The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.
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|ClinicalTrials.gov Identifier: NCT02285634|
Recruitment Status : Recruiting
First Posted : November 7, 2014
Last Update Posted : August 3, 2016
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.
What is the effect of commonly used intranasal vasoconstrictors on blood pressure in volunteers without a history of hypertension.
|Condition or disease||Intervention/treatment|
|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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: 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%
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.
- change mean arterial blood pressure [ Time Frame: 8 months ]Change in mean arterial blood pressure from the baseline measurement
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285634
|Contact: Tobias Kummer, MDemail@example.com|
|Contact: Michael Ferrara, MSfirstname.lastname@example.org|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Michael J Ferrara, MS 507-293-1239 email@example.com|
|Contact: Derek Vanmeter 507-255-5056 firstname.lastname@example.org|
|Principal Investigator:||Tobias Kummer, MD||Mayo Clinic|