N/A
Completed N=21
Pharmacokinetics of Ketamine in Infants and Children
The Pk of IV Ketamine in Children With Heart Disease
Source: ClinicalTrials.gov NCT00553839 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Total Clearance and Intercompartmental Clearance — 60.0; 70.8 L/h/70kg
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.
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 | — |
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
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. Informational only — not medical advice.