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

April 7, 2009
July 27, 2011
April 2008
December 2011   (final data collection date for primary outcome measure)
Pharmacokinetics [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01100138 on ClinicalTrials.gov Archive Site
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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.
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.

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Interventional
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Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
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
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.
Intervention: Drug: Ketamine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01100138
SU-04092008-1095, 3384
Not Provided
Chandra Ramamoorthy, Stanford University School of Medicine
Stanford University
Not Provided
Principal Investigator: Chandra Ramamoorthy Stanford University
Stanford University
July 2011

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