Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures
Study Details
Study Description
Brief Summary
Ethyl chloride vapocoolant sprays provide transient skin anesthesia within seconds of application. The current investigation aim is to compare the effect of ethyl chloride based vapocoolant spray to placebo in reducing pain associated with arterial puncture for gasometry determinations.
The investigators will conduce a double-blind randomized placebo-controlled trial at Emergency Department.
We will enroll patients who come to Emergency Department who need an arterial gasometry determination. Patients will be randomized to intervention-group (ethyl chloride vapocoolant sprays will be usad before arterial puncture) or to placebo-group (alcohol spray as placebo will be used before arterial puncture.) and after the puncture they will rate their pain using a 10 points visual analogue scale.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Single-blind, randomized placebo-controlled trial in an emergency department of Hospital de Basurto in Bilbao, Spain. Patients for whom arterial blood gas analysis had been ordered will be included. They will be randomly assigned to receive application of the experimental ethyl chloride spray or a placebo aerosol spray of a solution of alcohol in water. The assigned spray will be applied just before arterial puncture. The main outcome variable is pain intensity reported on an 11-point numeric rating scale.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Control Alcohol -based spray as placebo will be administrated before arterial puncture. |
Drug: Alcohol
Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture (of cubital arteria).
Other Names:
|
| Experimental: Ethyl chloride Ethyl choride will be administrated before arterial puncture. |
Drug: Ethyl chloride
Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture (of cubital arteria).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pain Level on the Visual Analog Scale (NRS-11) [scores on a scale immediately after the puncture]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age: 18-85 years old.
-
arterial gasometry determination needed
-
III, IV or V level classification on Manchester triage.
Exclusion criteria:
-
refusal to participate,
-
inability to provide informed consent (non-Spanish speaking, dementia or altered mental state),
-
skin disease associated with cold intolerance (Raynaud's phenomenon),
-
known allergy to spray contents,
-
Glasgow Coma Scale <15,
-
pregnancy,
-
under effects of alcohol or drugs,
-
Allen test +.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital de Basurto | Bilbao | Bizkaia | Spain |
Sponsors and Collaborators
- Bionorte
- Osakidetza
- University of the Basque Country (UPV/EHU)
Investigators
- Principal Investigator: SENDOA BALLESTEROS-PEÑA, PhD, HOSPITAL OF BASURTO (BILBAO)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GASOHUB
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Seccondary effcts happens after punctre (dizziness...) |
| Arm/Group Title | Ethyl Chloride | Control |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 66 | 60 |
| COMPLETED | 65 | 60 |
| NOT COMPLETED | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Control | Ethyl Chloride | Total |
|---|---|---|---|
| Arm/Group Description | 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 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 of all reporting groups |
| Overall Participants | 60 | 66 | 126 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
68.7
(12.1)
|
67.1
(14.4)
|
67.9
(13.3)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
22
36.7%
|
25
37.9%
|
47
37.3%
|
| Male |
38
63.3%
|
41
62.1%
|
79
62.7%
|
| Arteria of puncture (Count of Participants) | |||
| Cubital arteria |
50
83.3%
|
56
84.8%
|
106
84.1%
|
| Humeral arteria |
10
16.7%
|
10
15.2%
|
20
15.9%
|
Outcome Measures
| Title | Pain Level on the Visual Analog Scale (NRS-11) |
|---|---|
| Description | 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 |
| Time Frame | scores on a scale immediately after the puncture |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Ethyl Chloride |
|---|---|---|
| Arm/Group Description | 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 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. |
| Measure Participants | 60 | 66 |
| Median (Inter-Quartile Range) [scores on scale] |
2
|
2
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Control | Ethyl Chloride | ||
| Arm/Group Description | 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 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). | ||
All Cause Mortality |
||||
| Control | Ethyl Chloride | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Control | Ethyl Chloride | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | 0/66 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Control | Ethyl Chloride | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | 1/66 (1.5%) | ||
| General disorders | ||||
| Dizziness after puncture | 0/60 (0%) | 1/66 (1.5%) | ||
| Vascular disorders | ||||
| Local injury (ischaemia) | 0/60 (0%) | 0 | 0/66 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Ballesteros-Peña |
|---|---|
| Organization | Servicio de Urgencias, Hospital de Basurto, Bilbao, España |
| Phone | (+34)946012804 |
| sendoa.ballesteros@ehu.eus |
- GASOHUB