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CompletedNCT00137202Updated Jul 28, 2008

Post Burn Pruritus Study in Patients Undergoing Wound Healing

An interventional study of Ondansetron (Zofran) and Diphenhydramine (Benadryl) in Itching, sponsored by United States Army Institute of Surgical Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-07-28.

Sponsored by United States Army Institute of Surgical Research · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Itching

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Keywords

  • pruritus
  • burn wound
03

In context

Pruritus

354 studies on the registry are indexed under Pruritus; 74 are open to participants now.

This study's enrollment of 36 is below the median of 60 across 294 interventional studies indexed under Pruritus.

Browse Pruritus studies →

Lead sponsor

United States Army Institute of Surgical Research is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    2

    Drug: Ondansetron (Zofran) · Drug: Diphenhydramine (Benadryl)

Interventions

  • DrugOndansetron (Zofran)
  • DrugDiphenhydramine (Benadryl)
06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • US Army Institute of Surgical Research
    Fort Sam Houston, Texas 78234, United States
08

References and documents

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. doi: 10.1097/00004630-200101000-00017. PubMed 11227690 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00137202
Lead sponsor
United States Army Institute of Surgical Research
First posted
Aug 29, 2005
Start date
Jun 2005
Primary completion
May 2006
Completion
May 2006
Last update
Jul 28, 2008

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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