Pharmacokinetics of Ketamine in Infants and Children



Status:Completed
Conditions:Chronic Pain, Hospital
Therapuetic Areas:Musculoskeletal, Other
Healthy:No
Age Range:Any - 17
Updated:4/21/2016
Start Date:July 2007
End Date:January 2009

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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.

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.

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
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Denver, Colorado 80218
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Palo Alto, California 94304
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Palo Alto, CA
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