Vapocoolant Spray Used Prior to Intravenous (IV) Insertions

Aultman Health Foundation30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pain

Interventions

Gebauer Ethyl ChlorideDRUG

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 TearsDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Aultman Health Foundation

Canton, Ohio, United States

Outcomes

Primary Outcomes

Pain Scale Using Visual Analog Scale

0-No Pain; 1-3 Mild Pain; 4-6 Moderate-Severe Pain; 7-9 Very Severe Pain;10 Worst Possible Pain

Time frame: less than 5 minutes following spray application

Secondary Outcomes

Satisfaction Scale Using 1-5 Likert Scale

1-Very Satisfied; 2-Somewhat Satisfied; 3-Neither Satisfied or Dissatisfied; 4-Somewhat Satisfied; 5-Very Satisfied

Time frame: less than 5 minutes following spray application

Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted

1-5 Likert Scale 1 very dissatisfied, 2 somewhat dissatisfied, 3 neither satisfied or dissatisfied, 4 somewhat satisfied, 5 very satisfied

Time frame: At baseline prior to spray application

Using the Same Visual Analog Scale Rate Pain the Last Time the Patient Remembers Having an IV Inserted

Visual Analog Scale 0 no pain, 1-2 mild, 3-5 moderate, 6 severe, 7-8 very severe, 9-10 worst possible pain

Time frame: At baseline prior to spray application

Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed

Yes or No question

Time frame: less than 10 minutes following spray application

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.