pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age. Total Clearance and Intercompartmental Clearance were analyzed using Bootstrap model.
Pharmacokinetics of Ketamine in Infants and Children
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.
Intervention / Treatment
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Ketamine Hydrochloride (DRUG)Open label pharmacokinetic study to be conducted in infants and children presenting for medical procedures (eg., surgery or cardiac catheterization). After the start of the procedure, a 0.5 cc preload blood sample (T0) will be drawn from an IV line. Then a 2 mg/kg IV bolus of Ketamine will be administered over 5 minutes. Timed 0.5 ml 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.
Condition or Disease
- The Pk of IV Ketamine in Children With Heart Disease
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | up to 17 Years (Child) |
| Enrollment: | 21 (ACTUAL) |
| Funded by: | Other |
| Allocation: | N/A |
| Primary Purpose: | Basic Science |
Masking |
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Clinical Trial Dates
| Start date: | Jul 01, 2007 | |
|---|---|---|
| Primary Completion: | Jan 01, 2009 | ACTUAL |
| Completion Date: | Jan 01, 2009 | ACTUAL |
| Study First Posted: | Nov 06, 2007 | ESTIMATED |
| Results First Posted: | Feb 08, 2016 | ESTIMATED |
| Last Updated: | Feb 04, 2016 |
Sponsors / Collaborators
Lead Sponsor:
Stanford University
Responsible Party:
N/A
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.
Participant Groups
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Then a 2 mg/kg IV bolus of Ketamine hydrochloride will be given as part of general anesthesia for procedure
Eligibility Criteria
| Sex: | All |
|---|---|
| Maximum Age: | 17 |
| Age Groups: | Child |
| Healthy Volunteers: | Yes |
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
* 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
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pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age. Central and Peripheral Volume of Distribution were analyzed using Bootstrap model.
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pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age. Residual Error was analyzed using Bootstrap model.
More Details
| NCT Number: | NCT00553839 |
|---|---|
| Other IDs: | 3384 |
| Study URL: | https://clinicaltrials.gov/study/NCT00553839 |
Last updated: Sep 29, 2023