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Oral Ketamine for Control of Chronic Pain in Children (KETA-2011)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Korones, University of Rochester
ClinicalTrials.gov Identifier:
NCT01369680
First received: May 23, 2011
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
Results First Received: October 24, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Pain
Intervention: Drug: Ketamine

  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
Recruitment began in June 2011 and closed in April 2012. Patients were referred by their primary pain physician.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ketamine 0.25 mg/kg/Dose Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
Ketamine 0.5 mg/kg/Dose Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
Ketamine 1 mg/kg/Dose Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
Ketamine 1.5 mg/kg/Dose Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.

Participant Flow:   Overall Study
    Ketamine 0.25 mg/kg/Dose     Ketamine 0.5 mg/kg/Dose     Ketamine 1 mg/kg/Dose     Ketamine 1.5 mg/kg/Dose  
STARTED     3     3     3     3  
COMPLETED     3     3     2     1  
NOT COMPLETED     0     0     1     2  
Lost to Follow-up                 0                 0                 1                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Ketamine 0.25 mg/kg/Dose Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
Ketamine 0.5 mg/kg/Dose Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
Ketamine 1 mg/kg/Dose Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
Ketamine 1.5 mg/kg/Dose Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
Total Total of all reporting groups

Baseline Measures
    Ketamine 0.25 mg/kg/Dose     Ketamine 0.5 mg/kg/Dose     Ketamine 1 mg/kg/Dose     Ketamine 1.5 mg/kg/Dose     Total  
Number of Participants  
[units: participants]
 		  3     3     3     3     12  
Age  
[units: participants]
 		         
<=18 years     2     3     3     3     11  
Between 18 and 65 years     1     0     0     0     1  
>=65 years     0     0     0     0     0  
Gender  
[units: participants]
 		         
Female     3     3     2     1     9  
Male     0     0     1     2     3  
Region of Enrollment  
[units: participants]
 		         
United States     3     3     3     3     12  



  Outcome Measures
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1.  Primary:   Number of Participants Tolerating Dose   [ Time Frame: Up to 2 weeks ]
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2.  Secondary:   Neurocognitive Effect   [ Time Frame: At 14 weeks ]
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3.  Secondary:   Norketamine Cmax (Measured in ng/mL).   [ Time Frame: At week 1 ]
  Show Outcome Measure 3

4.  Secondary:   Pain Control   [ Time Frame: Week 2 ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
Three subjects were lost to follow-up, limiting the data available for neuro-cognitive assessment at the last visit.  


Results Point of Contact:  
Name/Title: Dr. Amy-Lee Bredlau
Organization: Medical University of South Carolina
phone: 843-792-2957 ext 62872
e-mail: bredlau@musc.edu


Publications:


Responsible Party: David Korones, University of Rochester
ClinicalTrials.gov Identifier: NCT01369680     History of Changes
Other Study ID Numbers: KETA-2011
Study First Received: May 23, 2011
Results First Received: October 24, 2012
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board