Vapocoolant Spray Used Prior to Intravenous (IV) Insertions

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-27

Study Completion Date

2017-04-28

Brief Summary

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The primary purpose of this study is to determine if by offering a vapocoolant (cold spray) to hospital outpatients prior to an intravenous catheter (IV) insertion will increase patient satisfaction of IV insertion as well as determine if pain of insertion is decreased.

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Detailed Description

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This is a single blind interventional study with a post design using a convenience sample of patients undergoing a Nuclear Medicine Stress Test. The patient selection and intervention will be randomized in order to ensure a high validity study. The interventional treatment used will be a ethyl chloride mist spray manufactured by the Gebauer Company. The placebo spray that will be used is manufactured by BioLogic Aqua Research Technologies International Inc. The spray is called Nature's Tears Mist and is a sterile water. The patient's for this study are required to have intravenous cannulation (IV) access. This is a painful and invasive procedure in which a vapocoolant may confer benefit for the relief of pain.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Gebauer Ethyl Chloride

Device: Vapocoolant (Ethyl Chloride Mist Spray)

Group Type ACTIVE_COMPARATOR

Gebauer Ethyl Chloride

Intervention Type DRUG

Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds.

Nature's Tears

Device: Sterile Water

Group Type PLACEBO_COMPARATOR

Nature's Tears

Intervention Type DRUG

Sterile water mist will be administered 1-2 sprays prior to intravenous access

Interventions

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Gebauer Ethyl Chloride

Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds.

Intervention Type DRUG

Nature's Tears

Sterile water mist will be administered 1-2 sprays prior to intravenous access

Intervention Type DRUG

Other Intervention Names

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Ethyl Chloride Mist Spray Can Sterile Water

Eligibility Criteria

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Inclusion Criteria

* Any outpatient ordered to undergo a Nuclear Medicine Stress Test and is required to have IV access for injection of Radiopharmaceuticals

Exclusion Criteria

* If it is the first time the patient has had an intravenous catheter inserted
* Any patient who is or may be pregnant
* Any patient who is breast-feeding
* Any patient who has taken a narcotic, sedative and/or anti-anxiety medication within 8 hours of intervention time.
* Any patient who has a known diagnosis of Raynaud's Syndrome or Carpal Tunnel Syndrome.
* Any patient who has an allergy or hypersensitivity to Ethyl Chloride.
* Any patient under the age of 18 and/or any patient over the age of 85
* Any patient who is illiterate
* Any patient who is non-English speaking
* Any patient with prior experience with a vapocoolant spray.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes