Post Burn Pruritus Study in Patients Undergoing Wound Healing - Tabular View

Tracking Information

First Received Date ^ICMJE

August 25, 2005

Last Updated Date

July 24, 2008

Start Date ^ICMJE

June 2005

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00137202 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Post Burn Pruritus Study in Patients Undergoing Wound Healing

Official Title ^ICMJE

A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Crossover Assignment, Bio-equivalence Study

Condition ^ICMJE

Itching

Intervention ^ICMJE

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

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2006

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00137202

Responsible Party

USAISR

Study ID Numbers ^ICMJE

H-04-006

Study Sponsor ^ICMJE

United States Army Institute of Surgical Research

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

United States Army Institute of Surgical Research

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP