Post Burn Pruritus Study in Patients Undergoing Wound Healing
NCT ID: NCT00137202
Last Updated: 2008-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2005-06-30
2006-05-31
Brief Summary
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Detailed Description
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While the exact mechanisms/pathways for itching are currently unclear, histamine antagonism appears to be the most popular treatment. Whether histamine antagonism works predominantly via peripheral inhibition or central sedation is uncertain. By treating another intermediary in the pruritus cascade, it may be possible that an alternate treatment could be used while eliminating some of the unwanted side effects of antihistamine at the same time.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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2
Ondansetron (Zofran)
Diphenhydramine (Benadryl)
Interventions
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Ondansetron (Zofran)
Diphenhydramine (Benadryl)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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United States Army Institute of Surgical Research
FED
Responsible Party
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USAISR
Principal Investigators
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Stuart Gross, MD
Role: PRINCIPAL_INVESTIGATOR
Wilford Hall Medical Center, Lackland AFB, San Antonio, TX
Steven E Wolf, MD
Role: STUDY_DIRECTOR
US Army Institute of Surgical Research, Fort Sam Houston, TX
Locations
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US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States
Countries
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References
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Matheson JD, Clayton J, Muller MJ. The reduction of itch during burn wound healing. J Burn Care Rehabil. 2001 Jan-Feb;22(1):76-81; discussion 75. doi: 10.1097/00004630-200101000-00017.
Other Identifiers
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H-04-006
Identifier Type: -
Identifier Source: org_study_id