Phenylephrine for Blood Loss in Burn Surgery
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulants (except NSAIDs), monoamine oxidase inhibitors, tricyclic antidepressants, or beta-blockers.
What data supports the effectiveness of the drug Phenylephrine for reducing blood loss in burn surgery?
Is phenylephrine generally safe for use in humans?
How does the drug phenylephrine differ from other treatments for blood loss in burn surgery?
Phenylephrine is unique because it is an alpha-1 agonist that can be used to control blood loss by constricting blood vessels, which is different from other treatments like epinephrine that are more commonly used. It is also noted for its potential to cause hypertension (high blood pressure) when used in burn surgeries, which is a consideration not typically associated with other treatments.5691011
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for individuals with burn injuries needing skin grafts covering 5-30% of their body, excluding burns on the head, neck, hands, feet, and genitals. Participants should not have heart or vascular diseases, arrhythmias, hypertension; nor be taking anticoagulants (except NSAIDs), monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either phenylephrine or epinephrine solution during surgery to control blood loss
Follow-up
Participants are monitored for safety and effectiveness after treatment, including blood pressure and heart rate measurements
Treatment Details
Interventions
- Phenylephrine
Phenylephrine is already approved in United States, European Union, Canada for the following indications:
- Nasal congestion
- Hypotension
- Burn injury management
- Nasal congestion
- Hypotension
- Burn injury management
- Nasal congestion
- Hypotension
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Manitoba
Lead Sponsor