Clinical trial NCT02285634: The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.
Official title: The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epistaxis
Blood Pressure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Mean Arterial Blood Pressure
timeFrame: baseline, 30 minutes
Secondary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: baseline, 30 minutes
measure: Change in Diastolic Blood Pressure
timeFrame: baseline, 30 minutes
measure: Change in Heart Rate
timeFrame: baseline, 30 minutes
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Tobias Kummer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bellew SD, Johnson KL, Nichols MD, Kummer T. Effect of Intranasal Vasoconstrictors on Blood Pressure: A Randomized, Double-Blind, Placebo-Controlled Trial. J Emerg Med. 2018 Oct;55(4):455-464. doi: 10.1016/j.jemermed.2018.07.004. Epub 2018 Sep 6.