Post Burn Pruritus Study in Patients Undergoing Wound Healing

Not Applicable

Completed

• Conditions: Itching
• Interventions: Drug: Ondansetron (Zofran); Drug: Diphenhydramine (Benadryl)

• Registration Number: NCT00137202
• Lead Sponsor: United States Army Institute of Surgical Research

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 Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-29
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-24
• Last Update Posted: 2008-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Ondansetron (Zofran)	-
2	Diphenhydramine (Benadryl)	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

US Army Institute of Surgical Research; 🇺🇸 Fort Sam Houston, Texas, United States