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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether phenylephrine, a medication used to increase blood pressure, can reduce blood loss during burn surgery without affecting heart rate or blood pressure. Traditionally, epinephrine is used, but it can alter these vital signs. Participants will receive injections of either phenylephrine or epinephrine to determine which is more effective and safer. The trial seeks individuals with burns requiring skin grafts, covering 5-30% of their body, excluding areas like the head, hands, or feet. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that phenylephrine, the treatment tested in this study, is generally safe for people. Phenylephrine primarily targets specific areas in the body, minimizing side effects related to heart rate and blood pressure.

Previous studies have found that phenylephrine can reduce blood loss during surgeries. For example, phenylephrine nasal drops have successfully reduced bleeding in children's surgeries. In other procedures, such as cesarean deliveries, phenylephrine has been well-tolerated and has helped maintain stable blood pressure.

This trial is in an early phase, focusing on safety and dosage. However, existing evidence from other uses of phenylephrine suggests it is likely to be well-tolerated. These findings may reassure those considering participation about the safety of phenylephrine.12345

Why do researchers think this study treatment might be promising?

Most treatments for blood loss during burn surgery, like epinephrine, act by constricting blood vessels, which helps to reduce bleeding. However, phenylephrine offers a unique approach. Unlike other treatments, phenylephrine specifically targets alpha-1 adrenergic receptors, which may provide a more controlled way to manage blood loss without affecting heart rate significantly. Researchers are excited about phenylephrine because it could offer a more precise and potentially safer option for patients undergoing such surgeries.

What evidence suggests that phenylephrine might be an effective treatment for reducing blood loss in burn surgery?

Research has shown that phenylephrine, which participants in this trial may receive, helps maintain steady blood pressure during certain medical procedures. It effectively prevents low blood pressure without significantly affecting heart rate. This makes it a promising option for reducing blood loss in surgeries, such as those for burn injuries, without the heart-related side effects associated with epinephrine, another treatment option in this trial. Phenylephrine primarily works by narrowing blood vessels, aiding in bleeding control. Overall, evidence supports its potential to manage blood loss while keeping heart rate and blood pressure stable.678910

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: PhenylephrineExperimental Treatment1 Intervention
Group II: EpinephrineActive Control1 Intervention

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

🇺🇸
Approved in United States as Neo-Synephrine for:
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Approved in European Union as Phenylephrine for:
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Approved in Canada as Sudafed PE for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials
628
Recruited
209,000+

Published Research Related to This Trial

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]
In a study of 258 pediatric burn patients undergoing various surgical procedures, there was a high incidence of hypertension (62.8%) associated with the use of tumescence containing phenylephrine during surgery.
The weight-adjusted volume of tumescence was identified as a significant predictor of intraoperative hypertension, with an odds ratio of 2.0, indicating that careful consideration is needed when using this practice in pediatric burn operations.
Administration of Tumescence in Pediatric Burn Patients Causes Significant Hypertension.Weis, HB., Meinhardt, KE., Minhajuddin, A., et al.[2020]
In a study of 70 adult patients undergoing functional endoscopic sinus surgery, both dexmedetomidine and clonidine effectively achieved controlled hypotension and improved surgical field quality without significant adverse effects.
Dexmedetomidine was found to provide better haemodynamic stability and longer post-operative analgesia compared to clonidine, making it a potentially superior choice for managing blood pressure during surgery.
Comparison of hypotensive properties of dexmedetomidine versus clonidine for induced hypotension during functional endoscopic sinus surgery: A randomised, double-blind interventional study.Bafna, U., Sharma, P., Singhal, RK., et al.[2022]

Citations

Effects of continuous infusion of phenylephrine vs ...In this dataset, continuous phenylephrine infusion reduced the incidence of SA-induced hypotension, ameliorated SVR, while decreasing overall maternal ...
Record History | ver. 2: 2021-08-31 | NCT04195321PE had been the preferred vasopressor for prophylaxis against post-spinal hypotension especially in obstetric population. it was reported that PE improved the ...
(PDF) Efficacy and safety of norepinephrine versus ...Conclusions: Both NE and PE infusions effectively prevented spinal anesthesia-induced hypotension in elderly patients undergoing hip fracture surgery. However, ...
Norepinephrine versus phenylephrine for treating ...We broadly hypothesise that use of NE infusions instead of PE infusions will improve blood flow to vital organs during the perioperative period ...
A Comparison of Phenylephrine and Norepinephrine ...This study compares the efficacy and safety of prophylactic intravenous infusions of norepinephrine and phenylephrine, administered at varying ...
Phenylephrine - StatPearls - NCBI Bookshelf - NIHPhenylephrine primarily acts as an alpha-1 adrenergic receptor agonist and exhibits minimal to no beta-adrenergic activity.
Phenylephrine for Blood Loss in Burn SurgeryNo complications or side effects were reported from using epinephrine, suggesting it is safe; however, the findings indicate that its routine use during ...
Phenylephrine Tumescence for Hemostasis in Surgery ...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.
The Effect of Phenylephrine Nasal Drops on Surgical ...It seems that the use of nasal phenylephrine drops in pediatric cleft palate surgeries can significantly reduce bleeding and increase the quality of the ...
Effect of Prophylactic Phenylephrine Infusion Versus ...Conclusions: Prophylactic phenylephrine infusion provides superior maternal hemodynamic stability and better tolerance during cesarean delivery compared to ...
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