CompletedN/Aketamine

Ketamine Pharmacokinetics in Children Having Heart Surgery

Sponsored by Arkansas Children's Hospital Research Institute

NCT ID
NCT00598195
Target Enrollment
18 participants
Start Date
2006-06
Est. Completion
2009-12

About This Study

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.

Conditions Studied

C.Surgical Procedure; Cardiac

Interventions

  • Ketamine

Eligibility

Age:1 Day - 6 Years
Healthy Volunteers:No
View full eligibility 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

Study Locations (1)

Arkansas Children's Hospital
Little Rock, Arkansas, United States

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source