24 Participants Needed

Phenylephrine for Blood Loss in Burn Surgery

JG
Overseen ByJustin Gawaziuk, MSc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

The tumescent technique, which involves the use of epinephrine (a drug similar to phenylephrine), has been shown to decrease blood loss during burn surgery, suggesting that phenylephrine might also be effective in this context.12345

Is phenylephrine generally safe for use in humans?

Phenylephrine is considered one of the safer nonprescription medications for people with high blood pressure, but it can cause serious bradycardia (very slow heart rate) in some cases, especially when used during spinal anesthesia for cesarean sections.12678

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

I need surgery for a burn covering 5-30% of my body.

Exclusion Criteria

I am currently taking a Beta-blocker medication.
I have a history of high blood pressure.
I have a history of heart or blood vessel disease.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either phenylephrine or epinephrine solution during surgery to control blood loss

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood pressure and heart rate measurements

4 weeks

Treatment Details

Interventions

  • Phenylephrine
Trial Overview The study tests if phenylephrine can control blood loss during skin grafting without affecting heart rate and blood pressure like epinephrine does. Patients will receive a phenylephrine solution injection at the injury site before grafting to see if it's more effective and safer than the standard epinephrine solution.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: PhenylephrineExperimental Treatment1 Intervention
20 ug/cc
Group II: EpinephrineActive Control1 Intervention
1:1000000

Phenylephrine is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Neo-Synephrine for:
  • Nasal congestion
  • Hypotension
  • Burn injury management
🇪🇺
Approved in European Union as Phenylephrine for:
  • Nasal congestion
  • Hypotension
  • Burn injury management
🇨🇦
Approved in Canada as Sudafed PE for:
  • Nasal congestion
  • Hypotension

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials
628
Recruited
209,000+

Findings from Research

A study involving 270 burn patients from two centers showed that the timing of burn excision surgery for patients with amphetamine positivity is safe, regardless of whether a negative toxicology result is obtained before surgery.
The need for vasoactive support during surgery was not influenced by the toxicology results, indicating that waiting for a negative test is unnecessary and that the severity of burns (specifically >20% body surface area burned) is a more critical factor in intraoperative management.
Amphetamine Positivity Prior to Burn Surgery Does not Adversely Affect Intraoperative Outcomes.Rizk, N., Crawford, D., Karanas, Y., et al.[2023]
The 'HYPOTENS' study is a national, multi-center trial comparing the effectiveness of cafedrine/theodrenaline versus ephedrine in treating intra-operative hypotension in patients aged 50 and older, as well as those undergoing Cesarean sections, ensuring real-world clinical practice conditions.
The primary goal is to evaluate how well each treatment restores blood pressure and affects post-operative outcomes, such as heart rate and delirium, with results expected to provide insights into the best management strategies for hypotensive patients.
A non-interventional comparative study of the 20:1 combination of cafedrine/theodrenaline versus ephedrine for the treatment of intra-operative arterial hypotension: the 'HYPOTENS' study design and rationale.Eberhart, L., Geldner, G., Huljic, S., et al.[2019]
An 81-year-old patient with severe burns covering 51% of their body was successfully treated with Suprathel(®), which is known for its pain-free application and reduced need for analgesics and sedatives.
The use of Suprathel(®) likely contributed to the patient's favorable recovery, as it minimized pain and the need for additional medications that could destabilize cardiovascular health, leading to a discharge without significant handicaps after 69 days.
Suprathel(®) for severe burns in the elderly: Case report and review of the literature.Fischer, S., Kremer, T., Horter, J., et al.[2017]

References

Amphetamine Positivity Prior to Burn Surgery Does not Adversely Affect Intraoperative Outcomes. [2023]
A non-interventional comparative study of the 20:1 combination of cafedrine/theodrenaline versus ephedrine for the treatment of intra-operative arterial hypotension: the 'HYPOTENS' study design and rationale. [2019]
Suprathel(®) for severe burns in the elderly: Case report and review of the literature. [2017]
Comparison of hypotensive properties of dexmedetomidine versus clonidine for induced hypotension during functional endoscopic sinus surgery: A randomised, double-blind interventional study. [2022]
The tumescent technique to significantly reduce blood loss during burn surgery. [2019]
Safety of Phenylephrine in Antihypotensive Treatment during Spinal Anesthesia for Cesarean Section. [2018]
Subcutaneous adrenaline infiltration in paediatric burn surgery. [2013]
Nonprescription drugs and hypertension. Which ones affect blood pressure? [2019]
Effect of topical and subcutaneous epinephrine in combination with topical thrombin in blood loss during immediate near-total burn wound excision in pediatric burned patients. [2019]
Administration of Tumescence in Pediatric Burn Patients Causes Significant Hypertension. [2020]
QA project: Hemodynamic safety of endobronchial administration of phenylephrine for control of airway bleeding by bronchoscopy. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security