The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.

Study Overview
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Brief Summary
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Nosebleeds (epistaxis) are a frequent cause of emergency department visits, reportedly inciting 1 in 200 visits. They are most common in those less than ten and older than seventy, often occurring in the winter months secondary to dry indoor heating. Epistaxis is associated with elevated blood pressures, but it is controversial whether hypertension is actual a contributing cause. In non-life-threatening epistaxis, the first step in management is commonly the application of a topical vasoconstrictive medication. In many cases this will lead to cessation of the bleeding or facilitate the exam in those that continue to bleed. Frequently used medications include phenylephrine, oxymetazoline, and lidocaine with epinephrine. Classic teaching has been to avoid the use of these medications in patients with elevated blood pressures due to concerns of inducing hypertensive crisis. Strict avoidance of topical vasoconstrictors in this patient group with epistaxis severely limits the treatment options for a many patients given the association between the two conditions. Though universally taught, the actual effect of these agents on blood pressure remains unquantified. Studies investigating the prevention of nose bleeding during nasotracheal intubations suggest that the effect might be minor with little variation between agents. Clinical question: What is the effect of commonly used intranasal vasoconstrictors on blood pressure in volunteers without a history of hypertension.

Official Title
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The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.

Conditions
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Epistaxis, Blood Pressure

Intervention / Treatment
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* Drug: Oxymetazoline 0.05%
* Drug: Phenylephrine 0.25%
* Drug: Lidocaine 1% plus epinephrine 1:100,000
* Drug: Bacteriostatic 0.9% NaCL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers over the age of eighteen that have been recently dismissed from the Emergency Department at Mayo Clinic Hospital, Saint Marys Campus. We will recruit a convenience sample of 100 patients from the Emergency Department who have completed their Emergency Department evaluation and treatment and are being discharged to home with non-painful conditions. Exclusion Criteria: We will exclude persons under the age of eighteen Vulnerable populations (pregnant patients and prisoners) Those with an allergy to any of the study agents Those with acute pain Those using antihypertensive or antiarrhythmic agents Those with significant cardiopulmonary comorbidities (namely history of arrhythmia, coronary artery disease, hypertension, and heart failure) Those with concomitant use of Monoamine oxidase A (MAO) Inhibitors Those with a diagnosis of angle closure glaucoma or benign prostatic hyperplasia (BPH) Those with a history of cerebrovascular disease As well as those with a history of previous nasal surgery or known nasal anatomic abnormalities.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxymetazoline 0.05%<br>Oxymetazoline 0.05% | Drug: Oxymetazoline 0.05%<br>* sterile gauze soaked in 5 milliliters (mL) of Oxymetazoline 0.05% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes.<br>|
| Experimental: Phenylephrine 0.25%<br>Phenylephrine 0.25% | Drug: Phenylephrine 0.25%<br>* sterile gauze soaked in 5 milliliters (mL) of Phenylephrine 0.25% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes.<br>|
| Experimental: Lidocaine 1% plus epinephrine 1:100,000<br>Lidocaine 1% plus epinephrine 1:100,000 | Drug: Lidocaine 1% plus epinephrine 1:100,000<br>* sterile gauze soaked in 5 milliliters (mL) of Lidocaine 1% plus epinephrine 1:100,000 into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes.<br>|
| Placebo Comparator: Bacteriostatic 0.9% sodium chloride (NaCL)<br>Bacteriostatic 0.9% NaCL | Drug: Bacteriostatic 0.9% NaCL<br>* sterile gauze soaked in 5 milliliters (mL) of Bacteriostatic 0.9% NaCL into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Arterial Blood Pressure | Change in mean arterial blood pressure from the baseline measurement | baseline, 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure | Change from baseline in systolic blood pressure. | baseline, 30 minutes | 
| Change in Diastolic Blood Pressure | Change from baseline in diastolic blood pressure. | baseline, 30 minutes | 
| Change in Heart Rate | Change from baseline in heart rate. | baseline, 30 minutes |