N/A N=21 Basic Science

Pharmacokinetics of Ketamine in Infants and Children

The Pk of IV Ketamine in Children With Heart Disease

Bottom Line

View on ClinicalTrials.gov: NCT00553839 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcome: Primary: Total Clearance and Intercompartmental Clearance — 60.0; 70.8 L/h/70kg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ketamine hydrochloride (Drug)
Age: Pediatric
Sex: All
Sponsor: Stanford University
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Clearance and Intercompartmental Clearance	60.0; 70.8	—
PRIMARY Central and Peripheral Volume of Distribution	57.6; 149	—
PRIMARY Residual Error	16.1	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00553839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.