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

NCT ID: NCT02285634

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-12-22

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.

Conditions

Epistaxis; Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oxymetazoline 0.05%

Oxymetazoline 0.05%

Group Type: EXPERIMENTAL

Oxymetazoline 0.05%

Intervention Type: DRUG

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%

Phenylephrine 0.25%

Group Type: EXPERIMENTAL

Phenylephrine 0.25%

Intervention Type: DRUG

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

Lidocaine 1% plus epinephrine 1:100,000

Group Type: EXPERIMENTAL

Lidocaine 1% plus epinephrine 1:100,000

Intervention Type: DRUG

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% sodium chloride (NaCL)

Bacteriostatic 0.9% NaCL

Group Type: PLACEBO_COMPARATOR

Bacteriostatic 0.9% NaCL

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Tobias Kummer

Assistant Professor of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobias Kummer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30195946 (View on PubMed)

Related Links

https://doi.org/10.1016/j.jemermed.2018.07.004

The Journal of Emergency Medicine

Other Identifiers

UL1TR000135

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-006312

Identifier Type: -

Identifier Source: org_study_id