Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Information provided by:
Stanford University Identifier:
First received: April 7, 2009
Last updated: July 27, 2011
Last verified: July 2011

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
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


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

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
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 identifier: NCT01100138

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

No publications provided

Responsible Party: Chandra Ramamoorthy, Stanford University School of Medicine 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:
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 25, 2014