- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00137202
Post Burn Pruritus Study in Patients Undergoing Wound Healing
A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Fort Sam Houston, Texas, United States, 78234
- US Army Institute of Surgical Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
14 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stuart Gross, MD, Wilford Hall Medical Center, Lackland AFB, San Antonio, TX
- Study Director: Steven E Wolf, MD, US Army Institute of Surgical Research, Fort Sam Houston, TX
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Manifestations
- Pruritus
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Hypnotics and Sedatives
- Anti-Anxiety Agents
- Anesthetics, Local
- Anti-Allergic Agents
- Sleep Aids, Pharmaceutical
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Diphenhydramine
- Promethazine
- Ondansetron
Other Study ID Numbers
- H-04-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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