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Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

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ClinicalTrials.gov Identifier: NCT01731444
Recruitment Status : Recruiting
First Posted : November 21, 2012
Last Update Posted : November 15, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

The standard of care for treatment of burn injury is to inject a solution of epinephrine under the skin of the injured site in order to reduce blood loss during skin grafting. This solution of epinephrine has been shown to have effects on the body outside the donor site. Some people have increases in heart rate and blood pressure. We will study the effect of a phenylephrine solution in place of an epinephrine solution to control blood loss. We think that phenylephrine will help decrease blood loss and not change blood pressure or heart rate.

The injured area will be injected under the skin and a skin graft will be taken in the same way as we usually do. The only change will be the use of phenylephrine in the solution instead of epinephrine.

Our goal is to find whether or not phenylephrine or epinephrine solution results in a reduction of blood loss without affecting the rest of the body.

Condition or disease Intervention/treatment Phase
Blood Loss, Surgical Drug: Phenylephrine Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury - A Randomized Control Trial
Study Start Date : December 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Phenylephrine
20 ug/cc
Drug: Phenylephrine
Active Comparator: Epinephrine
Drug: Phenylephrine

Outcome Measures

Primary Outcome Measures :
  1. Mean arterial blood pressure (MAP) [ Time Frame: during first 30 minutes ]
    Mean arterial blood pressure

Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: q15 min ]

    Cut off for safety: Diastolic >140 or Systolic >180;


    • just prior to induction of anesthesia
    • maximum heart rate during time of procedure
    • minimum heart rate during time of procedure

  2. Heart Rate [ Time Frame: q15 min ]


    • just prior to induction of anesthesia
    • maximum heart rate during time of procedure
    • minimum heart rate during time of procedure

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

a) Burn injury requiring debridement and grafting between 5-30% TBSA

Exclusion Criteria

  1. Head and neck, hand, foot, or genital burns
  2. On anticoagulants (except NSAIDs)
  3. On monoamine oxidase inhibitor or tricyclic antidepressant
  4. Coronary or peripheral vascular disease
  5. History of arrhythmias
  6. On a Beta-blocker
  7. History of vascular abnormality
  8. Hypertension
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731444

Contact: Justin Gawaziuk, MSc 2047873669 jgawaziuk@hsc.mb.ca

Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Justin P Gawaziuk, MSc    2047873669    jgawaziuk@hsc.mb.ca   
Principal Investigator: Sarvesh Logsetty, MD         
Sponsors and Collaborators
University of Manitoba
More Information

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01731444     History of Changes
Other Study ID Numbers: PhenylephrineRCT
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016

Keywords provided by University of Manitoba:
blood loss

Additional relevant MeSH terms:
Blood Loss, Surgical
Pathologic Processes
Wounds and Injuries
Intraoperative Complications
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents