Status:
COMPLETED
Post Burn Pruritus Study in Patients Undergoing Wound Healing
Lead Sponsor:
United States Army Institute of Surgical Research
Conditions:
Itching
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to see if a drug called ondansetron (Zofran) controls itching from healing burn wounds as well or better than the usual drug used, diphenhydramine (Benadryl).
Detailed Description
A clear mechanism or cause for pruritus in patients recovering from burn has not been delineated. While the exact mechanisms/pathways for itching are currently unclear, histamine antagonism appears t...
Eligibility Criteria
Inclusion
- Males or females; 18 years or older.
- Seen in the United States Army Institute of Surgical Research (USAISR) Burn Clinic with healing burn wounds of any percent (%) of total body surface area (TBSA) causing pruritus
- Stable medical condition
- Negative pregnancy test and not nursing
- Able to indicate status of pruritus on a numeric scale
- Able to understand and read English
Exclusion
- Unstable medical condition as determined by attending burn surgeon
- Prisoner
- History of allergic reaction to serotonin inhibitors or diphenhydramine
- Pregnant or lactating
- Unable to verbalize pruritus intensity scale
- Unable to understand or read English
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00137202
Start Date
June 1 2005
End Date
May 1 2006
Last Update
July 28 2008
Active Locations (1)
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1
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234