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Trial record 53 of 328 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

Tracking Information
First Submitted Date  ICMJE December 18, 2007
First Posted Date  ICMJE December 24, 2007
Results First Submitted Date  ICMJE February 8, 2013
Results First Posted Date  ICMJE February 23, 2015
Last Update Posted Date February 23, 2015
Study Start Date  ICMJE June 2004
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2015)
Pain Reduction [ Time Frame: Average of the 10 days ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Pain Reduction [ Time Frame: 10 days ]
Change History Complete list of historical versions of study NCT00580151 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2015)
Anxiety Reduction [ Time Frame: Average of the 10 days ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Anxiety Reduction [ Time Frame: 10 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children
Official Title  ICMJE The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children
Brief Summary Some of the children who suffer acute burn injury do not have adequate pain and anxiety management with the current regimen of scheduled opiates (morphine) and benzodiazepines (lorazepam). Other children have significant side effects or contraindications, such as constipation or over sedation, when taking these medications. Clonidine is known to reduce the need for morphine in the management of postoperative pain. The addition of clonidine to the pharmacological treatment of burn wound pain offers a possible adjunct to the standard opiate and benzodiazepines regimen. Clonidine has been used in children in both on a short-term basis (such as postoperative pain management) and on a long-term basis (such as the treatment of attention deficit hyperactivity disorder (ADHD)). This study tests the hypothesis that clonidine in a dose of 5 ug/kilo every 8 hours will be a useful adjunct to the management of pain and anxiety in the acutely burned child. All children will be treated by protocol with morphine (0.03mg/kilo) q4hr prn pain and lorazepam (0.03 mg/kilo) q 4 hours prn anxiety. In addition, after informed consent is obtained the children will be randomized to the addition clonidine or placebo. Pain and anxiety will be assessed using standard instruments blind to the medication being used on a daily basis Also the total dose of morphine and lorazepam during the 10 days of added clonidine or placebo will be recorded.. The pain rating, anxiety ratings, total morphine dose, and total lorazepam dose will be compared between the placebo and clonidine groups with a Student's t test. Once the blind is broken the child will be allowed to remain on the clonidine if it is beneficial. The second year of the grant will expand the age groups down to younger children and also begin to gain information about the effect of clonidine on the hypermetabolic state secondary to burn injury.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Anxiety
Intervention  ICMJE
  • Drug: clonidine
    3-5 microgram per kilogram every 6 hours for 10 days
  • Drug: placebo
    1 dose every 6 hours
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: clonidine
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 10, 2015)
9
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2007)
60
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pain not controled by morphine
  • Anxiety not controled by lorazepam
  • Burn injuries of 20% or greater
  • Burn type: scald or flame

Exclusion Criteria:

  • Small burn injury
  • Electrical burns
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00580151
Other Study ID Numbers  ICMJE 04-101
IFFA ( Other Identifier: International Firefighters Association )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The University of Texas Medical Branch, Galveston
Study Sponsor  ICMJE The University of Texas Medical Branch, Galveston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Walter J. Meyer III, MD The University of Texas Medical Branch at Galveston
PRS Account The University of Texas Medical Branch, Galveston
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP