Vapocoolant Spray Used Prior to Intravenous (IV) Insertions

Aultman Health Foundation

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Nature's Tears; Drug: Gebauer Ethyl Chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03054740

AultmanHF

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Gebauer Ethyl Chloride

Active Comparator group

Description:

Device: Vapocoolant (Ethyl Chloride Mist Spray)

Treatment:

Drug: Gebauer Ethyl Chloride

Nature's Tears

Placebo Comparator group

Description:

Device: Sterile Water

Treatment:

Drug: Nature's Tears