NCT02587143

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

January 22, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

October 9, 2015

Results QC Date

August 7, 2017

Last Update Submit

January 13, 2020

Conditions

AnesthesiaPain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Drug: Alcohol

Ethyl chloride

EXPERIMENTAL

Ethyl choride will be administrated before arterial puncture.

Drug: Ethyl chloride

Interventions

Ethyl chlorideDRUG

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

Also known as: Intervention
Ethyl chloride
AlcoholDRUG

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

Also known as: Placebo
Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age: 18-85 years old.
  • arterial gasometry determination needed
  • III, IV or V level classification on Manchester triage.

You may not qualify if:

  • 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 +.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Basurto

Bilbao, Bizkaia, Spain

Location

Related Publications (1)

  • 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.

    PMID: 28825235RESULT

MeSH Terms

Conditions

Pain

Interventions

Ethyl ChlorideMethodsEthanol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrocarbons, ChlorinatedHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsInvestigative TechniquesAlcohols

Results Point of Contact

Title
Dr. Ballesteros-Peña
Organization
Servicio de Urgencias, Hospital de Basurto, Bilbao, España
sendoa.ballesteros@ehu.eus
(+34)946012804

Study Officials

  • SENDOA BALLESTEROS-PEÑA, PhD

    HOSPITAL OF BASURTO (BILBAO)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency nurse practitioner, PhD doctor.

Study Record Dates

First Submitted

October 9, 2015

First Posted

October 27, 2015

Study Start

February 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 22, 2020

Results First Posted

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)