketorolac safe for use after cardiac surgery?

Abstract

OBJECTIVE:

In 2005, after the identification of cardiovascular safety concerns with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), the FDA issued a black box warning recommending against the use of NSAIDs following cardiac surgery. The goal of this study was to assess the postoperative safety of ketorolac, an intravenously administered NSAID, after cardiac surgery.

DESIGN:

Retrospective observational study.

SETTING:

Single center, regional hospital.

PARTICIPANTS:

A total of 1,309 cardiac surgical patients (78.1% coronary bypass, 28.0% valve) treated between 2006 and 2012.

INTERVENTIONS:

A total of 488 of these patients received ketorolac for postoperative analgesia within 72 hours of surgery.

MEASUREMENT AND MAIN RESULTS:

Ketorolac-treated patients were younger, had better preoperative renal function, and underwent less complex operations compared with non-ketorolac patients. Ketorolac was administered, on average, 8.7 hours after surgery (mean doses: 3.1). Postoperative outcomes for ketorolac-treated patients were similar to those expected using Society of Thoracic Surgery database risk-adjusted outcomes. In unadjusted analysis, patients who received ketorolac had similar or better postoperative outcomes compared with patients who did not receive ketorolac, including gastrointestinal bleeding (1.2% v 1.3%; p = 1.0), renal failure requiring dialysis (0.4% v 3.0%; p = 0.001), perioperative myocardial infarction (1.0% v 0.6%; p = 0.51), stroke or transient ischemic attack (1.0% v 1.7%; p = 0.47), and death (0.4% v 5.8%; p<0.0001). With adjustment in a multivariate model, treatment with ketorolac was not a predictor for adverse outcome in this cohort (odds ratio: 0.72; p = 0.23).

CONCLUSIONS:

Ketorolac appears to be well-tolerated for use when administered selectively after cardiac surgery. Although a black box warning exists, the data highlights the need for further research regarding its perioperative administration.

• Authors: Lisa Oliveri, Katie Jerzewski, Alexander Kulik
• Journal: Journal of cardiothoracic and vascular anesthesia (J Cardiothorac Vasc Anesth) Vol. 28 Issue 2 Pg. 274-9 (Apr 2014) ISSN: 1532-8422 [Electronic] United States
• PMID: 24231193 (Publication Type: Journal Article, Observational Study)
• Copyright: Copyright © 2014 Elsevier Inc. All rights reserved.

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Creatinine
• Ketorolac

Topics

• Aged
• Aged, 80 and over
• Anti-Inflammatory Agents, Non-Steroidal (adverse effects, therapeutic use)
• Cardiac Surgical Procedures (methods, mortality)
• Cohort Studies
• Coronary Artery Bypass
• Creatinine (blood)
• Databases, Factual
• Dialysis
• Female
• Humans
• Ketorolac (adverse effects, therapeutic use)
• Kidney Function Tests
• Logistic Models
• Male
• Middle Aged
• Pain, Postoperative (drug therapy)
• Postoperative Hemorrhage (epidemiology, therapy)
• Reoperation
• Retrospective Studies
• Risk Assessment
• Treatment Outcome