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Post Burn Pruritus Study in Patients Undergoing Wound Healing

Information source: United States Army Institute of Surgical Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Itching

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

Phase: N/A

Status: Completed

Sponsored by: United States Army Institute of Surgical Research

Official(s) and/or principal investigator(s):
Stuart Gross, MD, Principal Investigator, Affiliation: Wilford Hall Medical Center, Lackland AFB, San Antonio, TX
Steven E Wolf, MD, Study Director, Affiliation: US Army Institute of Surgical Research, Fort Sam Houston, TX


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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

US Army Institute of Surgical Research, Fort Sam Houston, Texas 78234, United States
Additional Information

Related 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.

Starting date: June 2005
Last updated: July 24, 2008

Page last updated: August 23, 2015

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