Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by University of Manitoba
Information provided by (Responsible Party):
University of Manitoba Identifier:
First received: November 15, 2012
Last updated: November 30, 2015
Last verified: November 2015

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 Intervention Phase
Blood Loss, Surgical
Drug: Phenylephrine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury - A Randomized Control Trial

Resource links provided by NLM:

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Mean arterial blood pressure (MAP) [ Time Frame: during first 30 minutes ] [ Designated as safety issue: Yes ]
    Mean arterial blood pressure

Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: q15 min ] [ Designated as safety issue: Yes ]

    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

  • Heart Rate [ Time Frame: q15 min ] [ Designated as safety issue: Yes ]


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

Estimated Enrollment: 24
Study Start Date: December 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phenylephrine
20 ug/cc
Drug: Phenylephrine
Active Comparator: Epinephrine
Drug: Phenylephrine


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01731444

Contact: Justin Gawaziuk, MSc 2047873669

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

Responsible Party: University of Manitoba Identifier: NCT01731444     History of Changes
Other Study ID Numbers: PhenylephrineRCT 
Study First Received: November 15, 2012
Last Updated: November 30, 2015
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
blood loss

Additional relevant MeSH terms:
Blood Loss, Surgical
Intraoperative Complications
Pathologic Processes
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Autonomic Agents
Cardiotonic Agents
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Vasoconstrictor Agents processed this record on May 26, 2016