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Post Burn Pruritus Study in Patients Undergoing Wound Healing

Primary Purpose

Itching

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ondansetron (Zofran)
Diphenhydramine (Benadryl)
Sponsored by
United States Army Institute of Surgical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Itching focused on measuring pruritus, burn wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

  • US Army Institute of Surgical Research

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

2

Arm Description

Outcomes

Primary Outcome Measures

Ondansetron will have a greater ability to control pruritus in burn patients who are undergoing wound healing when compared to the standard of care, diphenhydramine.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2005
Last Updated
July 24, 2008
Sponsor
United States Army Institute of Surgical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00137202
Brief Title
Post Burn Pruritus Study in Patients Undergoing Wound Healing
Official Title
A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
United States Army Institute of Surgical Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Itching
Keywords
pruritus, burn wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ondansetron (Zofran)
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine (Benadryl)
Primary Outcome Measure Information:
Title
Ondansetron will have a greater ability to control pruritus in burn patients who are undergoing wound healing when compared to the standard of care, diphenhydramine.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Gross, MD
Organizational Affiliation
Wilford Hall Medical Center, Lackland AFB, San Antonio, TX
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven E Wolf, MD
Organizational Affiliation
US Army Institute of Surgical Research, Fort Sam Houston, TX
Official's Role
Study Director
Facility Information:
Facility Name
US Army Institute of Surgical Research
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11227690
Citation
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.
Results Reference
background

Learn more about this trial

Post Burn Pruritus Study in Patients Undergoing Wound Healing

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