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)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston Identifier:
First received: December 18, 2007
Last updated: February 10, 2015
Last verified: February 2015
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
Drug: clonidine
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Pain Reduction [ Time Frame: Average of the 10 days ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Anxiety Reduction [ Time Frame: Average of the 10 days ] [ Designated as safety issue: No ]
    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.

Enrollment: 9
Study Start Date: June 2004
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: clonidine
3-5 microgram per kilogram every 6 hours for 10 days
Placebo Comparator: 2 Drug: placebo
1 dose every 6 hours


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

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
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Please refer to this study by its identifier: NCT00580151

United States, Texas
Shriners Hospital for Children; Shriners Burns Hospital
Galveston, Texas, United States, 77550
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Principal Investigator: Walter J. Meyer III, MD The University of Texas Medical Branch at Galveston
  More Information

No publications provided

Responsible Party: The University of Texas Medical Branch, Galveston Identifier: NCT00580151     History of Changes
Other Study ID Numbers: 04-101, IFFA
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

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 25, 2015