Ketorolac (Toradol) is a potent nonsteroidal anti-inflammatory drug (NSAID) used for the short-term management of moderately severe acute pain, often post-operatively. As a non-narcotic agent, it provides analgesia comparable to opioids. Ketorolac works by inhibiting the production of prostaglandins, compounds that promote inflammation, fever, and pain. While effective in adults, its use in younger patients is strictly limited due to metabolic differences and potential adverse effects.
Minimum Age Requirements and Contraindications
Systemic ketorolac use in the pediatric population is generally reserved for children older than two years in clinical practice. This is considered “off-label,” as the Food and Drug Administration (FDA) has not established safety and efficacy for patients under 17 years old. The two-year minimum is cited because infants and young toddlers have immature renal function. Their kidneys are less efficient at clearing the medication, which can lead to higher drug concentrations and an increased risk of toxicity.
Ketorolac can compromise kidney blood flow, making caution regarding renal development necessary. Absolute contraindications include pre-existing renal impairment, such as a glomerular filtration rate (GFR) below 30 mL/min. Patients with confirmed or suspected hypovolemia or severe dehydration are also strictly excluded. Hypovolemia significantly increases the risk of acute kidney injury because the body relies on the prostaglandin pathway to maintain renal perfusion.
Other absolute contraindications relate to the drug’s effect on blood clotting and the gastrointestinal tract. Ketorolac inhibits platelet function and increases the risk of ulceration or perforation. Therefore, it must be avoided in patients with:
- Active bleeding
- A history of cerebrovascular bleeding
- Any known hemorrhagic diathesis
- A history of peptic ulcer disease or recent gastrointestinal bleeding
Pediatric Dosing Guidelines and Administration Routes
When ketorolac is used in pediatrics, dosing must be precisely calculated based on the patient’s body weight to ensure efficacy and safety. The standard approach involves weight-based dosing, typically starting at 0.5 milligrams per kilogram (mg/kg) per dose. The total dose must not exceed the maximum single dose limits, which are often capped at 15 mg for smaller children or the adult maximums for larger adolescents.
Intravenous (IV) and intramuscular (IM) injections are the common routes for initial treatment of moderate to severe pain, such as following surgery. The IV route is generally preferred because it offers the most predictable absorption and rapid onset of action, which is important for rapid pain control. IM injection is often avoided unless IV access is unavailable, as it can be a painful procedure for a child.
Oral ketorolac is reserved for transitioning the patient away from the injectable form, typically once the patient can tolerate liquids and solid food. Regardless of the route, clinicians must strictly adhere to the dosing schedule, often every six hours. The maximum daily dose, which ranges from 60 mg to 90 mg depending on the child’s size and institutional protocol, must never be exceeded.
Safety Monitoring and Maximum Treatment Duration
The maximum duration of ketorolac therapy is a stringent safety measure mandated to prevent increased adverse events. Total combined use—regardless of the route (IV, IM, or oral)—must not exceed five days. This time limit is enforced because the risk of serious complications, particularly gastrointestinal bleeding and acute renal failure, increases significantly with prolonged exposure.
Safety monitoring requires close clinical oversight specific to the child’s physiological status. Hydration status must be continuously monitored, as volume depletion is a major risk factor for kidney injury. Clinicians also track urine output carefully, since a reduction can signal declining renal function. For high-risk children or those requiring the drug for close to the maximum duration, baseline and follow-up renal function tests, such as Blood Urea Nitrogen (BUN) and Creatinine levels, are often necessary.
Patients must be transitioned to an alternative, less potent analgesic as they move past the most intense acute pain phase. This transition, often to medications like oral acetaminophen or ibuprofen, must occur well within the five-day window. The goal is to use the lowest effective dose of ketorolac for the shortest possible duration, followed by a rapid switch to lower-risk pain relievers.