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Post Burn Pruritus Study in Patients Undergoing Wound Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00137202
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : July 28, 2008
Sponsor:
Information provided by:
United States Army Institute of Surgical Research

Study Description
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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).

Condition or disease Intervention/treatment Phase
Itching Drug: Ondansetron (Zofran) Drug: Diphenhydramine (Benadryl) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing
Study Start Date : June 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 2 Drug: Ondansetron (Zofran)
Drug: Diphenhydramine (Benadryl)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137202


Locations
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United States, Texas
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
Investigators
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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
More Information
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Publications:

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Responsible Party: USAISR
ClinicalTrials.gov Identifier: NCT00137202    
Other Study ID Numbers: H-04-006
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: July 28, 2008
Last Verified: July 2008
Keywords provided by United States Army Institute of Surgical Research:
pruritus
burn wound
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations
Diphenhydramine
Promethazine
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Anesthetics, Local
Anesthetics
Sensory System Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents