Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-01 @ 10:08 PM
Study NCT ID:
NCT02285634
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2014-11-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004844', 'term': 'Epistaxis'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vanmeter.derek@mayo.edu', 'phone': '507 255 4732', 'title': 'Dr. Tobias Kummer', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The primary limitation was the small sample size as enrollment was markedly more difficult than anticipated.'}}, 'adverseEventsModule': {'timeFrame': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Oxymetazoline 0.05%', 'description': 'Oxymetazoline 0.05%\n\nOxymetazoline 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.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 4, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phenylephrine 0.25%', 'description': 'Phenylephrine 0.25%\n\nPhenylephrine 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.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Lidocaine 1% Plus Epinephrine 1:100,000', 'description': 'Lidocaine 1% plus epinephrine 1:100,000\n\nLidocaine 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.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Bacteriostatic 0.9% NaCL', 'description': 'Bacteriostatic 0.9% sodium chloride (NaCL)\n\nBacteriostatic 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.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 2, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye watering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unpleasant aftertaste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Arterial Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxymetazoline 0.05%', 'description': 'Oxymetazoline 0.05%\n\nOxymetazoline 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.'}, {'id': 'OG001', 'title': 'Phenylephrine 0.25%', 'description': 'Phenylephrine 0.25%\n\nPhenylephrine 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.'}, {'id': 'OG002', 'title': 'Lidocaine 1% Plus Epinephrine 1:100,000', 'description': 'Lidocaine 1% plus epinephrine 1:100,000\n\nLidocaine 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.'}, {'id': 'OG003', 'title': 'Bacteriostatic 0.9% NaCL', 'description': 'Bacteriostatic 0.9% sodium chloride (NaCL)\n\nBacteriostatic 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '8.0', 'groupId': 'OG002'}, {'value': '6.5', 'spread': '5.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.52', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.93', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 30 minutes', 'description': 'Change in mean arterial blood pressure from the baseline measurement', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxymetazoline 0.05%', 'description': 'Oxymetazoline 0.05%\n\nOxymetazoline 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.'}, {'id': 'OG001', 'title': 'Phenylephrine 0.25%', 'description': 'Phenylephrine 0.25%\n\nPhenylephrine 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.'}, {'id': 'OG002', 'title': 'Lidocaine 1% Plus Epinephrine 1:100,000', 'description': 'Lidocaine 1% plus epinephrine 1:100,000\n\nLidocaine 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.'}, {'id': 'OG003', 'title': 'Bacteriostatic 0.9% NaCL', 'description': 'Bacteriostatic 0.9% sodium chloride (NaCL)\n\nBacteriostatic 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '6.5', 'groupId': 'OG002'}, {'value': '8.9', 'spread': '5.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.61', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.78', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 30 minutes', 'description': 'Change from baseline in systolic blood pressure.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxymetazoline 0.05%', 'description': 'Oxymetazoline 0.05%\n\nOxymetazoline 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.'}, {'id': 'OG001', 'title': 'Phenylephrine 0.25%', 'description': 'Phenylephrine 0.25%\n\nPhenylephrine 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.'}, {'id': 'OG002', 'title': 'Lidocaine 1% Plus Epinephrine 1:100,000', 'description': 'Lidocaine 1% plus epinephrine 1:100,000\n\nLidocaine 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.'}, {'id': 'OG003', 'title': 'Bacteriostatic 0.9% NaCL', 'description': 'Bacteriostatic 0.9% sodium chloride (NaCL)\n\nBacteriostatic 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '6.2', 'spread': '8.3', 'groupId': 'OG002'}, {'value': '9.3', 'spread': '6.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.17', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.56', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 30 minutes', 'description': 'Change from baseline in diastolic blood pressure.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxymetazoline 0.05%', 'description': 'Oxymetazoline 0.05%\n\nOxymetazoline 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.'}, {'id': 'OG001', 'title': 'Phenylephrine 0.25%', 'description': 'Phenylephrine 0.25%\n\nPhenylephrine 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.'}, {'id': 'OG002', 'title': 'Lidocaine 1% Plus Epinephrine 1:100,000', 'description': 'Lidocaine 1% plus epinephrine 1:100,000\n\nLidocaine 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.'}, {'id': 'OG003', 'title': 'Bacteriostatic 0.9% NaCL', 'description': 'Bacteriostatic 0.9% sodium chloride (NaCL)\n\nBacteriostatic 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '7.5', 'spread': '9.7', 'groupId': 'OG002'}, {'value': '6.8', 'spread': '5.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.10', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.47', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 30 minutes', 'description': 'Change from baseline in heart rate.