The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children (clonidine)

This study has been terminated.
(Closed due to no response from PI to IRB)
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier:
NCT00580151
First received: December 18, 2007
Last updated: February 10, 2015
Last verified: February 2015
Results First Received: February 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Pain
Anxiety
Interventions: Drug: clonidine
Drug: placebo

  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
Patients recruited in the medical clinic. Recruitment occured between 11/10/04-7/16/05.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants were eligible to participate in the study.

Reporting Groups
  Description
Experimental Group clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
Control Group placebo : 1 dose every 6 hours

Participant Flow:   Overall Study
    Experimental Group     Control Group  
STARTED     9     0  
COMPLETED     9     0  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
Experimental Group clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
Control Group placebo : 1 dose every 6 hours
Total Total of all reporting groups

Baseline Measures
    Experimental Group     Control Group     Total  
Number of Participants  
[units: participants]
  9     0     9  
Age  
[units: participants]
     
<=18 years     9         9  
Between 18 and 65 years     0         0  
>=65 years     0         0  
Age  
[units: years]
Mean (Standard Deviation)
  7.8  (3.2)         7.8  (3.2)  
Gender  
[units: participants]
     
Female     1         1  
Male     8         8  
Region of Enrollment  
[units: participants]
     
United States     9         9  



  Outcome Measures
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1.  Primary:   Pain Reduction   [ Time Frame: Average of the 10 days ]

2.  Secondary:   Anxiety Reduction   [ Time Frame: Average of the 10 days ]


  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
No Adverse Events Recorded.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Walter Meyer, M.D.
Organization: University of Texas-Galveston
phone: 409-770-6718
e-mail: wmeyer@utmb.edu



Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00580151     History of Changes
Other Study ID Numbers: 04-101
IFFA ( Other Identifier: International Firefighters Association )
Study First Received: December 18, 2007
Results First Received: February 8, 2013
Last Updated: February 10, 2015
Health Authority: United States: Food and Drug Administration