Pharmacokinetics of Ketamine in Infants and Children

NCT00553839 | Completed Results

• 1 other identifier: 3384
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

The Pk of IV Ketamine in Children With Heart Disease

Keywords

anesthesia; children; ketamine; pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Total Clearance and Intercompartmental Clearance

  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.

  5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.

• Central and Peripheral Volume of Distribution

  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.

  5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.

• Residual Error

  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.

  5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.

Study Arms (1)

Ketamine

OTHER

Then a 2 mg/kg IV bolus of Ketamine hydrochloride will be given as part of general anesthesia for procedure

Drug: ketamine hydrochloride

Interventions

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.

Ketamine

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Preterm neonates
• Liver Disease
• Kidney disease
• Heart failure
• Sepsis
• Patients receiving anticonvulsants or barbiturates

Sponsors & Collaborators

• Stanford University: lead
• University of Colorado, Denver: collaborator

Study Sites (2)

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

The Children's Hospital

Denver, Colorado, 80218, United States

Location

Related Publications (1)

• 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.

  PMID: 25448584 RESULT

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Chandra Ramamoorthy, MBBS, FRCA
• Organization: Stanford University

chandrar@stanford.edu

650-723-5728

Study Officials

• Chandra Ramamoorthy, MBBS, FRCA

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 6, 2007
• Study Start: July 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: February 8, 2016
• Results First Posted: February 8, 2016

Record last verified: 2014-08

Locations

US (2)