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Post Burn Pruritus Study in Patients Undergoing Wound Healing

U

United States Army Institute of Surgical Research

Status

Completed

Conditions

Itching

Treatments

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

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00137202
H-04-006

Details and patient eligibility

About

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).

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

36 participants in 1 patient group

2
Active Comparator group
Treatment:
Drug: Diphenhydramine (Benadryl)
Drug: Ondansetron (Zofran)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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