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Post Burn Pruritus Study in Patients Undergoing Wound Healing

This study has been completed.
Sponsor:
Information provided by:
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00137202
First received: August 25, 2005
Last updated: July 24, 2008
Last verified: July 2008
History of Changes
  Purpose

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).


Condition Intervention
Itching
 Drug: Ondansetron (Zofran)
Drug: Diphenhydramine (Benadryl)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing

Resource links provided by NLM:

MedlinePlus related topics: Burns Itching
U.S. FDA Resources

Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: June 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 Drug: Ondansetron (Zofran) Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137202

Locations
United States, Texas
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
Investigators
Principal Investigator: Stuart Gross, MD Wilford Hall Medical Center, Lackland AFB, San Antonio, TX
Study Director: Steven E Wolf, MD US Army Institute of Surgical Research, Fort Sam Houston, TX
  More Information

Publications:

Responsible Party: USAISR
ClinicalTrials.gov Identifier: NCT00137202     History of Changes
Other Study ID Numbers: H-04-006
Study First Received: August 25, 2005
Last Updated: July 24, 2008
Health Authority: United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:
pruritus
burn wound

Additional relevant MeSH terms:
Diphenhydramine
Ondansetron
Promethazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on May 23, 2013