Pharmacokinetics of Ketamine in Infants and Children

This study has been completed.
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Chandra Ramamoorthy, Stanford University
ClinicalTrials.gov Identifier:
NCT00553839
First received: November 5, 2007
Last updated: February 4, 2016
Last verified: August 2014

November 5, 2007
February 4, 2016
July 2007
January 2009   (final data collection date for primary outcome measure)
  • Total Clearance and Intercompartmental Clearance [ Time Frame: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus. ] [ Designated as safety issue: No ]

    pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age.

    Total Clearance and Intercompartmental Clearance were analyzed using Bootstrap model.

  • Central and Peripheral Volume of Distribution [ Time Frame: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus. ] [ Designated as safety issue: No ]

    pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age.

    Central and Peripheral Volume of Distribution were analyzed using Bootstrap model.

  • Residual Error [ Time Frame: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus. ] [ Designated as safety issue: No ]

    pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age.

    Residual Error was analyzed using Bootstrap model.

Age-dependent pharmacokinetic parameters [ Time Frame: 5-720 minutes ]
Complete list of historical versions of study NCT00553839 on ClinicalTrials.gov Archive Site
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Pharmacokinetics of Ketamine in Infants and Children
Pharmacokinetics of Ketamine in Infants and Children
Dosing of medications is based on the plasma level achieved with a given dose and how long the medicine remains in the body. This study is called pharmacokinetics-that is, what the body does to the medication. Ketamine is an intravenous medication used for anesthesia and sedation in children. However the pharmacokinetics of Ketamine has not been systematically studied. We propose to study the pharmacokinetics of ketamine in different age groups of children ranging from infants to teenagers.
This is an open label study that will be conducted in infants and children presenting for procedures (eg., surgery or cardiac catheterization) at Stanford and Lucile Packard Children's hospital in California and at The Children's Hospital in Denver, CO. Patients with abnormal kidney or liver functions will be excluded from the study as the dysfunction in these organs affects the clearance of medications from the body and affects dosing. Preterm neonates will also be excluded. All patients will be premedicated and anesthetised at the discretion of the anesthesia faculty providing clinical care for the child. Once the patient's procedure is underway, a 0.5 cc blood sample will be drawn from an intravenous line. This is the preload blood sample (T0). Following this a 2mg/kg intravenous bolus of Ketamine will be administered over 5 minutes (this is the usual dose and manner in which ketamine is administered). Five minutes after the bolus, timed blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus. (Total 14 blood samples; total blood required is 7 mls for the entire study). When the procedure is completed the anesthesiologist will awaken the patient as per their usual practice. Blood samples that still need drawing will be done in the post-anesthesia recovery room or intensive care or ward-any location where the patient is likely to remain after the surgery.
Interventional
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Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
The Pk of IV Ketamine in Children With Heart Disease
Drug: ketamine hydrochloride
Open label pharmacokinetic study to be conducted in infants and children presenting for medical procedures (eg., surgery or cardiac catheterization). After the start of the procedure, a 0.5 cc preload blood sample (T0) will be drawn from an IV line. Then a 2 mg/kg IV bolus of Ketamine will be administered over 5 minutes. Timed 0.5 ml blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.
Ketamine
Then a 2 mg/kg IV bolus of Ketamine hydrochloride will be given as part of general anesthesia for procedure
Intervention: Drug: ketamine hydrochloride
Elkomy MH, Drover DR, Hammer GB, Galinkin JL, Ramamoorthy C. Population pharmacokinetics of ketamine in children with heart disease. Int J Pharm. 2015 Jan 15;478(1):223-31. doi: 10.1016/j.ijpharm.2014.11.026. Epub 2014 Nov 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Term infants (38 weeks gestation)and infants and children up to age 18 years.
  • Patients who require procedures that necessitate at least 8 hours in the hospital and those being admitted after procedure will be eligible to participate.
  • Patients who will receive ketamine as part of their standard anesthesia regimen.

Exclusion Criteria:

  • Preterm neonates
  • Liver Disease
  • Kidney disease
  • Heart failure
  • Sepsis
  • Patients receiving anticonvulsants or barbiturates
Both
up to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00553839
3384
No
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Chandra Ramamoorthy, Stanford University
Stanford University
University of Colorado, Denver
Principal Investigator: Chandra Ramamoorthy, MBBS, FRCA Stanford University
Stanford University
August 2014

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