Study of a Drug Called "Ketamine" and How Much is in the Bloodstream of Infants and Children Who Have Undergone Surgery. Ketamine is a standard-of- Care Medication Used in the Intensive Care Unit at Stanford for Sedation and Anesthesia.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01100138
First received: April 7, 2009
Last updated: July 27, 2011
Last verified: July 2011
  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
Pain
Drug: Ketamine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:
  • Pharmacokinetics [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine
Open label study of the pharmacokinetics of ketamine used during surgery. The dose will be standardized for all subjects at 2 mg/kg (IV) over 5 minutes, once the patient's surgery is underway.
Drug: Ketamine
2mg/kg intravenous dose of Ketamine will be administered over 5 minutes (this is the usual dose and manner in which ketamine is administered). This is a one-time dose.
Other Name: Ketalar, Ketaset, Ketanest

  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, but not including 18 years old.
  • 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: NCT01100138

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Chandra Ramamoorthy Stanford University
  More Information

No publications provided

Responsible Party: Chandra Ramamoorthy, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01100138     History of Changes
Other Study ID Numbers: SU-04092008-1095, 3384
Study First Received: April 7, 2009
Last Updated: July 27, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014