Is ketorolac (Toradol) safe for use in pediatric patients under 2 years of age, specifically a 1-year-old patient?

Ketorolac Safety in 1-Year-Old Patients

Ketorolac is NOT safe for use in a 1-year-old patient and should be avoided. The FDA drug label explicitly states that "ketorolac tromethamine tablets are not indicated for use in pediatric patients" and that "the safety and effectiveness of ketorolac tromethamine tablets in pediatric patients below the age of 17 have not been established" 1.

FDA Contraindications and Age Restrictions

• The FDA has not approved ketorolac for use in children under 17 years of age, making its use in a 1-year-old off-label and not recommended 1
• The drug label specifically states that ketorolac tablets are "not indicated for use in pediatric patients" 1
• While some older research literature from the 1990s suggested ketorolac could be used in children ≥1 year of age 2, this predates current FDA labeling restrictions that explicitly exclude pediatric use 1

Critical Safety Concerns in Young Children

Renal Toxicity Risk

• Young children with marginal kidney function are at particularly elevated risk for acute kidney injury when receiving ketorolac 3, 4
• Infants and very young children have immature renal function, making them more vulnerable to NSAID-induced nephrotoxicity 4

Pharmacokinetic Differences

• Children have a 2-fold increased volume of distribution and higher plasma clearance of ketorolac compared to adults, which complicates dosing in this age group 2
• Despite these differences, the elimination half-life remains similar, but the lack of FDA-approved pediatric dosing guidelines makes safe administration uncertain 2

Bleeding Risk

• Ketorolac reversibly inhibits platelet function and can increase bleeding time, which is particularly concerning in young children undergoing surgical procedures 2, 5
• The FDA drug label warns about increased risk of bleeding complications, especially when combined with anticoagulants 1

Evidence Quality and Limitations

• The available research on ketorolac in children is of very low quality and primarily involves older children (mean ages ranging from 1 year to 13.9 years), not specifically 1-year-olds 6
• A 2018 Cochrane systematic review concluded that "the efficacy and safety of ketorolac in treating postoperative pain in children were both uncertain" and that "the evidence was insufficient to support or reject its use" 6
• Most pediatric studies excluded infants under 1 year of age, and the one study that mentioned use in children ≥1 year was from 1997 and stated "ketorolac is not recommended for use in infants aged <1 year" 2

Safer Alternative Analgesics for Young Children

First-Line Options

• Acetaminophen (paracetamol) should be the first-line analgesic for pain and fever management in 1-year-old patients 7
• Ibuprofen is a safer NSAID alternative if anti-inflammatory effects are needed, as it has better-established safety data in young children 3, 7

For Postoperative Pain

• NSAIDs as a class (particularly ibuprofen) have been shown to be safe and effective for postoperative pain in children, without increased bleeding risk in most surgical contexts 3
• Regional anesthesia techniques should be considered as part of an opioid-sparing regimen when appropriate 3

Clinical Bottom Line

Do not use ketorolac in a 1-year-old patient. The FDA has not approved this medication for pediatric use, the safety profile is uncertain in this age group, and safer alternatives (acetaminophen, ibuprofen) are readily available with well-established pediatric dosing and safety data 1, 7. The lack of FDA approval, combined with very low-quality evidence and specific renal toxicity concerns in young children, makes ketorolac an inappropriate choice for this patient population 4, 6.