Ketamine Pharmacokinetics in Children Having Heart Surgery
Completed · Not applicable
Conditions studied: C.Surgical Procedure; Cardiac
In brief
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.
Key facts
- Study ID
- NCT00598195
- Run by
- Arkansas Children's Hospital Research Institute
- People needed
- 18
- Starts
- 2006-06-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2013-02-27
Who can join
Age: 0 and older, up to 6. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≤ 6 years of age
- cardiac surgical procedure
- Indwelling arterial line or central venous line for blood sampling
You may not qualify if…
- 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
Where it is running
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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