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oxymetazoline 0.05%', 'description': 'Oxymetazoline 0.05%\n\nOxymetazoline 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.'}, {'id': 'FG001', 'title': 'Phenylephrine 0.25%', 'description': 'Phenylephrine 0.25%\n\nPhenylephrine 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.'}, {'id': 'FG002', 'title': 'Lidocaine 1% Plus Epinephrine 1:100,000', 'description': 'Lidocaine 1% plus epinephrine 1:100,000\n\nLidocaine 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.'}, {'id': 'FG003', 'title': 'Bacteriostatic 0.9% Sodium Chloride (NaCL)', 'description': 'Bacteriostatic 0.9% NaCL\n\nBacteriostatic 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': 'None to report'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxymetazoline 0.05%', 'description': 'Oxymetazoline 0.05%\n\nOxymetazoline 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.'}, {'id': 'BG001', 'title': 'Phenylephrine 0.25%', 'description': 'Phenylephrine 0.25%\n\nPhenylephrine 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.'}, {'id': 'BG002', 'title': 'Lidocaine 1% Plus Epinephrine 1:100,000', 'description': 'Lidocaine 1% plus epinephrine 1:100,000\n\nLidocaine 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.'}, {'id': 'BG003', 'title': 'Bacteriostatic 0.9% NaCL', 'description': 'Bacteriostatic 0.9% sodium chloride (NaCL)\n\nBacteriostatic 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.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '34.5', 'spread': '15.0', 'groupId': 'BG000'}, {'value': '40.0', 'spread': '16.8', 'groupId': 'BG001'}, {'value': '38.6', 'spread': '15.7', 'groupId': 'BG002'}, {'value': '31.2', 'spread': '10.1', 'groupId': 'BG003'}, {'value': '36.0', 'spread': '14.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-07', 'studyFirstSubmitDate': '2014-11-05', 'resultsFirstSubmitDate': '2018-09-07', 'studyFirstSubmitQcDate': '2014-11-06', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-07', 'studyFirstPostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Arterial Blood Pressure', 'timeFrame': 'baseline, 30 minutes', 'description': 'Change in mean arterial blood pressure from the baseline measurement'}], 'secondaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure', 'timeFrame': 'baseline, 30 minutes', 'description': 'Change from baseline in systolic blood pressure.'}, {'measure': 'Change in Diastolic Blood Pressure', 'timeFrame': 'baseline, 30 minutes', 'description': 'Change from baseline in diastolic blood pressure.'}, {'measure': 'Change in Heart Rate', 'timeFrame': 'baseline, 30 minutes', 'description': 'Change from baseline in heart rate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Epistaxis', 'Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '30195946', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.jemermed.2018.07.004', 'label': 'The Journal of Emergency Medicine'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nClassic 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.\n\nThough 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.\n\nClinical question:\n\nWhat is the effect of commonly used intranasal vasoconstrictors on blood pressure in volunteers without a history of hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers over the age of eighteen that have been recently dismissed from the Emergency Department at Mayo Clinic Hospital, Saint Marys Campus.\n* 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.\n\nExclusion Criteria:\n\n* We will exclude persons under the age of eighteen\n* Vulnerable populations (pregnant patients and prisoners)\n* Those with an allergy to any of the study agents\n* Those with acute pain\n* Those using antihypertensive or antiarrhythmic agents\n* Those with significant cardiopulmonary comorbidities (namely history of arrhythmia, coronary artery disease, hypertension, and heart failure)\n* Those with concomitant use of Monoamine oxidase A (MAO) Inhibitors\n* Those with a diagnosis of angle closure glaucoma or benign prostatic hyperplasia (BPH)\n* Those with a history of cerebrovascular disease\n* As well as those with a history of previous nasal surgery or known nasal anatomic abnormalities.'}, 'identificationModule': {'nctId': 'NCT02285634', 'briefTitle': 'The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial.', 'orgStudyIdInfo': {'id': '14-006312'}, 'secondaryIdInfos': [{'id': 'UL1TR000135', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR000135', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxymetazoline 0.05%', 'description': 'Oxymetazoline 0.05%', 'interventionNames': ['Drug: Oxymetazoline 0.05%']}, {'type': 'EXPERIMENTAL', 'label': 'Phenylephrine 0.25%', 'description': 'Phenylephrine 0.25%', 'interventionNames': ['Drug: Phenylephrine 0.25%']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine 1% plus epinephrine 1:100,000', 'description': 'Lidocaine 1% plus epinephrine 1:100,000', 'interventionNames': ['Drug: Lidocaine 1% plus epinephrine 1:100,000']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Bacteriostatic 0.9% sodium chloride (NaCL)', 'description': 'Bacteriostatic 0.9% NaCL', 'interventionNames': ['Drug: Bacteriostatic 0.9% NaCL']}], 'interventions': [{'name': 'Oxymetazoline 0.05%', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Oxymetazoline 0.05%']}, {'name': 'Phenylephrine 0.25%', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Phenylephrine 0.25%']}, {'name': 'Lidocaine 1% plus epinephrine 1:100,000', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Lidocaine 1% plus epinephrine 1:100,000']}, {'name': 'Bacteriostatic 0.9% NaCL', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Bacteriostatic 0.9% sodium chloride (NaCL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Tobias Kummer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Emergency Medicine', 'investigatorFullName': 'Tobias Kummer', 'investigatorAffiliation': 'Mayo Clinic'}}}}