Clinical trial NCT00553839: Pharmacokinetics of Ketamine in Infants and Children
Official title: Pharmacokinetics of Ketamine in Infants and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Pk of IV Ketamine in Children With Heart Disease
Keywords: anesthesia
children
ketamine
pharmacokinetics
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2007-11-06
Enrollment: 21
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Clearance and Intercompartmental Clearance
timeFrame: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.
measure: Central and Peripheral Volume of Distribution
timeFrame: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.
measure: Residual Error
timeFrame: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
city: Denver
country: United States
facility: The Children's Hospital
state: Colorado
Study officials:
affiliation: Stanford University
name: Chandra Ramamoorthy, MBBS, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elkomy MH, Drover DR, Hammer GB, Galinkin JL, Ramamoorthy C. Population pharmacokinetics of ketamine in children with heart disease. Int J Pharm. 2015 Jan 15;478(1):223-231. doi: 10.1016/j.ijpharm.2014.11.026. Epub 2014 Nov 13.