Post Burn Pruritus Study in Patients Undergoing Wound Healing

Itching Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137202
• Other study ID #: H-04-006
• Status: Completed
• Phase: N/A
• First received: August 25, 2005
• Last updated: July 24, 2008
• Start date: June 2005
• Est. completion date: May 2006

Study information

• Verified date: July 2008
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Itching

Intervention

Drug:
• Ondansetron (Zofran)

• Diphenhydramine (Benadryl)

Locations

Country	Name	City	State
United States	US Army Institute of Surgical Research	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No