Post Burn Pruritus Study in Patients Undergoing Wound Healing - Full Text View

Sponsor:	United States Army Institute of Surgical Research
Information provided by:	United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:	NCT00137202

Purpose

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	Intervention
Itching	Drug: Ondansetron (Zofran) Drug: Diphenhydramine (Benadryl)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Crossover Assignment, Bio-equivalence Study
Official Title:	A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing

Resource links provided by NLM:

MedlinePlus related topics: Burns Itching

Drug Information available for: Promethazine hydrochloride Diphenhydramine Promethazine Diphenhydramine citrate Ondansetron hydrochloride Ondansetron Diphenhydramine hydrochloride

U.S. FDA Resources

Further study details as provided by United States Army Institute of Surgical Research:

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. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	June 2005
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator	Drug: Ondansetron (Zofran) Drug: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137202

Locations

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

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

Publications:

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.

Responsible Party:	USAISR
Study ID Numbers:	H-04-006
Study First Received:	August 25, 2005
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00137202 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:

pruritus
burn wound

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Anesthetics
Serotonin Antagonists
Promethazine
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Antipruritics
Ondansetron
Dermatologic Agents
Tranquilizing Agents

Gastrointestinal Agents
Histamine Agents
Central Nervous System Depressants
Anti-Allergic Agents
Antipsychotic Agents
Pharmacologic Actions
Anesthetics, Local
Serotonin Agents
Histamine Antagonists
Autonomic Agents
Histamine H1 Antagonists
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Diphenhydramine

ClinicalTrials.gov processed this record on November 25, 2009