Safety of ketorolac in surgical neonates and infants 0 to 3 months old

J Pediatr Surg. 2011 Jun;46(6):1081-5. doi: 10.1016/j.jpedsurg.2011.03.031.


Background: Ketorolac is a nonsteroidal antiinflammatory drug widely used as an adjunct to postoperative pain control in adult and pediatric patients. Minimal safety data exist regarding the use of ketorolac in neonates.

Methods: The charts of 57 postsurgical neonates between 0 and 3 months of age were retrospectively reviewed for bleeding events associated with ketorolac. Data included gestational age (GA), corrected gestational age (CGA) at the time of ketorolac, serum creatinine, platelet count, urine output (in milliliters per kilogram per hour), concomitant medications, enteral feeds, number of ketorolac doses, and surgical procedure performed.

Results: Of 57 patients, 10 (17.2%) demonstrated a bleeding event. Mean CGA and serum creatinine for those with bleeding events was 39.4 weeks (P = .69) and 0.64 mg/dL (P = .03), respectively. Patients with a bleeding event received ketorolac at a mean of 20.7 days of life with 70% receiving the drug at less than 14 days of age, whereas those without a bleeding event received ketorolac at a mean of 31.9 days (P = .04). Bleeding events correlated with glomerular filtration rate of less than 30 mL/min/1.73 m(2) or concomitant medications in all but 1 patient.

Conclusions: Infants younger than 21 days and less than 37 weeks CGA are at significantly increased risk for bleeding events and should not be candidates for ketorolac therapy.

Publication types

  • Comparative Study

MeSH terms

  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Cohort Studies
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Infant
  • Infant, Newborn
  • Infusions, Intravenous
  • Ketorolac / administration & dosage*
  • Ketorolac / adverse effects
  • Kidney Function Tests
  • Male
  • Pain, Postoperative / drug therapy*
  • Pain, Postoperative / prevention & control
  • Postoperative Care / methods
  • Postoperative Hemorrhage / chemically induced
  • Postoperative Hemorrhage / epidemiology*
  • Reference Values
  • Retrospective Studies
  • Risk Assessment
  • Surgical Procedures, Operative / methods
  • Treatment Outcome


  • Anti-Inflammatory Agents, Non-Steroidal
  • Ketorolac