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

NCT ID: NCT00580151

Last Updated: 2015-02-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2014-06-30

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.

Conditions

Pain; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

clonidine

Intervention Type: DRUG

3-5 microgram per kilogram every 6 hours for 10 days

2

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

1 dose every 6 hours

Interventions

clonidine

3-5 microgram per kilogram every 6 hours for 10 days

Intervention Type: DRUG

placebo

1 dose every 6 hours

Intervention Type: DRUG

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter J. Meyer III, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Medical Branch at Galveston

Locations

Shriners Hospital for Children; Shriners Burns Hospital

Galveston, Texas, United States

Countries

United States

Other Identifiers

IFFA

Identifier Type: OTHER

Identifier Source: secondary_id

04-101

Identifier Type: -

Identifier Source: org_study_id