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Vapocoolant Spray Used Prior to Intravenous (IV) Insertions

Phase 4
Completed
Conditions
Pain
Interventions
Drug: Gebauer Ethyl Chloride
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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Gebauer Ethyl ChlorideGebauer Ethyl ChlorideDevice: Vapocoolant (Ethyl Chloride Mist Spray)
Nature's TearsNature's TearsDevice: Sterile Water
Primary Outcome Measures
NameTimeMethod
Pain Scale Using Visual Analog Scaleless 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
NameTimeMethod
Satisfaction Scale Using 1-5 Likert Scaleless 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 InsertedAt 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 Neededless 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 InsertedAt 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

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