Not Signed In -
Ondansetron |
Zofran |
Clinical Trial: Post Burn Pruritus Study
This study is currently recruiting patients.
Verified by United States Army Institute of Surgical Research August 2005
|
Purpose
| Condition | Intervention |
|---|---|
| Itching | Drug: Ondansetron (Zofran) and Diphenhydramine (Benedryl) |
MedlinePlus related topics: Itching
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Bio-equivalence Study
Official Title: A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing
Expected Total Enrollment: 36
Study start: June 2005; Expected completion: July 2006
Last follow-up: July 2006; Data entry closure: July 2006
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 than an alternate treatment could be used while eliminating some of the unwanted side effects of antihistamine at the same time.
Eligibility
Inclusion Criteria:
- Male or female, 18 years or older
- Seen in the USAISR Burn Clinic with healing burn wounds of any % of 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
Location and Contact Information
Elizabeth Frail, RN, BSN 210-916-8192 elizabeth.frail@amedd.army.mil
Texas
US Army Institute of Surgical Research, Fort Sam Houston, Texas, 78234, United States; Recruiting
Nancy C Molter, RN, MSN, PhD 210-916-2834 nancy.molter@amedd.army.mil
Stuart Gross, MD, Principal Investigator
Stuart Gross, MD, Principal Investigator, Wilford Hall Medical Center, Lackland AFB, San Antonio, TX
Steven E Wolf, MD, Study Director, US Army Institute of Surgical Research, Fort Sam Houston, TX
More Information
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.
Last Updated: August 26, 2005
Record first received: August 25, 2005
ClinicalTrials.gov Identifier: NCT00137202
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-30
Resources
- Ondansetron (Drug Digest)
- Zofran (Drug Digest)
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