Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures

January 13, 2020 updated by: SENDOA BALLESTEROS-PEÑA, Bionorte

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Bizkaia
      • Bilbao, Bizkaia, Spain
        • Hospital de Basurto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 +.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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:
  • Placebo
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:
  • Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
scores on a scale immediately after the puncture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bionorte

Collaborators

University of the Basque Country (UPV/EHU)
Osakidetza

Investigators

  • Principal Investigator: SENDOA BALLESTEROS-PEÑA, PhD, HOSPITAL OF BASURTO (BILBAO)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

October 9, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASOHUB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Alcohol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe