At what age can ketamine (ketophol) be used for sedation in children?

Ketamine for Pediatric Sedation: Minimum Age Guidelines

Ketamine can be safely used for procedural sedation in children as young as 3 months of age, though the FDA label notes that safety and effectiveness have not been formally established below age 16. 1

Evidence-Based Age Recommendations

The published evidence demonstrates safe ketamine use in infants as young as 1-3 months:

• Large prospective studies have documented ketamine sedation in children from birth to 21 years, with a median age of 60 months and adverse event rates comparable across age groups 2
• A multicenter Canadian study of 6,295 children found no increased risk of serious adverse events in children ≤2 years compared to older children, with 90% of the young cohort being 13-24 months old 3
• Multiple guideline-level studies from the American College of Emergency Physicians included children as young as 14 months with excellent safety profiles 4

Critical Safety Considerations by Age

Younger children have specific risk factors that require attention:

• Laryngospasm risk increases with decreasing age: 13.9% in children <6 years versus 3.6% in children ≥6 years, though this data comes from higher-risk gastroenterology procedures 4
• In emergency department procedural sedation, laryngospasm rates are much lower: 0.9-1.4% across all pediatric ages 4
• Recovery agitation is more common in younger children but is generally mild and self-limited 4

Dosing Adjustments for Young Children

Ketamine dosing must be increased for younger patients due to pharmacokinetic differences:

• For IV ketamine: 2-year-olds require 2.125 mg/kg versus 1.5 mg/kg for adults to achieve equivalent sedation 5
• For IM ketamine: standard dosing is 4 mg/kg initial dose, with repeat doses of 2-4 mg/kg as needed 4
• Infusion rates also increase with decreasing age: 3.5 mg/kg/hour for 2-year-olds versus 2.5 mg/kg/hour for adults 5

FDA Label Caveats

The FDA label includes important warnings about pediatric use:

• Safety and effectiveness have not been formally established in children below age 16 1
• Published juvenile animal studies show neuroapoptosis with prolonged ketamine exposure during periods of rapid brain development, particularly in children <3 years 1
• The clinical significance of these animal findings remains unclear, and healthcare providers must balance procedural benefits against theoretical neurodevelopmental risks 1

Practical Clinical Approach

For children 13-24 months and older, ketamine is well-established as safe and effective:

• This age group comprised 90% of the ≤2 year cohort in the largest safety study, with no increased adverse events 3
• Ketamine was used most commonly for laceration repair in young children (47.6% of cases) 3

For infants 3-12 months, ketamine can be used but requires:

• Enhanced airway monitoring and immediate availability of airway management equipment 4, 2
• Consideration of the theoretical neurodevelopmental concerns from animal studies 1
• Recognition that most published safety data includes relatively few infants in this age range 2, 3

For infants <3 months, ketamine use should be reserved for situations where benefits clearly outweigh risks, as minimal safety data exists in this age group despite the drug being used from birth in some series. 2