Official Title: “The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children”

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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Placebo Control, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Study Primary Completion Date: June 2012

Intervention(s) in this Clinical Trial

• Drug: clonidine
  • 5 microgram per kilogram every 6 hours for 10 days
• Drug: placebo
  • 1 dose every 6 hours

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• pain reduction
  • Time Frame: 10 days
    Safety Issue?: No

Secondary Measures

• anxiety reduction
  • Time Frame: 10 days
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: 20 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: The University of Texas, Galveston

Overall Clinical Trial Officials and Contacts

Walter J. Meyer III, MD Principal Investigator The University of Texas Medical Branch at Galveston  

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

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00580151

Study ID Number: 04-101

ClinicalTrials.gov Identifier: NCT00580151

Health Authority: United States: Food and Drug Administration