Ketamine Pharmacokinetics in Children Having Heart Surgery

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

What are the pharmacokinetics of ketamine in infants and children requiring ketamine for induction of anesthesia for cardiac surgery that requires CPB? Specific Aim 1: To determine the pharmacokinetic parameters of a single intravenous bolus dose of ketamine in infants and children undergoing cardiac surgery with and without CPB (cardio-pulmonary bypass).

Specific Aim 2: To describe the disposition of ketamine's primary active metabolite, norketamine,following a single intravenous bolus dose of ketamine in infants and children undergoing cardiac surgery with and without CPB.

Specific Aim 3: To determine the relationship between ketamine and norketamine pharmacokinetic parameters and age as well as CPB time.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arkansas Children's Hospital Research Institute
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• ≤ 6 years of age

• cardiac surgical procedure

• Indwelling arterial line or central venous line for blood sampling

Exclusion Criteria:

• patients with known hepatic dysfunction(>3 times normal AST & ALT)

• clinically significant alteration (as determined by the investigator) hemoglobin or hematocrit

• patients receiving medications known to be potent inhibitors or inducers of CYP3A4 and CYP2C19

• patients with significant malnutrition (< 1%tile for age-adjusted weight)

• patients enrolled in other studies that require frequent blood sampling during and after cardiac surgery

• any contraindication for ketamine administration

• ketamine administration within the previous 24 hours

• Patients with known history of pulmonary hypertension