Oral Ketorolac is Not Approved for Pediatric Patients Under 17 Years of Age
Oral ketorolac should not be prescribed for a 4-year-old child with a toothache, as the FDA explicitly states that oral formulation is not approved for patients under 17 years of age. 1
FDA Labeling and Age Restrictions
- The FDA drug label clearly indicates that ketorolac tablets are "Oral not approved" for patients under 17 years of age 1
- The oral formulation is only indicated as continuation therapy following IV or IM dosing in adults, not as initial treatment 1
- Even in approved adult populations (≥17 years), oral ketorolac requires prior parenteral administration and total treatment duration cannot exceed 5 days 1
Pediatric Use Considerations from Research
While research studies have evaluated ketorolac in pediatric populations, these investigations focused on intravenous administration in postoperative settings, not oral dosing for outpatient dental pain:
- Intravenous ketorolac at 0.5 mg/kg followed by 1.0 mg/kg every 6 hours (maximum 90 mg/day for 48 hours) has been studied in children for postoperative pain 2
- These studies specifically excluded infants under 1 year and were conducted in controlled hospital settings with close monitoring 2
- The pharmacokinetics in children differ significantly from adults, with 2-fold higher volume of distribution and increased clearance requiring higher relative dosing 2
Critical Safety Concerns
A lethal idiosyncratic reaction to ketorolac occurred in one adult with mastocytosis, leading to recommendations to avoid ketorolac entirely in both adults and children with this condition 3. This underscores the serious safety profile of this medication.
- Ketorolac carries risks of gastrointestinal bleeding, operative site bleeding, and acute renal failure, with risk increasing markedly with high dosages, prolonged use beyond 5 days, and in elderly patients 4
- The drug has reversible antiplatelet effects that increase bleeding time 2
Recommended Alternatives for Pediatric Dental Pain
For a 4-year-old (approximately 16 kg) with toothache, consider age-appropriate alternatives:
- Naproxen: 5 to 7.5 mg/kg every 12 hours (80-120 mg every 12 hours for this child), which is supported by the European Society for Paediatric Anaesthesiology for acute pain conditions in children 5
- Standard pediatric analgesics such as ibuprofen or acetaminophen at weight-based dosing would be more appropriate first-line options