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Completed

NCT Number: NCT03054740

Vapocoolant Spray Used Prior to Intravenous (IV) Insertions

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aultman Health Foundation

Canton, Ohio, 44710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gebauer Ethyl Chloride

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.

Other names: Ethyl Chloride Mist Spray Can

Nature's Tears

Drug

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

Other names: Sterile Water

Primary outcomes

  1. Pain Scale Using Visual Analog Scale

    Time frame: 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 outcomes

  1. Satisfaction Scale Using 1-5 Likert Scale

    Time frame: less than 5 minutes following spray application

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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: less than 10 minutes following spray application

    Yes or No question

Sponsors and collaborators

Lead sponsor

Aultman Health Foundation

Other

Registry information

Official study title

Will Patients Perceive a Vapocoolant Spray to be Effective in Reducing Pain and Increasing Satisfaction With Insertion at an Intravenous Site?

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 16, 2017
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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