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

Primary Purpose

Pain, Anxiety

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
clonidine
placebo
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain not controled by morphine, Anxiety not controled by lorazepam

Eligibility Criteria

4 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shriners Hospital for Children; Shriners Burns Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 18, 2007
Last Updated
February 10, 2015
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT00580151
Brief Title
The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children
Acronym
clonidine
Official Title
The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Closed due to no response from PI to IRB
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
Pain not controled by morphine, Anxiety not controled by lorazepam

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
clonidine
Intervention Description
3-5 microgram per kilogram every 6 hours for 10 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1 dose every 6 hours
Primary Outcome Measure Information:
Title
Pain Reduction
Description
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.
Time Frame
Average of the 10 days
Secondary Outcome Measure Information:
Title
Anxiety Reduction
Description
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.
Time Frame
Average of the 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter J. Meyer III, MD
Organizational Affiliation
The University of Texas Medical Branch at Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospital for Children; Shriners Burns Hospital
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States

12. IPD Sharing Statement

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

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