Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
the Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children (clonidine)
This study is currently recruiting participants.
Verified by The University of Texas, Galveston, June 2008
Sponsored by: The University of Texas, Galveston
Information provided by: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00580151
  Purpose

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.


Condition Intervention
Pain
Anxiety
Drug: clonidine
Drug: placebo

MedlinePlus related topics: Anxiety Burns
Drug Information available for: Clonidine Lorazepam Clonidine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment
Official Title: The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children

Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • pain reduction [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • anxiety reduction [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2004
Estimated Study Completion Date: June 2009
Arms Assigned Interventions
1: Experimental Drug: clonidine
5 microgram per kilogram every 6 hours for 10 days
2: Placebo Comparator Drug: placebo
1 dose every 6 hours

  Eligibility

Ages Eligible for Study:   4 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580151

Contacts
Contact: Walter J. Meyer III, MD (409) 747-8355 wmeyer@utmb.edu

Locations
United States, Texas
Shriners hospital for Children; Shriners Burns Hospital Recruiting
Galveston, Texas, United States, 77550
Contact: Walter J. Meyer, M.D.     409-747-8355     wmeyer@utmb.edu    
Principal Investigator: Walter J. Meyer, M.D.            
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: Walter J. Meyer III, MD The University of Texas Medical Branch at Galveston
  More Information

Responsible Party: University of Texas Medical Branch ( Walter J. Meyer III, M.D. )
Study ID Numbers: 04-101, IFF 489030
Study First Received: December 18, 2007
Last Updated: June 6, 2008
ClinicalTrials.gov Identifier: NCT00580151  
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas, Galveston:
Pain not controled by morphine
Anxiety not controled by lorazepam

Study placed in the following topic categories:
Burns
Lorazepam
Morphine
Clonidine
Pain

Additional relevant MeSH terms:
Sympatholytics
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 13, 2009