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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000135 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxymetazoline 0.05% | Experimental | Oxymetazoline 0.05% |
|
| Phenylephrine 0.25% | Experimental | Phenylephrine 0.25% |
|
| Lidocaine 1% plus epinephrine 1:100,000 | Experimental | Lidocaine 1% plus epinephrine 1:100,000 |
|
| Bacteriostatic 0.9% sodium chloride (NaCL) | Placebo Comparator | Bacteriostatic 0.9% NaCL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxymetazoline 0.05% | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Arterial Blood Pressure | Change in mean arterial blood pressure from the baseline measurement | baseline, 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure | Change from baseline in systolic blood pressure. | baseline, 30 minutes |
| Change in Diastolic Blood Pressure | Change from baseline in diastolic blood pressure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Kummer, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30195946 | Background | 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. |
| Label | URL |
|---|---|
| The Journal of Emergency Medicine | View source |
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None to report
Healthy volunteers over the age of eighteen that have been recently dismissed from the Emergency Department at Mayo Clinic Hospital, Saint Marys Campus beginning 11-12-14.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxymetazoline 0.05% | Oxymetazoline 0.05% 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. |
| FG001 | Phenylephrine 0.25% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Phenylephrine 0.25% | 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 | 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% NaCL | 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. |
|
| baseline, 30 minutes |
| Change in Heart Rate | Change from baseline in heart rate. | baseline, 30 minutes |
Phenylephrine 0.25% 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. |
| FG002 | Lidocaine 1% Plus Epinephrine 1:100,000 | Lidocaine 1% plus epinephrine 1:100,000 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. |
| FG003 | Bacteriostatic 0.9% Sodium Chloride (NaCL) | Bacteriostatic 0.9% NaCL Bacteriostatic 0.9% sodium chloride (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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxymetazoline 0.05% | Oxymetazoline 0.05% 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. |
| BG001 | Phenylephrine 0.25% | Phenylephrine 0.25% 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. |
| BG002 | Lidocaine 1% Plus Epinephrine 1:100,000 | Lidocaine 1% plus epinephrine 1:100,000 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. |
| BG003 | Bacteriostatic 0.9% NaCL | Bacteriostatic 0.9% sodium chloride (NaCL) Bacteriostatic 0.9% sodium chloride (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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Arterial Blood Pressure | Change in mean arterial blood pressure from the baseline measurement | Posted | Mean | Standard Deviation | mmHg | baseline, 30 minutes |
|
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| Secondary | Change in Systolic Blood Pressure | Change from baseline in systolic blood pressure. | Posted | Mean | Standard Deviation | mmHg | baseline, 30 minutes |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Diastolic Blood Pressure | Change from baseline in diastolic blood pressure. | Posted | Mean | Standard Deviation | mmHg | baseline, 30 minutes |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Heart Rate | Change from baseline in heart rate. | Posted | Mean | Standard Deviation | beats/min | baseline, 30 minutes |
|
Adverse events were collected for the duration of the study protocol. Total observation time was 30 minutes and after completion of the study protocol any adverse effects were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxymetazoline 0.05% | Oxymetazoline 0.05% 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. | 0 | 15 | 0 | 15 | 4 | 15 |
| EG001 | Phenylephrine 0.25% | Phenylephrine 0.25% 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. | 0 | 20 | 0 | 20 | 3 | 20 |
| EG002 | Lidocaine 1% Plus Epinephrine 1:100,000 | Lidocaine 1% plus epinephrine 1:100,000 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. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Bacteriostatic 0.9% NaCL | Bacteriostatic 0.9% sodium chloride (NaCL) Bacteriostatic 0.9% sodium chloride (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. | 0 | 17 | 0 | 17 | 2 | 17 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Pain | General disorders | Systematic Assessment |
| ||
| Eye watering | Eye disorders | Systematic Assessment |
| ||
| Diziness | General disorders | Systematic Assessment |
| ||
| Unpleasant aftertaste | General disorders | Systematic Assessment |
|
The primary limitation was the small sample size as enrollment was markedly more difficult than anticipated.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tobias Kummer | Mayo Clinic | 507 255 4732 | vanmeter.derek@mayo.edu |
| ID | Term |
|---|---|
| D004844 | Epistaxis |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Superiority |
| Fisher Exact | 0.93 | Superiority |
Bacteriostatic 0.9% sodium chloride (NaCL)
Bacteriostatic 0.9% NaCL: sterile gauze soaked in 5 milliliters (mL) of Bacteriostatic 0.9% sodium chloride (NaCL) 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% sodium chloride (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.
|
|
|
Bacteriostatic 0.9% sodium chloride (NaCL)
Bacteriostatic 0.9% sodium chloride (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.
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