Ketamine Pharmacokinetics in Children Having Heart Surgery

NCT00598195 | Completed

• 1 other identifier: 57839
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

C.Surgical Procedure; Cardiac

Keywords

Ketamine; Phamacokinetics; Cardiopulmonary bypass (CPB); ketamine/norketamine pharmacokinetic parameters

Outcome Measures

Primary Outcomes (1)

• To measure how long ketamine remains in blood after a single dose of ketamine is given (venous) to children undergoing cardiac surgery on cardiopulmonary bypass (CPB)compared to levels of children undergoing cardiac surgery without CPB.

  Length of time ketamine remains in the blood

Study Arms (1)

Ketamine Pharmacokinetics

NO INTERVENTION

The pharmacokinetic action of Ketamine used in Children having heart surgery.

Drug: Ketamine

Interventions

Ketamine DRUG

subject will then receive an intravenous bolus dose of ketamine 2 mg/kg as a rapid intravenous bolus, over less than two minutes just prior to CPB. In the non-CPB patients, ketamine will be administered just prior to the skin incision. All doses will be rounded to the nearest tenth of a milligram. Timed blood samples will be collected at standardized times after the completion of the ketamine infusion and samples will be obtained from an indwelling arterial line. Each blood sample for pharmacokinetic analysis will be 1 mL.

Ketamine Pharmacokinetics

Eligibility Criteria

• Age: 1 Day - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Adnan T Bhutta, M.D.

  Arkansas Children's Hospital and University of Arkansas for Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 21, 2008
• Study Start: June 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 27, 2013

Record last verified: 2013-02

Locations

US (1)