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

Pain Clinical Trial

— clonidine  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00580151
• Other study ID #: 04-101
• Secondary ID: IFFA
• Status: Terminated
• Phase: N/A
• First received: December 18, 2007
• Last updated: February 10, 2015
• Start date: June 2004
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 20 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

Drug:
• clonidine
3-5 microgram per kilogram every 6 hours for 10 days
• placebo
1 dose every 6 hours

Locations

Country	Name	City	State
United States	Shriners Hospital for Children; Shriners Burns Hospital	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No