Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587143
• Other study ID #: GASOHUB
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: January 2017

Study information

• Verified date: January 2020
• Source: Bionorte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 +.

Related Conditions & MeSH terms

• Anesthesia
• Pain

Intervention

Drug:
• Ethyl chloride
Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture (of cubital arteria).
• Alcohol
Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture (of cubital arteria).

Locations

Country	Name	City	State
Spain	Hospital de Basurto	Bilbao	Bizkaia

Sponsors (3)

Lead Sponsor	Collaborator
Bionorte	Basque Country University, Osakidetza

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Ballesteros-Peña S, Fernández-Aedo I, Vallejo-De la Hoz G; en representación del Grupo de Trabajo DIASURE. [Ethyl chloride aerosol spray for local anesthesia before arterial puncture: randomized placebo-controlled trial]. Emergencias. 2017 Jun;29(3):161-1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	scores on a scale immediately after the puncture