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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-006312
    NCT ID: NCT02285634
    Sponsor Protocol Number: 14-006312

About this study

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 MAO-Inhibitors
  • Those with a diagnosis of angle closure glaucoma or BPH
  • Those with a history of cerebrovascular disease
  • As well as those with a history of previous nasal surgery or known nasal anatomic abnormalities.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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 MAO-Inhibitors
  • Those with a diagnosis of angle closure glaucoma or BPH
  • Those with a history of cerebrovascular disease
  • As well as those with a history of previous nasal surgery or known nasal anatomic abnormalities.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Tobias Kummer, M.D.

Closed for enrollment

Contact information:

Tobias Kummer M.D.

507-255-4399

Kummer.Tobias@mayo.edu

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CLS-20144045

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