Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures

NCT ID: NCT02587143

Last Updated: 2020-01-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anesthesia Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

Alcohol -based spray as placebo will be administrated before arterial puncture.

Group Type ACTIVE_COMPARATOR

Alcohol

Intervention Type DRUG

Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture (of cubital arteria).

Ethyl chloride

Ethyl choride will be administrated before arterial puncture.

Group Type EXPERIMENTAL

Ethyl chloride

Intervention Type DRUG

Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture (of cubital arteria).

Interventions

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Ethyl chloride

Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture (of cubital arteria).

Intervention Type DRUG

Alcohol

Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture (of cubital arteria).

Intervention Type DRUG

Other Intervention Names

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Intervention Placebo

Eligibility Criteria

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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 +.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Osakidetza

OTHER

Sponsor Role collaborator

University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role collaborator

Bionorte

OTHER

Sponsor Role lead

Responsible Party

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SENDOA BALLESTEROS-PEÑA

Emergency nurse practitioner, PhD doctor.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SENDOA BALLESTEROS-PEÑA, PhD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL OF BASURTO (BILBAO)

Locations

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Hospital de Basurto

Bilbao, Bizkaia, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 28825235 (View on PubMed)

Other Identifiers

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GASOHUB

Identifier Type: -

Identifier Source: org_study_id

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