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Sponsored by: |
The University of Texas, Galveston |
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Information provided by: | The University of Texas, Galveston |
ClinicalTrials.gov Identifier: | NCT00580151 |
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 |
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Pain Anxiety |
Drug: clonidine Drug: placebo |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | June 2009 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: clonidine
5 microgram per kilogram every 6 hours for 10 days
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2: Placebo Comparator |
Drug: placebo
1 dose every 6 hours
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Ages Eligible for Study: | 4 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Walter J. Meyer III, MD | (409) 747-8355 | wmeyer@utmb.edu |
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. |
Principal Investigator: | Walter J. Meyer III, MD | The University of Texas Medical Branch at Galveston |
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 |
Pain not controled by morphine Anxiety not controled by lorazepam |
Burns Lorazepam Morphine Clonidine Pain |
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 |