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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285634
• Other study ID #: 14-006312
• Secondary ID: UL1TR000135
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 22, 2017

Study information

• Verified date: September 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 22, 2017
• Est. primary completion date: December 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Epistaxis

Intervention

Drug:
• Oxymetazoline 0.05%
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.
• Phenylephrine 0.25%
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.
• Lidocaine 1% plus epinephrine 1:100,000
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.
• Bacteriostatic 0.9% NaCL
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bellew, Shawna D, Johnson, Katie L, Nichols, Micah D., Kummer, Tobias. Effect of Intranasal Vasoconstrictors on Blood Pressure: A Randomized, Double-Blind, Placebo-Controlled Trial. In Press, Corrected Proof, Available online 6 September 2018

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Arterial Blood Pressure	Change in mean arterial blood pressure from the baseline measurement	baseline, 30 minutes
Secondary	Change in Systolic Blood Pressure	Change from baseline in systolic blood pressure.	baseline, 30 minutes
Secondary	Change in Diastolic Blood Pressure	Change from baseline in diastolic blood pressure.	baseline, 30 minutes
Secondary	Change in Heart Rate	Change from baseline in heart rate.	baseline, 30 minutes

External Links

•   The Journal of Emergency Medicine