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| Name | Class |
|---|---|
| Osakidetza | OTHER |
| University of the Basque Country (UPV/EHU) | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Alcohol -based spray as placebo will be administrated before arterial puncture. |
|
| Ethyl chloride | Experimental | Ethyl choride will be administrated before arterial puncture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethyl chloride | Drug | Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture (of cubital arteria). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Level on the Visual Analog Scale (NRS-11) | 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 | scores on a scale immediately after the puncture |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SENDOA BALLESTEROS-PEÑA, PhD | HOSPITAL OF BASURTO (BILBAO) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Basurto | Bilbao | Bizkaia | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28825235 | Result | Ballesteros-Pena S, Fernandez-Aedo I, Vallejo-De la Hoz G; en representacion del Grupo de Trabajo DIASURE. [Ethyl chloride aerosol spray for local anesthesia before arterial puncture: randomized placebo-controlled trial]. Emergencias. 2017 Jun;29(3):161-166. Spanish. |
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Seccondary effcts happens after punctre (dizziness...)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Ethyl Chloride |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Level on the Visual Analog Scale (NRS-11) | 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 | Posted | Median | Inter-Quartile Range | scores on scale | scores on a scale immediately after the puncture |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 (of cubital arteria). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local injury (ischaemia) | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ballesteros-Peña | Servicio de Urgencias, Hospital de Basurto, Bilbao, España | (+34)946012804 | sendoa.ballesteros@ehu.eus |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005018 | Ethyl Chloride |
| D008722 | Methods |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D006843 | Hydrocarbons, Chlorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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|
| Alcohol | Drug | 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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Arteria of puncture | Puncture on humeral arteria or cubital arteria | Count of Participants | Participants |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | 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 (of cubital arteria). | 0 | 66 | 1 | 66 |
| Dizziness after puncture | General disorders | Non-systematic Assessment |
|
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| D008919 |
| Investigative Techniques |
| D000438 | Alcohols |