Post Burn Pruritus Study in Patients Undergoing Wound Healing
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing|
- 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 ]
|Study Start Date:||June 2005|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
|Active Comparator: 2||Drug: Ondansetron (Zofran) Drug: Diphenhydramine (Benadryl)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137202
|United States, Texas|
|US Army Institute of Surgical Research|
|Fort Sam Houston, Texas, United States, 78234|
|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|