Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

Study Overview
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Brief Summary
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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.

Official Title
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Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury - A Randomized Control Trial

Conditions
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Blood Loss, Surgical

Intervention / Treatment
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* Drug: Phenylephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria a) Burn injury requiring debridement and grafting between 5-30% TBSA Exclusion Criteria Head and neck, hand, foot, or genital burns On anticoagulants (except NSAIDs) On monoamine oxidase inhibitor or tricyclic antidepressant Coronary or peripheral vascular disease History of arrhythmias On a Beta-blocker History of vascular abnormality Hypertension

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phenylephrine<br>20 ug/cc | Drug: Phenylephrine<br> <br> |
| Active Comparator: Epinephrine<br>1:1000000 | Drug: Phenylephrine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial blood pressure (MAP) | Mean arterial blood pressure | during first 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Cut off for safety: Diastolic >140 or Systolic >180; Recorded: just prior to induction of anesthesia maximum heart rate during time of procedure minimum heart rate during time of procedure | q15 min | 
| Heart Rate | Recorded: just prior to induction of anesthesia maximum heart rate during time of procedure minimum heart rate during time of procedure | q15 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood loss, burn, hemostasis