EpistaxisNCT02285634
The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.
A study testing Oxymetazoline 0.05%, Phenylephrine 0.25% and Lidocaine 1% plus epinephrine 1:100,000 in people with Epistaxis and Blood Pressure, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epistaxis, Blood Pressure
- What is being tested?
- Oxymetazoline 0.05%, Phenylephrine 0.25% and Lidocaine 1% plus epinephrine 1:100,000
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 22 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read more
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.
- Conditions
- Epistaxis, Blood Pressure
- Being tested
- Oxymetazoline 0.05%, Phenylephrine 0.25%, Lidocaine 1% plus epinephrine 1:100,000, Bacteriostatic 0.9% NaCL
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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 1:100,000Drug
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% NaCLDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Oxymetazoline 0.05% | Experimental | Oxymetazoline 0.05% Receives: Drug: Oxymetazoline 0.05% |
| Phenylephrine 0.25% | Experimental | Phenylephrine 0.25% Receives: Drug: Phenylephrine 0.25% |
| Lidocaine 1% plus epinephrine 1:100,000 | Experimental | Lidocaine 1% plus epinephrine 1:100,000 Receives: Drug: Lidocaine 1% plus epinephrine 1:100,000 |
| Bacteriostatic 0.9% sodium chloride (NaCL) | Placebo comparator | Bacteriostatic 0.9% NaCL Receives: Drug: Bacteriostatic 0.9% NaCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Arterial Blood Pressure
Change in mean arterial blood pressure from the baseline measurement
Measured: baseline, 30 minutes
Secondary outcomes (3)
Change in Systolic Blood Pressure
Change from baseline in systolic blood pressure.
Measured: baseline, 30 minutes
Change in Diastolic Blood Pressure
Change from baseline in diastolic blood pressure.
Measured: baseline, 30 minutes
Change in Heart Rate
Change from baseline in heart rate.
Measured: baseline, 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion22 Dec 2016
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpistaxisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Kummer, Mayo Clinic
- Investigators
- Tobias Kummer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285634
- Sponsor's protocol ID
- 14-006312
- Other IDs
- UL1TR000135
- Status last verified
- Sep 2018
- First submitted
- 5 Nov 2014
- Last updated
- 2 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 30195946
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT02285634
- Acronym / sponsor ID
- 14-006312
- Conditions
- Epistaxis, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Posted 2 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oxymetazoline 0.05% | Experimental | Drug: Oxymetazoline 0.05%Oxymetazoline 0.05% |
| Phenylephrine 0.25% | Experimental | Drug: Phenylephrine 0.25%Phenylephrine 0.25% |
| Lidocaine 1% plus epinephrine 1:100,000 | Experimental | Drug: Lidocaine 1% plus epinephrine 1:100,000Lidocaine 1% plus epinephrine 1:100,000 |
| Bacteriostatic 0.9% sodium chloride (NaCL) | Placebo comparator | Drug: Bacteriostatic 0.9% NaCLBacteriostatic 0.9% NaCL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Oxymetazoline 0.05% |
| 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. | Drug | Phenylephrine 0.25% |
| Lidocaine 1% plus epinephrine 1:100,000sterile 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. | Drug | Lidocaine 1% plus epinephrine 1:100,000 |
| Bacteriostatic 0.9% NaCLsterile 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. | Drug | Bacteriostatic 0.9% sodium chloride (NaCL) |
Primary outcome
Change in Mean Arterial Blood Pressure
Time frame: baseline, 30 minutes
Change in mean arterial blood pressure from the baseline measurement
3 secondary outcomes
Change in Systolic Blood Pressure
Time frame: baseline, 30 minutes
Change in Diastolic Blood Pressure
Time frame: baseline, 30 minutes
Change in Heart Rate
Time frame: baseline, 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30195946Bellew 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.
- The Journal of Emergency MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Epistaxis
Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia
Not yet recruitingPhase 2
Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
Chronic Rhinosinusitis, Intraoperative Bleeding
Recruiting
Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
Deviated Nasal Septum, Postoperative Nasal Pain
RecruitingPhase 3
RADA16 for Adult Tonsillectomy
Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Kummer, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxymetazoline 0.05%, Phenylephrine 0.25% and Lidocaine 1% plus epinephrine 1:100,000 in people with Epistaxis and Blood Pressure, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Arterial Blood Pressure (time frame: baseline, 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02285634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.