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

Primary Purpose

Epistaxis, Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxymetazoline 0.05%
Phenylephrine 0.25%
Lidocaine 1% plus epinephrine 1:100,000
Bacteriostatic 0.9% NaCL
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epistaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Oxymetazoline 0.05%

Phenylephrine 0.25%

Lidocaine 1% plus epinephrine 1:100,000

Bacteriostatic 0.9% sodium chloride (NaCL)

Arm Description

Oxymetazoline 0.05%

Phenylephrine 0.25%

Lidocaine 1% plus epinephrine 1:100,000

Bacteriostatic 0.9% NaCL

Outcomes

Primary Outcome Measures

Change in Mean Arterial Blood Pressure
Change in mean arterial blood pressure from the baseline measurement

Secondary Outcome Measures

Change in Systolic Blood Pressure
Change from baseline in systolic blood pressure.
Change in Diastolic Blood Pressure
Change from baseline in diastolic blood pressure.
Change in Heart Rate
Change from baseline in heart rate.

Full Information

First Posted
November 5, 2014
Last Updated
September 7, 2018
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02285634
Brief Title
The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.
Official Title
The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
December 22, 2016 (Actual)
Study Completion Date
December 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis, Blood Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxymetazoline 0.05%
Arm Type
Experimental
Arm Description
Oxymetazoline 0.05%
Arm Title
Phenylephrine 0.25%
Arm Type
Experimental
Arm Description
Phenylephrine 0.25%
Arm Title
Lidocaine 1% plus epinephrine 1:100,000
Arm Type
Experimental
Arm Description
Lidocaine 1% plus epinephrine 1:100,000
Arm Title
Bacteriostatic 0.9% sodium chloride (NaCL)
Arm Type
Placebo Comparator
Arm Description
Bacteriostatic 0.9% NaCL
Intervention Type
Drug
Intervention Name(s)
Oxymetazoline 0.05%
Intervention Description
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
Intervention Name(s)
Phenylephrine 0.25%
Intervention Description
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
Intervention Name(s)
Lidocaine 1% plus epinephrine 1:100,000
Intervention Description
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
Intervention Name(s)
Bacteriostatic 0.9% NaCL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Mean Arterial Blood Pressure
Description
Change in mean arterial blood pressure from the baseline measurement
Time Frame
baseline, 30 minutes
Secondary Outcome Measure Information:
Title
Change in Systolic Blood Pressure
Description
Change from baseline in systolic blood pressure.
Time Frame
baseline, 30 minutes
Title
Change in Diastolic Blood Pressure
Description
Change from baseline in diastolic blood pressure.
Time Frame
baseline, 30 minutes
Title
Change in Heart Rate
Description
Change from baseline in heart rate.
Time Frame
baseline, 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Kummer, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30195946
Citation
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.
Results Reference
background
Links:
URL
https://doi.org/10.1016/j.jemermed.2018.07.004
Description
The Journal of Emergency Medicine

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

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