Trial Outcomes & Findings for Vapocoolant Spray Used Prior to Intravenous (IV) Insertions (NCT NCT03054740)
NCT ID: NCT03054740
Last Updated: 2018-10-03
Results Overview
0-No Pain; 1-3 Mild Pain; 4-6 Moderate-Severe Pain; 7-9 Very Severe Pain;10 Worst Possible Pain
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
less than 5 minutes following spray application
Results posted on
2018-10-03
Participant Flow
Participant milestones
| Measure |
Gebauer Ethyl Chloride
Device: Vapocoolant (Ethyl Chloride Mist Spray)
Gebauer Ethyl Chloride: Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds.
|
Nature's Tears
Device: Sterile Water
Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Gebauer Ethyl Chloride
n=15 Participants
Device: Vapocoolant (Ethyl Chloride Mist Spray)
Gebauer Ethyl Chloride: Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds.
|
Nature's Tears
n=15 Participants
Device: Sterile Water
Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=15 Participants
|
8 Participants
n=15 Participants
|
20 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
10 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=15 Participants
|
8 Participants
n=15 Participants
|
15 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
15 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: less than 5 minutes following spray application0-No Pain; 1-3 Mild Pain; 4-6 Moderate-Severe Pain; 7-9 Very Severe Pain;10 Worst Possible Pain
Outcome measures
| Measure |
Gebauer Ethyl Chloride
n=15 Participants
Device: Vapocoolant (Ethyl Chloride Mist Spray)
Gebauer Ethyl Chloride: Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds.
|
Nature's Tears
n=15 Participants
Device: Sterile Water
Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access
|
|---|---|---|
|
Pain Scale Using Visual Analog Scale
|
1.13 score on a scale
Standard Deviation 1.302
|
1.60 score on a scale
Standard Deviation 1.639
|
SECONDARY outcome
Timeframe: less than 5 minutes following spray application1-Very Satisfied; 2-Somewhat Satisfied; 3-Neither Satisfied or Dissatisfied; 4-Somewhat Satisfied; 5-Very Satisfied
Outcome measures
| Measure |
Gebauer Ethyl Chloride
n=15 Participants
Device: Vapocoolant (Ethyl Chloride Mist Spray)
Gebauer Ethyl Chloride: Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds.
|
Nature's Tears
n=15 Participants
Device: Sterile Water
Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access
|
|---|---|---|
|
Satisfaction Scale Using 1-5 Likert Scale
Somewhat Satisfied
|
2 Participants
|
5 Participants
|
|
Satisfaction Scale Using 1-5 Likert Scale
Very Satisified
|
13 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: At baseline prior to spray application1-5 Likert Scale 1 very dissatisfied, 2 somewhat dissatisfied, 3 neither satisfied or dissatisfied, 4 somewhat satisfied, 5 very satisfied
Outcome measures
| Measure |
Gebauer Ethyl Chloride
n=15 Participants
Device: Vapocoolant (Ethyl Chloride Mist Spray)
Gebauer Ethyl Chloride: Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds.
|
Nature's Tears
n=15 Participants
Device: Sterile Water
Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access
|
|---|---|---|
|
Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted
Very Dissatisified
|
1 Participants
|
0 Participants
|
|
Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted
Somewhat Dissatisfied
|
2 Participants
|
1 Participants
|
|
Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted
Neither Satisified or Dissatisfied
|
0 Participants
|
1 Participants
|
|
Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted
Somewhat Satisfied
|
10 Participants
|
12 Participants
|
|
Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted
Very Satisfied
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At baseline prior to spray applicationVisual Analog Scale 0 no pain, 1-2 mild, 3-5 moderate, 6 severe, 7-8 very severe, 9-10 worst possible pain
Outcome measures
| Measure |
Gebauer Ethyl Chloride
n=15 Participants
Device: Vapocoolant (Ethyl Chloride Mist Spray)
Gebauer Ethyl Chloride: Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds.
|
Nature's Tears
n=15 Participants
Device: Sterile Water
Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access
|
|---|---|---|
|
Using the Same Visual Analog Scale Rate Pain the Last Time the Patient Remembers Having an IV Inserted
|
3.40 score on a scale
Standard Deviation 2.746
|
2.87 score on a scale
Standard Deviation 2.031
|
SECONDARY outcome
Timeframe: less than 10 minutes following spray applicationYes or No question
Outcome measures
| Measure |
Gebauer Ethyl Chloride
n=15 Participants
Device: Vapocoolant (Ethyl Chloride Mist Spray)
Gebauer Ethyl Chloride: Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds.
|
Nature's Tears
n=15 Participants
Device: Sterile Water
Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access
|
|---|---|---|
|
Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed
Yes
|
12 Participants
|
8 Participants
|
|
Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed
No
|
3 Participants
|
7 Participants
|
Adverse Events
Gebauer Ethyl Chloride
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nature's Tears
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place