the Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children - Tabular View

Tracking Information

First Received Date ^ICMJE

December 18, 2007

Last Updated Date

February 12, 2009

Start Date ^ICMJE

June 2004

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

pain reduction [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00580151 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

anxiety reduction [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment

Condition ^ICMJE

Pain
Anxiety

Intervention ^ICMJE

Drug: clonidine
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2010

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

4 Years to 20 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Walter J. Meyer III, MD

(409) 747-8355

wmeyer@utmb.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00580151

Responsible Party

Walter J. Meyer III, M.D., University of Texas Medical Branch

Study ID Numbers ^ICMJE

04-101, IFF 489030

Study Sponsor ^ICMJE

The University of Texas, Galveston

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Walter J. Meyer III, MD

The University of Texas Medical Branch at Galveston

Information Provided By

The University of Texas, Galveston

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP