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

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.