AnesthesiaNCT02587143
Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures
A study testing Ethyl chloride and Alcohol in people with Anesthesia and Pain, run by Bionorte at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anesthesia, Pain
- What is being tested?
- Ethyl chloride and Alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: 18-85 years old.
- arterial gasometry determination needed
- III, IV or V level classification on Manchester triage.
Who cannot join
- 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 +.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia, Pain
- Being tested
- Ethyl chloride, Alcohol
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethyl chlorideDrug
Also called Intervention
Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture (of cubital arteria).
AlcoholDrug
Also called Placebo
Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture (of cubital arteria).
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Alcohol -based spray as placebo will be administrated before arterial puncture. Receives: Drug: Alcohol |
| Ethyl chloride | Experimental | Ethyl choride will be administrated before arterial puncture. Receives: Drug: Ethyl chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: scores on a scale immediately after the puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionorte
- Sponsor type
- University, hospital or other
- Collaborators
- Osakidetza, University of the Basque Country (UPV/EHU)
- Responsible party
- Principal investigator, SENDOA BALLESTEROS-PEÑA, Bionorte
- Investigators
- SENDOA BALLESTEROS-PEÑA, PhD, Principal investigator, HOSPITAL OF BASURTO (BILBAO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587143
- Sponsor's protocol ID
- GASOHUB
- Status last verified
- Jan 2020
- First submitted
- 9 Oct 2015
- Last updated
- 22 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28825235
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02587143
- Acronym / sponsor ID
- GASOHUB
- Conditions
- Anesthesia, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- BionorteUniversity, hospital or other
- Collaborators
- Osakidetza, University of the Basque Country (UPV/EHU)
- Study start
- Feb 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: AlcoholAlcohol -based spray as placebo will be administrated before arterial puncture. |
| Ethyl chloride | Experimental | Drug: Ethyl chlorideEthyl choride will be administrated before arterial puncture. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age: 18-85 years old.
- arterial gasometry determination needed
- III, IV or V level classification on Manchester triage.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethyl chlorideAlso: InterventionNurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture (of cubital arteria). | Drug | Ethyl chloride |
| AlcoholAlso: PlaceboNurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture (of cubital arteria). | Drug | Control |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28825235Ballesteros-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SENDOA BALLESTEROS-PEÑA, PhD principal investigator
HOSPITAL OF BASURTO (BILBAO)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethyl chloride and Alcohol in people with Anesthesia and Pain, run by Bionorte at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level on the Visual Analog Scale (NRS-11) (time frame: scores on a scale immediately after the puncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02587143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.