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Ketamine Pharmacokinetics in Children Having Heart Surgery

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ClinicalTrials.gov Identifier: NCT00598195
Recruitment Status : Completed
First Posted : January 21, 2008
Last Update Posted : February 27, 2013
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE December 26, 2007
First Posted Date  ICMJE January 21, 2008
Last Update Posted Date February 27, 2013
Study Start Date  ICMJE June 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2008)
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. [ Time Frame: Length of time ketamine remains in the blood ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Pharmacokinetics in Children Having Heart Surgery
Official Title  ICMJE Ketamine Pharmacokinetics in Children Undergoing Cardiac Surgery
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.

Detailed Description

The role of ketamine in pediatric anesthesia is well established. It is one of the most commonly used agents for conscious sedation in pediatrics. Its widespread use stems for its abrupt onset of action and brief duration of sedation. There is limited ketamine pharmacokinetic data in children and none to our knowledge in infants and young children who will be given an intravenous bolus dose before a surgical procedure that includes cardiopulmonary bypass.

Ketamine is marketed as a racemic mixture (50:50 mixture of S- and R-ketamine enantiomers).

Ketamine undergoes N-demethylation (CYP3B6, 2C9, and 3A4) to its primary active metabolite,norketamine, with minor inactive metabolites, dehydroxynorketamine, generated secondary to direct oxidation. Ketamine exhibits a high intrinsic clearance with hepatic clearance dependent on hepatic blood flow under normal circumstances. One inherent disadvantage associated with the use of cardiopulmonary bypass (CPB) is the potential for organ dysfunction post-operatively.

We propose an open-label controlled study describing the disposition of ketamine in 28 infants and children who will be undergoing cardiac surgery with (n=16) and without (n=12) CPB. We anticipate that cardiopulmonary bypass alters the pharmacokinetics of ketamine.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE C.Surgical Procedure; Cardiac
Intervention  ICMJE Drug: Ketamine
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.
Study Arms  ICMJE No Intervention: Ketamine Pharmacokinetics
The pharmacokinetic action of Ketamine used in Children having heart surgery.
Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2011)
18
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2008)
28
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00598195
Other Study ID Numbers  ICMJE 57839
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arkansas Children's Hospital Research Institute
Study Sponsor  ICMJE Arkansas Children's Hospital Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adnan T Bhutta, M.D. Arkansas Children's Hospital and University of Arkansas for Medical Sciences
PRS Account Arkansas Children's Hospital Research Institute
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP