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

• ClinicalTrials.gov Identifier: NCT02285634
• Recruitment Status: Completed
• First Posted: November 7, 2014
• Results First Posted: October 2, 2018
• Last Update Posted: October 2, 2018
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Tobias Kummer, Mayo Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Epistaxis; Blood Pressure	Drug: Oxymetazoline 0.05%; Drug: Phenylephrine 0.25%; Drug: Lidocaine 1% plus epinephrine 1:100,000; Drug: Bacteriostatic 0.9% NaCL	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.
• Actual Study Start Date: November 2014
• Actual Primary Completion Date: December 22, 2016
• Actual Study Completion Date: December 22, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Oxymetazoline 0.05%; Oxymetazoline 0.05%	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.
Experimental: Phenylephrine 0.25%; Phenylephrine 0.25%	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.
Experimental: Lidocaine 1% plus epinephrine 1:100,000; Lidocaine 1% plus epinephrine 1:100,000	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.
Placebo Comparator: Bacteriostatic 0.9% sodium chloride (NaCL); Bacteriostatic 0.9% NaCL	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.

Outcome Measures

Primary Outcome Measures :

1. Change in Mean Arterial Blood Pressure [ Time Frame: baseline, 30 minutes ]
   Change in mean arterial blood pressure from the baseline measurement

Secondary Outcome Measures :

1. Change in Systolic Blood Pressure [ Time Frame: baseline, 30 minutes ]
   Change from baseline in systolic blood pressure.
2. Change in Diastolic Blood Pressure [ Time Frame: baseline, 30 minutes ]
   Change from baseline in diastolic blood pressure.
3. Change in Heart Rate [ Time Frame: baseline, 30 minutes ]
   Change from baseline in heart rate.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Tobias Kummer, MD; Mayo Clinic

More Information

Additional Information:

The Journal of Emergency Medicine 

Publications:

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.

• Responsible Party: Tobias Kummer, Assistant Professor of Emergency Medicine, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02285634
• Other Study ID Numbers: 14-006312; UL1TR000135 ( U.S. NIH Grant/Contract )
• First Posted: November 7, 2014
• Results First Posted: October 2, 2018
• Last Update Posted: October 2, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Epistaxis; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Signs and Symptoms, Respiratory; Lidocaine; Phenylephrine; Epinephrine; Oxymetazoline; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Adrenergic beta-Agonists; Bronchodilator Agents; Autonomic Agents; Anti-Asthmatic Agents