Itching
Conditions
Keywords
pruritus, burn wound
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.
Interventions
Sponsors
United States Army Institute of Surgical Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed