Pharmacokinetics of Ketamine in Infants and Children

This study has been completed.
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Chandra Ramamoorthy, Stanford University
ClinicalTrials.gov Identifier:
NCT00553839
First received: November 5, 2007
Last updated: February 4, 2016
Last verified: August 2014
Results First Received: February 4, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: The Pk of IV Ketamine in Children With Heart Disease
Intervention: Drug: ketamine hydrochloride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Single Group Assignment No text entered.

Participant Flow:   Overall Study
    Single Group Assignment  
STARTED     21  
COMPLETED     21  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Children between 6 months to 18 years of age with cardiac diseases in order to rationalize an effective 2-h anesthetic medication personalized based on cardiac function and age

Reporting Groups
  Description
Ketamine

Then a 2 mg/kg IV bolus of Ketamine hydrochloride will be given.

ketamine hydrochloride: 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.


Baseline Measures
    Ketamine  
Number of Participants  
[units: participants]
  21  
Age  
[units: years]
Mean (Standard Deviation)
  6.44  (4.59)  
Gender  
[units: participants]
 
Female     7  
Male     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Clearance and Intercompartmental Clearance   [ Time Frame: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus. ]

2.  Primary:   Central and Peripheral Volume of Distribution   [ Time Frame: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus. ]

3.  Primary:   Residual Error   [ Time Frame: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chandra Ramamoorthy, MBBS, FRCA
Organization: Stanford University
phone: 650-723-5728
e-mail: chandrar@stanford.edu


Publications of Results:

Responsible Party: Chandra Ramamoorthy, Stanford University
ClinicalTrials.gov Identifier: NCT00553839     History of Changes
Obsolete Identifiers: NCT01100138
Other Study ID Numbers: 3384
Study First Received: November 5, 2007
Results First Received: February 4, 2016
Last Updated: February 4, 2016
Health Authority: United States: Institutional Review Board