Gregory Hammer
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.
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Ketamine
Phase:
N/AEligibility
Ages Eligible for Study:
1 days to 17 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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.
Key Exclusion Criteria:
Preterm neonates
Liver Disease
Kidney disease
Heart failure
Sepsis
Patients receiving anticonvulsants or barbiturates
Additional Study Details
Official Title:
Pharmacokinetics of Ketamine in Infants and ChildrenAnticipated start date:
4/1/2008Lead Sponsor:
Stanford UniversityInvestigator(s):
- Gregory Hammer
- Chandra Ramamoorthy
- Hong Cao
- Carol A. Cohane
- Anthea F. Buchin
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
PharmacokineticsPrimary Outcomes:
- PK
Secondary Outcomes:
- safety
Total Number to be Enrolled:
50Total Number to be Enrolled at Stanford:
30More Information
Secondary ID(s):
- 3384
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
3/26/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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