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Trial record 53 of 326 for:    clonidine

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

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ClinicalTrials.gov Identifier: NCT00580151
Recruitment Status : Terminated (Closed due to no response from PI to IRB)
First Posted : December 24, 2007
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Pain
Anxiety
Interventions Drug: clonidine
Drug: placebo
Enrollment 9
Recruitment Details Patients recruited in the medical clinic. Recruitment occured between 11/10/04-7/16/05.
Pre-assignment Details All participants were eligible to participate in the study.
Arm/Group Title Experimental Group Control Group
Hide Arm/Group Description clonidine : 3-5 microgram per kilogram every 6 hours for 10 days placebo : 1 dose every 6 hours
Period Title: Overall Study
Started 9 0
Completed 9 0
Not Completed 0 0
Arm/Group Title Experimental Group Control Group Total
Hide Arm/Group Description clonidine : 3-5 microgram per kilogram every 6 hours for 10 days placebo : 1 dose every 6 hours Total of all reporting groups
Overall Number of Baseline Participants 9 0 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 0 participants 9 participants
<=18 years 9 9
Between 18 and 65 years 0 0
>=65 years 0 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 0 participants 9 participants
7.8  (3.2) 7.8  (3.2)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 0 participants 9 participants
Female 1 1
Male 8 8
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 0 participants 9 participants
9 9
1.Primary Outcome
Title Pain Reduction
Hide Description The scale name is "FACES" (Faces Pain Rating Scale). Subjects were asked "rate your WORST PAIN today" (0 = no pain at all, 1-4 = mild pain, 5-6 = moderate pain, 7-9 = severe pain, 10 = excruciating pain). The Faces Pain Rating Scale should be collected every day and then averaged.
Time Frame Average of the 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Determined by the number of patients recruited.
Arm/Group Title Experimental Group Control Group
Hide Arm/Group Description:
clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
placebo : 1 dose every 6 hours
Overall Number of Participants Analyzed 9 0
Mean (Full Range)
Unit of Measure: units on a scale
.73
(0 to 4)
2.Secondary Outcome
Title Anxiety Reduction
Hide Description The "Fear Thermometer" measures how much fear subject is currently having. (0=None, 1= A little bit, 2= Some, 3= A lot, 4= Very, very much). The average of daily Value for 10 days.
Time Frame Average of the 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients analyzed were all patients consented.
Arm/Group Title Experimental Group Control Group
Hide Arm/Group Description:
clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
placebo : 1 dose every 6 hours
Overall Number of Participants Analyzed 9 0
Mean (Full Range)
Unit of Measure: units on a scale
.76
(0 to 4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Group Control Group
Hide Arm/Group Description clonidine : 3-5 microgram per kilogram every 6 hours for 10 days placebo : 1 dose every 6 hours
All-Cause Mortality
Experimental Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Walter Meyer, M.D.
Organization: University of Texas-Galveston
Phone: 409-770-6718
EMail: wmeyer@utmb.edu
Layout table for additonal information
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 )
First Submitted: December 18, 2007
First Posted: December 24, 2007
Results First Submitted: February 8, 2013
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015