Trial Outcomes & Findings for The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial. (NCT NCT02285634)
NCT ID: NCT02285634
Last Updated: 2018-10-02
Results Overview
Change in mean arterial blood pressure from the baseline measurement
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
baseline, 30 minutes
Results posted on
2018-10-02
Participant Flow
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.
None to report
Participant milestones
| Measure |
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.
|
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.
|
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.
|
Bacteriostatic 0.9% Sodium Chloride (NaCL)
Bacteriostatic 0.9% 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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
20
|
15
|
18
|
|
Overall Study
COMPLETED
|
15
|
20
|
11
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Oxymetazoline 0.05%
n=15 Participants
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.
|
Phenylephrine 0.25%
n=20 Participants
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.
|
Lidocaine 1% Plus Epinephrine 1:100,000
n=11 Participants
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.
|
Bacteriostatic 0.9% NaCL
n=17 Participants
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.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 15.0 • n=15 Participants
|
40.0 years
STANDARD_DEVIATION 16.8 • n=20 Participants
|
38.6 years
STANDARD_DEVIATION 15.7 • n=11 Participants
|
31.2 years
STANDARD_DEVIATION 10.1 • n=17 Participants
|
36.0 years
STANDARD_DEVIATION 14.4 • n=63 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=15 Participants
|
8 Participants
n=20 Participants
|
2 Participants
n=11 Participants
|
8 Participants
n=17 Participants
|
29 Participants
n=63 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=15 Participants
|
12 Participants
n=20 Participants
|
9 Participants
n=11 Participants
|
9 Participants
n=17 Participants
|
34 Participants
n=63 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
20 participants
n=20 Participants
|
11 participants
n=11 Participants
|
17 participants
n=17 Participants
|
63 participants
n=63 Participants
|
PRIMARY outcome
Timeframe: baseline, 30 minutesChange in mean arterial blood pressure from the baseline measurement
Outcome measures
| Measure |
Oxymetazoline 0.05%
n=15 Participants
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.
|
Phenylephrine 0.25%
n=20 Participants
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.
|
Lidocaine 1% Plus Epinephrine 1:100,000
n=11 Participants
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.
|
Bacteriostatic 0.9% NaCL
n=17 Participants
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.
|
|---|---|---|---|---|
|
Change in Mean Arterial Blood Pressure
|
5.1 mmHg
Standard Deviation 6.8
|
6.4 mmHg
Standard Deviation 5.8
|
4.6 mmHg
Standard Deviation 8.0
|
6.5 mmHg
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: baseline, 30 minutesChange from baseline in systolic blood pressure.
Outcome measures
| Measure |
Oxymetazoline 0.05%
n=15 Participants
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.
|
Phenylephrine 0.25%
n=20 Participants
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.
|
Lidocaine 1% Plus Epinephrine 1:100,000
n=11 Participants
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.
|
Bacteriostatic 0.9% NaCL
n=17 Participants
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.
|
|---|---|---|---|---|
|
Change in Systolic Blood Pressure
|
7.5 mmHg
Standard Deviation 9.8
|
8.2 mmHg
Standard Deviation 7.2
|
3.5 mmHg
Standard Deviation 6.5
|
8.9 mmHg
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: baseline, 30 minutesChange from baseline in diastolic blood pressure.
Outcome measures
| Measure |
Oxymetazoline 0.05%
n=15 Participants
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.
|
Phenylephrine 0.25%
n=20 Participants
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.
|
Lidocaine 1% Plus Epinephrine 1:100,000
n=11 Participants
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.
|
Bacteriostatic 0.9% NaCL
n=17 Participants
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.
|
|---|---|---|---|---|
|
Change in Diastolic Blood Pressure
|
5.7 mmHg
Standard Deviation 7.7
|
7.9 mmHg
Standard Deviation 6.8
|
6.2 mmHg
Standard Deviation 8.3
|
9.3 mmHg
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: baseline, 30 minutesChange from baseline in heart rate.
Outcome measures
| Measure |
Oxymetazoline 0.05%
n=15 Participants
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.
|
Phenylephrine 0.25%
n=20 Participants
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.
|
Lidocaine 1% Plus Epinephrine 1:100,000
n=11 Participants
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.
|
Bacteriostatic 0.9% NaCL
n=17 Participants
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.
|
|---|---|---|---|---|
|
Change in Heart Rate
|
2.8 beats/min
Standard Deviation 5.2
|
5.2 beats/min
Standard Deviation 6.6
|
7.5 beats/min
Standard Deviation 9.7
|
6.8 beats/min
Standard Deviation 5.6
|
Adverse Events
Oxymetazoline 0.05%
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phenylephrine 0.25%
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lidocaine 1% Plus Epinephrine 1:100,000
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bacteriostatic 0.9% NaCL
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxymetazoline 0.05%
n=15 participants at risk
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.
|
Phenylephrine 0.25%
n=20 participants at risk
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.
|
Lidocaine 1% Plus Epinephrine 1:100,000
n=11 participants at risk
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.
|
Bacteriostatic 0.9% NaCL
n=17 participants at risk
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.
|
|---|---|---|---|---|
|
General disorders
Nasal Pain
|
13.3%
2/15 • Number of events 2 • 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.
|
10.0%
2/20 • Number of events 2 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/17 • 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.
|
|
Eye disorders
Eye watering
|
6.7%
1/15 • Number of events 1 • 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.
|
0.00%
0/20 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/17 • 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.
|
|
General disorders
Diziness
|
0.00%
0/15 • 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.
|
5.0%
1/20 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/17 • 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.
|
|
General disorders
Unpleasant aftertaste
|
6.7%
1/15 • Number of events 1 • 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.
|
5.0%
1/20 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
11.8%
2/17 • Number of events 2 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place