What is the recommended dosing regimen for ketorolac (Toradol) in pediatric patients?

Ketorolac Dosing for Pediatric Patients

For children aged 1 year and older undergoing surgery, administer ketorolac 0.5 mg/kg IV as an initial dose, followed by 0.5 mg/kg every 6 hours (maximum 90 mg/day), with treatment duration limited to 48 hours for IV administration or 7 days for oral dosing. 1

Age-Specific Contraindications

• Ketorolac is not recommended for infants under 1 year of age due to insufficient safety and efficacy data in this population 1
• One documented lethal idiosyncratic reaction to ketorolac occurred in an adult with mastocytosis, and ketorolac should be avoided in all children with mastocytosis 2

Standard Dosing Regimen

Intravenous Administration (Preferred Route)

• Initial dose: 0.5 mg/kg IV administered after completion of surgery 1, 3
• Maintenance: 0.5 mg/kg IV every 6 hours OR continuous infusion at 0.17 mg/kg/hour 1
• Maximum daily dose: 90 mg regardless of weight 1
• Maximum duration: 48 hours for IV administration 1

Oral Administration

• Dose: 0.25 mg/kg to maximum 1.0 mg/kg/day 1
• Maximum duration: 7 days 1
• Transition to oral dosing once patient can tolerate oral medications 1

Pharmacokinetic Justification

The 6-hour dosing interval is supported by robust pharmacokinetic data showing that 0.5 mg/kg every 6 hours maintains trough concentrations above the therapeutic threshold (0.37 mg/L) in children aged 9 months to 16 years 4. Body weight-normalized clearance (0.57 ± 0.17 mL/min/kg) and volume of distribution (113 ± 33 mL/kg) are similar across pediatric age groups 1-16 years and comparable to adult values 3. This means children do not require larger weight-adjusted doses or shorter dosing intervals than adults 3.

Route Selection

• Intramuscular injections are NOT recommended in children unless IV access is unavailable, due to pain and distress associated with IM administration 1
• IV route is strongly preferred during the immediate postoperative period 1

Clinical Efficacy Context

Ketorolac demonstrates analgesic efficacy equivalent to morphine and superior to codeine for postoperative pain in children 1. However, a 2018 Cochrane review found very low-quality evidence overall, with insufficient data to definitively support or reject its use, though individual studies showed statistically significant pain reduction versus placebo 5. The evidence quality limitations stem from small sample sizes and heterogeneous study designs, not from safety concerns 5.

Opioid-Sparing Effects

When combined with opioids, ketorolac produces marked opioid-sparing effects, reducing morphine consumption by approximately 1.58 mg IV morphine equivalents in the 0-4 hour postoperative period 5. This synergistic action improves pain relief quality while reducing opioid-related adverse effects including respiratory depression, nausea/vomiting, and ileus 1.

Safety Profile

Advantages Over Opioids

• No respiratory depression 1
• No association with nausea, vomiting, urinary retention, or sedation 1
• Faster recovery of bowel function after abdominal surgery compared to opioid-treated patients 1

Bleeding Risk Considerations

• Ketorolac causes reversible antiplatelet effects through thromboxane synthesis inhibition 1
• Bleeding time may be slightly increased but typically remains within normal values 1
• Conflicting evidence exists regarding post-tonsillectomy bleeding, but for other pediatric surgical procedures, numerous studies confirm no increased bleeding risk 1
• The 2018 Cochrane review found insufficient serious adverse events to conclude that bleeding risk is increased perioperatively 5

Monitoring Requirements

• No routine coagulation monitoring required for most surgical procedures 1
• Consider baseline PT/PTT only for procedures with expected significant blood loss 1

Important Clinical Caveats

• Rescue analgesia requirements: Approximately 55% of children receiving ketorolac still required rescue analgesia versus 64% receiving placebo, showing ketorolac alone may not provide complete pain control 5
• Sickle cell disease: One study failed to demonstrate synergistic analgesic effect when ketorolac (0.9 mg/kg IV) was added to morphine for vaso-occlusive crisis, though this may require larger studies 6
• Age-related dosing adjustments: Older children may require somewhat lower doses while infants and young children may require slightly higher doses to achieve equivalent pain relief, though the standard 0.5 mg/kg dose is appropriate across ages 1-16 years 1, 3