NCT02285634

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epistaxis
• Blood Pressure

Interventions

Type	Name	Description
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.
DRUG	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.
DRUG	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.
DRUG	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.

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-12-22
• Completion: 2017-12-22
• First posted: 2014-11-07
• Last updated: 2018-10-02
• Results posted: 2018-10-02

Locations

1 site across 1 country: United States