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Pharmacokinetics of Ketamine in Infants and Children

This study is currently recruiting participants.
Verified by Stanford University, November 2007

Sponsors and Collaborators: Stanford University
University of Colorado at Denver and Health Sciences Center
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00553839
  Purpose

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.


Condition Intervention
General Anesthesia
Sedation
Pain Management
Drug: ketamine hydrochloride

MedlinePlus related topics:   Anesthesia   

ChemIDplus related topics:   Ketamine    Ketamine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Basic Science, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics Study
Official Title:   Pharmacokinetics of Ketamine in Infants and Children

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Age-dependent pharmacokinetic parameters [ Time Frame: 5-720 minutes ]

Estimated Enrollment:   50
Study Start Date:   July 2007
Estimated Study Completion Date:   January 2009

Intervention Details:
    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.
Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553839

Contacts
Contact: Chandra Ramamoorthy, MBBS, FRCA     650-724-7093     chandrar@stanford.edu    
Contact: Nancy Federspiel, PhD     650-725-7512     nfeder@stanford.edu    

Locations
United States, California
Lucile Packard Children's Hospital     Recruiting
      Palo Alto, California, United States, 94304
      Contact: Chandra Ramamoorthy, MBBS, FRCA     650-724-7093     chandrar@stanford.edu    
      Contact: Nancy A Federspiel, PhD     650-725-7512     nfeder@stanford.edu    
      Principal Investigator: Chandra Ramamoorthy, MBBS, FRCA            
United States, Colorado
The Children's Hospital     Recruiting
      Denver, Colorado, United States, 80218
      Contact: Jeffrey L Galinkin, MD     303-869-3399     jeffrey.galinkin@uchsc.edu    
      Contact: Jeannie Zuk         zuk.jeannie@tchden.org    
      Principal Investigator: Jeffrey L. Galinkin, MD            

Sponsors and Collaborators
Stanford University
University of Colorado at Denver and Health Sciences Center

Investigators
Principal Investigator:     Chandra Ramamoorthy, MBBS, FRCA     Stanford University    
  More Information


Study ID Numbers:   3384
First Received:   November 5, 2007
Last Updated:   November 5, 2007
ClinicalTrials.gov Identifier:   NCT00553839
Health Authority:   United States: Institutional Review Board

Keywords provided by Stanford University:
ketamine  
pharmacokinetics  
neonates  
infants
children
pediatric

Study placed in the following topic categories:
Excitatory Amino Acids
Ketamine
Pain

Additional relevant MeSH terms:
Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Agents
Anesthetics, Dissociative
Pharmacologic Actions
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on October 07, 2008




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