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

Not Applicable

Completed

Conditions: Blood Pressure
Epistaxis

Interventions: Drug: Bacteriostatic 0.9% NaCL
Drug: Oxymetazoline 0.05%
Drug: Phenylephrine 0.25%

Registration Number: NCT02285634

Lead Sponsor: Mayo Clinic

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 68

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bacteriostatic 0.9% sodium chloride (NaCL)	Bacteriostatic 0.9% NaCL	Bacteriostatic 0.9% NaCL
Oxymetazoline 0.05%	Oxymetazoline 0.05%	Oxymetazoline 0.05%
Phenylephrine 0.25%	Phenylephrine 0.25%	Phenylephrine 0.25%

Primary Outcome Measures

Name	Time	Method
Change in Mean Arterial Blood Pressure	baseline, 30 minutes	Change in mean arterial blood pressure from the baseline measurement

Secondary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure	baseline, 30 minutes	Change from baseline in systolic blood pressure.
Change in Diastolic Blood Pressure	baseline, 30 minutes	Change from baseline in diastolic blood pressure.
Change in Heart Rate	baseline, 30 minutes	Change from baseline in heart rate.