Blood Pressure, Epistaxis
Conditions
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.
Interventions
DRUGOxymetazoline 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.
DRUGPhenylephrine 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.
DRUGLidocaine 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.
DRUGBacteriostatic 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Arterial Blood Pressure | baseline, 30 minutes | Change in mean arterial blood pressure from the baseline measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | baseline, 30 minutes | Change from baseline in systolic blood pressure. |
| Change in Diastolic Blood Pressure | baseline, 30 minutes | Change from baseline in diastolic blood pressure. |
| Change in Heart Rate | baseline, 30 minutes | Change from baseline in heart rate. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
None to report
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 20 |
| 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. | 11 |
| 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. | 17 |
| Total | 63 |
Baseline characteristics
| Characteristic | Phenylephrine 0.25% | Lidocaine 1% Plus Epinephrine 1:100,000 | Bacteriostatic 0.9% NaCL | Total | Oxymetazoline 0.05% |
|---|---|---|---|---|---|
| Age, Continuous | 40.0 years STANDARD_DEVIATION 16.8 | 38.6 years STANDARD_DEVIATION 15.7 | 31.2 years STANDARD_DEVIATION 10.1 | 36.0 years STANDARD_DEVIATION 14.4 | 34.5 years STANDARD_DEVIATION 15 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment United States | 20 participants | 11 participants | 17 participants | 63 participants | 15 participants |
| Sex: Female, Male Female | 8 Participants | 2 Participants | 8 Participants | 29 Participants | 11 Participants |
| Sex: Female, Male Male | 12 Participants | 9 Participants | 9 Participants | 34 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 20 | 0 / 11 | 0 / 17 |
| other Total, other adverse events | 4 / 15 | 3 / 20 | 0 / 11 | 2 / 17 |
| serious Total, serious adverse events | 0 / 15 | 0 / 20 | 0 / 11 | 0 / 17 |
Outcome results
Primary
Change in Mean Arterial Blood Pressure
Change in mean arterial blood pressure from the baseline measurement
Time frame: baseline, 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxymetazoline 0.05% | Change in Mean Arterial Blood Pressure | 5.1 mmHg | Standard Deviation 6.8 |
| Phenylephrine 0.25% | Change in Mean Arterial Blood Pressure | 6.4 mmHg | Standard Deviation 5.8 |
| Lidocaine 1% Plus Epinephrine 1:100,000 | Change in Mean Arterial Blood Pressure | 4.6 mmHg | Standard Deviation 8 |
| Bacteriostatic 0.9% NaCL | Change in Mean Arterial Blood Pressure | 6.5 mmHg | Standard Deviation 5.5 |
p-value: 0.42Fisher Exact
p-value: 0.52Fisher Exact
p-value: 0.93Fisher Exact
Secondary
Change in Diastolic Blood Pressure
Change from baseline in diastolic blood pressure.
Time frame: baseline, 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxymetazoline 0.05% | Change in Diastolic Blood Pressure | 5.7 mmHg | Standard Deviation 7.7 |
| Phenylephrine 0.25% | Change in Diastolic Blood Pressure | 7.9 mmHg | Standard Deviation 6.8 |
| Lidocaine 1% Plus Epinephrine 1:100,000 | Change in Diastolic Blood Pressure | 6.2 mmHg | Standard Deviation 8.3 |
| Bacteriostatic 0.9% NaCL | Change in Diastolic Blood Pressure | 9.3 mmHg | Standard Deviation 6.6 |
p-value: 0.27Fisher Exact
p-value: 0.17Fisher Exact
p-value: 0.56Fisher Exact
Secondary
Change in Heart Rate
Change from baseline in heart rate.
Time frame: baseline, 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxymetazoline 0.05% | Change in Heart Rate | 2.8 beats/min | Standard Deviation 5.2 |
| Phenylephrine 0.25% | Change in Heart Rate | 5.2 beats/min | Standard Deviation 6.6 |
| Lidocaine 1% Plus Epinephrine 1:100,000 | Change in Heart Rate | 7.5 beats/min | Standard Deviation 9.7 |
| Bacteriostatic 0.9% NaCL | Change in Heart Rate | 6.8 beats/min | Standard Deviation 5.6 |
p-value: 0.78Fisher Exact
p-value: 0.1Fisher Exact
p-value: 0.47Fisher Exact
Secondary
Change in Systolic Blood Pressure
Change from baseline in systolic blood pressure.
Time frame: baseline, 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxymetazoline 0.05% | Change in Systolic Blood Pressure | 7.5 mmHg | Standard Deviation 9.8 |
| Phenylephrine 0.25% | Change in Systolic Blood Pressure | 8.2 mmHg | Standard Deviation 7.2 |
| Lidocaine 1% Plus Epinephrine 1:100,000 | Change in Systolic Blood Pressure | 3.5 mmHg | Standard Deviation 6.5 |
| Bacteriostatic 0.9% NaCL | Change in Systolic Blood Pressure | 8.9 mmHg | Standard Deviation 5.4 |
p-value: 0.06Fisher Exact
p-value: 0.61Fisher Exact
p-value: 0.78Fisher Exact