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: August 30, 2014
Last verified: August 2014
  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

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of Ketamine in Infants and Children

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Age-dependent pharmacokinetic parameters [ Time Frame: 5-720 minutes ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
Sponsors and Collaborators
Stanford University
University of Colorado, Denver
Investigators
Principal Investigator: Chandra Ramamoorthy, MBBS, FRCA Stanford University
  More Information

No publications provided

Responsible Party: Chandra Ramamoorthy, Professor of Anesthesia, Stanford University
ClinicalTrials.gov Identifier: NCT00553839     History of Changes
Other Study ID Numbers: 3384
Study First Received: November 5, 2007
Last Updated: August 30, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014