Vapocoolant Spray Effectiveness On Arterial Puncture Pain: Randomized Double Blind Placebo-Controlled Trial

Study Overview
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Brief Summary
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This study was aimed to compare pain levels from arterial blood gas (ABG) sampling performed with vapocoolant spray in comparison to placebo.

Detailed Description
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Previous studies of vapocoolant sprays for reducing pain were mainly on venopuncture with inconsistent results. There was only one prospective open labeled controlled study on arterial blood gas sampling with ethyl chloride which did not show effectiveness. This study will assess the efficacy and tolerability of a topical alkane vapocoolant spray for arterial puncture in adults in comparison to control spray.

Official Title
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Topical Alkane Vapocoolant Spray Effectiveness On Arterial Puncture Pain Reduction In Emergency Department: Randomized Double Blind Placebo-Controlled Trial

Conditions
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Puncture Site Pain

Intervention / Treatment
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* Drug: Vapocoolant spray
* Drug: Water spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age of 14 years or older, needs ABG as a part of their diagnosis Exclusion Criteria: history of analgesic medication used within 24 hours of enrollment, any sign of decreased consciousness, history of skin hypersensitivity, inability to report a pain score, history of a known neurological problem that changes pain perception, history of cold related reactions (e.g. Raynaud's phenomenon, cold urticaria), abnormal Allen's test

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vapocoolant spray<br>Vapocoolant is administered in 20 centimeters distance for 20 seconds to the patients as anesthetic before ABG. | Drug: Vapocoolant spray<br>* The Vapocoolant spray containing alkane is applied for 20 seconds.<br>* Other names: Cryoanesthetic;|
| Placebo Comparator: Water spray<br>The Patients in this arm will receive water spray as anesthetic before ABG. | Drug: Water spray<br>* This spray is covered so the patient and the investigator can not find the spray type out.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| puncture pain | 30 seconds after ABG was performed, the patients would be asked about the puncture pain in verbal numerical pain scale. | 30 seconds after ABG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vapocoolant application pain | 30 seconds after ABG was performed, the patients would be asked about the spray application pain in verbal numerical pain scale. | 30 seconds affter procedure completion | 
| number of puncture attempts | The number of ABG sampling attempts is recorded 30 seconds after procedure. | 30 seconds after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vapocoolant effectiveness, arterial puncture