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

This study is currently recruiting participants.
Verified August 2016 by Tobias Kummer, Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285634
First Posted: November 7, 2014
Last Update Posted: August 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tobias Kummer, Mayo Clinic
  Purpose

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 Intervention
Epistaxis Blood Pressure Drug: Oxymetazoline 0.05% Drug: Phenylephrine 0.25% Drug: Lidocaine 1% plus epinephrine 1:100,000 Drug: Bacteriostatic 0.9% NaCL

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Tobias Kummer, Mayo Clinic:

Primary Outcome Measures:
  • change mean arterial blood pressure [ Time Frame: 8 months ]
    Change in mean arterial blood pressure from the baseline measurement


Secondary Outcome Measures:
  • change systolic blood pressure [ Time Frame: 8 months ]
    Change from baseline in systolic blood pressure.

  • change diastolic blood pressure [ Time Frame: 8 months ]
    Change from baseline in diastolic blood pressure.

  • change heart rate [ Time Frame: 8 months ]
    Change from baseline in heart rate.


Estimated Enrollment: 100
Study Start Date: November 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxymetazoline 0.05%
Oxymetazoline 0.05%
Drug: Oxymetazoline 0.05%
sterile gauze soaked in 5mL 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 5mL 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 5mL 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% NaCL
Bacteriostatic 0.9% NaCL
Drug: Bacteriostatic 0.9% NaCL
sterile gauze soaked in 5mL 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 MAO-Inhibitors
  • Those with a diagnosis of angle closure glaucoma or 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285634


Contacts
Contact: Tobias Kummer, MD 507-255-4399 kummer.tobias@mayo.edu
Contact: Michael Ferrara, MS 507-293-1239 ferrara.michael@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michael J Ferrara, MS    507-293-1239    ferrara.michael@mayo.edu   
Contact: Derek Vanmeter    507-255-5056    vanmeter.derek@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Tobias Kummer, MD Mayo Clinic
  More Information

Responsible Party: Tobias Kummer, Assistant Professor of Emergency Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02285634     History of Changes
Other Study ID Numbers: 14-006312
First Submitted: November 5, 2014
First Posted: November 7, 2014
Last Update Posted: August 3, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Epistaxis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Phenylephrine
Oxymetazoline
Vasoconstrictor Agents
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