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Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01731444
Enrollment
24
Registered
2012-11-21
Start date
2014-12-01
Completion date
2028-12-31
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss, Surgical

Keywords

blood loss, burn, hemostasis

Brief summary

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.

Interventions

DRUGPhenylephrine

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Mean arterial blood pressure (MAP)during first 30 minutesMean arterial blood pressure

Secondary

MeasureTime frameDescription
Blood Pressureq15 minCut 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
Heart Rateq15 minRecorded: * just prior to induction of anesthesia * maximum heart rate during time of procedure * minimum heart rate during time of procedure

Countries

Canada

Contacts

CONTACTJustin Gawaziuk, MSc
jgawaziuk@hsc.mb.ca2047873669

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026