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Completed

NCT Number: NCT02587143

Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures

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.

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Key information

Conditions

Anesthesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Basurto

Bilbao, Bizkaia, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 +.

Treatment and study plan

Ethyl chloride

Drug

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

Other names: Intervention

Alcohol

Drug

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

Other names: Placebo

Primary outcomes

  1. Pain Level on the Visual Analog Scale (NRS-11)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bionorte

Other

Collaborators

  • Osakidetza
  • University of the Basque Country (UPV/EHU)

Registry information

Official study title

Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures: A Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 27, 2015
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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