Post Burn Pruritus Study in Patients Undergoing Wound Healing

Sponsor

United States Army Institute of Surgical Research (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00137202

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Itching	Drug: Ondansetron (Zofran) Drug: Diphenhydramine (Benadryl)	N/A

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

Study Type:

Interventional

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 :

Jun 1, 2005

Actual Primary Completion Date :

May 1, 2006

Actual Study Completion Date :

May 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2	Drug: Ondansetron (Zofran) Drug: Diphenhydramine (Benadryl)

Arm

Intervention/Treatment

Active Comparator: 2

Drug: Ondansetron (Zofran)

Drug: Diphenhydramine (Benadryl)

Outcome Measures

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. [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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