The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Anxiety

Intervention / Treatment
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* Drug: clonidine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: clonidine<br>* 3-5 microgram per kilogram every 6 hours for 10 days<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* 1 dose every 6 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Reduction | 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. | Average of the 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Reduction | 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. | Average of the 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain not controled by morphine, Anxiety not controled by lorazepam