Trial Outcomes & Findings for Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures (NCT NCT02587143)
NCT ID: NCT02587143
Last Updated: 2020-01-22
Results Overview
patients will measure their pain score on a visual analog scale (NRS-11: Numeric Rate Score, from 0 -no pain- to 10 points -the worst pain ever-) after the puncture
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
scores on a scale immediately after the puncture
Results posted on
2020-01-22
Participant Flow
Seccondary effcts happens after punctre (dizziness...)
Participant milestones
| Measure |
Ethyl Chloride
Ethyl choride will be administrated before arterial puncture.
Ethyl chloride: Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture.
|
Control
Alcohol -based spray as placebo will be administrated before arterial puncture.
Alcohol: Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
60
|
|
Overall Study
COMPLETED
|
65
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Ethyl Chloride
Ethyl choride will be administrated before arterial puncture.
Ethyl chloride: Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture.
|
Control
Alcohol -based spray as placebo will be administrated before arterial puncture.
Alcohol: Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures
Baseline characteristics by cohort
| Measure |
Control
n=60 Participants
Alcohol -based spray as placebo will be administrated before arterial puncture.
Alcohol: Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture.
|
Ethyl Chloride
n=66 Participants
Ethyl choride will be administrated before arterial puncture.
Ethyl chloride: Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.7 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
67.1 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
67.9 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Arteria of puncture
Cubital arteria
|
50 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Arteria of puncture
Humeral arteria
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: scores on a scale immediately after the puncturepatients will measure their pain score on a visual analog scale (NRS-11: Numeric Rate Score, from 0 -no pain- to 10 points -the worst pain ever-) after the puncture
Outcome measures
| Measure |
Control
n=60 Participants
Alcohol -based spray as placebo will be administrated before arterial puncture.
Alcohol: Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture.
|
Ethyl Chloride
n=66 Participants
Ethyl choride will be administrated before arterial puncture.
Ethyl chloride: Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture.
|
|---|---|---|
|
Pain Level on the Visual Analog Scale (NRS-11)
|
2 scores on scale
Interval 1.0 to 4.5
|
2 scores on scale
Interval 1.0 to 5.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ethyl Chloride
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=60 participants at risk
Alcohol -based spray as placebo will be administrated before arterial puncture.
Alcohol: Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture (of cubital arteria).
|
Ethyl Chloride
n=66 participants at risk
Ethyl choride will be administrated before arterial puncture.
Ethyl chloride: Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture (of cubital arteria).
|
|---|---|---|
|
Vascular disorders
Local injury (ischaemia)
|
0.00%
0/60
|
0.00%
0/66
|
|
General disorders
Dizziness after puncture
|
0.00%
0/60
|
1.5%
1/66
|
Additional Information
Dr. Ballesteros-Peña
Servicio de Urgencias, Hospital de Basurto, Bilbao, España
Phone: (+34)946012804
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place