Anesthesia, Pain
Conditions
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.
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.
Interventions
DRUGEthyl chloride
Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture (of cubital arteria).
DRUGAlcohol
Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture (of cubital arteria).
Sponsors
Osakidetza
University of the Basque Country (UPV/EHU)
Bionorte
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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 +.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level on the Visual Analog Scale (NRS-11) | 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 |
Countries
Spain
Participant flow
Pre-assignment details
Seccondary effcts happens after punctre (dizziness...)
Participants by arm
| Arm | Count |
|---|---|
| Control Alcohol -based spray as placebo will be administrated before arterial puncture.
Alcohol: Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture. | 60 |
| Ethyl Chloride Ethyl choride will be administrated before arterial puncture.
Ethyl chloride: Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture. | 66 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Ethyl Chloride | Total | Control |
|---|---|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 14.4 | 67.9 years STANDARD_DEVIATION 13.3 | 68.7 years STANDARD_DEVIATION 12.1 |
| Arteria of puncture Cubital arteria | 56 Participants | 106 Participants | 50 Participants |
| Arteria of puncture Humeral arteria | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Female | 25 Participants | 47 Participants | 22 Participants |
| Sex: Female, Male Male | 41 Participants | 79 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 1 / 66 |
| serious Total, serious adverse events | 0 / 60 | 0 / 66 |
Outcome results
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
Time frame: scores on a scale immediately after the puncture
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Pain Level on the Visual Analog Scale (NRS-11) | 2 scores on scale |
| Ethyl Chloride | Pain Level on the Visual Analog Scale (NRS-11) | 2 scores on scale |