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Completed

NCT Number: NCT00137202

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).

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Key information

Conditions

Itching Burns Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

US Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ondansetron (Zofran)

Drug

Diphenhydramine (Benadryl)

Drug

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

Sponsors and collaborators

Lead sponsor

United States Army Institute of Surgical Research

Fed

Registry information

Official study title

A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 29, 2005
Registry last updated
Jul 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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