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Parenteral Ketorolac: The Risk for Acute Renal Failure

Harold I. Feldman, MD, MS; Judith L. Kinman, MA; Jesse A. Berlin, ScD; Sean Hennessy, PharmD, MS; Stephen E. Kimmel, MD, MS; John Farrar, MD; Jeffrey L. Carson, MD; and Brian L. Strom, MD, MPH
[+] Article and Author Information

From University of Pennsylvania Medical Center, Philadelphia, Pennsylvania; and University of Medicine and Dentistry of New Jersey, New Brunswick, New Jersey. Acknowledgments: The authors thank the departments of pharmacy and medical records of the following institutions. Grant Support: In part by a contract with the Syntex Corporation (data collection), National Institutes of Health (NIH) training grant DK-07006, center grant DK-45191 from the NIH, and administrative and educational funds from the DCI RED Fund (research). Requests for Reprints: Harold I. Feldman, MD, MS, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Medical Center, 423 Guardian Drive, 720 Blockley Hall, Philadelphia, PA 19104-6021. Current Author Addresses: Dr. Feldman: Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Medical Center, 423 Guardian Drive, 720 Blockley Hall, Philadelphia, PA 19104-6021.


Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1997;126(3):193-199. doi:10.7326/0003-4819-126-3-199702010-00003
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Background: Acute renal failure has been associated with parenteral ketorolac tromethamine, but the risk that is associated with this therapy has not been quantified.

Objective: To compare the risk for acute renal failure associated with ketorolac with that associated with opioids.

Design: Retrospective cohort study.

Setting: 35 hospitals in or near Philadelphia.

Patients: Patients receiving 10 219 courses of parenteral ketorolac and patients receiving 10 145 courses of parenteral opioids.

Measurements: Acute renal failure was defined by 1) an increase in the serum creatinine concentration of 50% or more and 2) either an absolute increase of 44.2 µmol/L or more for concentrations that were less than 132.6 µmol/L at baseline or an absolute increase of 88.4 µmol/L or more for concentrations that were 132.6 µmol/L or more at baseline. In addition, a secondary definition required a diagnosis by a physician.

Results: The overall incidence of acute renal failure was 1.1% after therapy with either ketorolac or opioids. Multivariate-adjusted rate ratios comparing ketorolac with opioids for acute renal failure were 1.09 (95% CI, 0.83 to 1.42) overall, 1.00 (CI, 0.76 to 1.33) for less than 5 days of therapy, and 2.08 (CI, 1.08 to 4.00; P = 0.03) for more than 5 days of therapy. Similar results were obtained when the secondary definition of acute renal failure was used.

Conclusions: Overall, acute renal failure was uncommon in this hospitalized population. Compared with opioids, ketorolac administered for 5 days or less did not increase the rate of renal failure. However, among patients who were treated with analgesics for more than 5 days, ketorolac may be associated with an elevated rate of acute renal failure.

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