Vapocoolant Spray Used Prior to Intravenous (IV) Insertions
- Registration Number
- NCT03054740
- Lead Sponsor
- Aultman Health Foundation
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Any outpatient ordered to undergo a Nuclear Medicine Stress Test and is required to have IV access for injection of Radiopharmaceuticals
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gebauer Ethyl Chloride Gebauer Ethyl Chloride Device: Vapocoolant (Ethyl Chloride Mist Spray) Nature's Tears Nature's Tears Device: Sterile Water
- Primary Outcome Measures
Name Time Method Pain Scale Using Visual Analog Scale less than 5 minutes following spray application 0-No Pain; 1-3 Mild Pain; 4-6 Moderate-Severe Pain; 7-9 Very Severe Pain;10 Worst Possible Pain
- Secondary Outcome Measures
Name Time Method Satisfaction Scale Using 1-5 Likert Scale less than 5 minutes following spray application 1-Very Satisfied; 2-Somewhat Satisfied; 3-Neither Satisfied or Dissatisfied; 4-Somewhat Satisfied; 5-Very Satisfied
Using the Same Visual Analog Scale Rate Pain the Last Time the Patient Remembers Having an IV Inserted At baseline prior to spray application Visual Analog Scale 0 no pain, 1-2 mild, 3-5 moderate, 6 severe, 7-8 very severe, 9-10 worst possible pain
Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed less than 10 minutes following spray application Yes or No question
Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted At baseline prior to spray application 1-5 Likert Scale
1 very dissatisfied, 2 somewhat dissatisfied, 3 neither satisfied or dissatisfied, 4 somewhat satisfied, 5 very satisfied
Trial Locations
- Locations (1)
Aultman Health Foundation
🇺🇸Canton, Ohio, United States