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Vapocoolant Spray Used Prior to Intravenous (IV) Insertions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054740
Recruitment Status : Completed
First Posted : February 16, 2017
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Gebauer Ethyl Chloride Drug: Nature's Tears Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Will Patients Perceive a Vapocoolant Spray to be Effective in Reducing Pain and Increasing Satisfaction With Insertion at an Intravenous Site?
Actual Study Start Date : February 27, 2017
Actual Primary Completion Date : April 28, 2017
Actual Study Completion Date : April 28, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

Arm Intervention/treatment
Active Comparator: Gebauer Ethyl Chloride
Device: Vapocoolant (Ethyl Chloride Mist Spray)
Drug: Gebauer Ethyl Chloride
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 Name: Ethyl Chloride Mist Spray Can

Placebo Comparator: Nature's Tears
Device: Sterile Water
Drug: Nature's Tears
Sterile water mist will be administered 1-2 sprays prior to intravenous access
Other Name: Sterile Water




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054740


Locations
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United States, Ohio
Aultman Health Foundation
Canton, Ohio, United States, 44710
Sponsors and Collaborators
Aultman Health Foundation
Investigators
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Principal Investigator: Mitryn Kar, M.D. Aultman Hospital- Interventional Radiologist
  Study Documents (Full-Text)

Documents provided by Aultman Health Foundation:
Publications:
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Responsible Party: Aultman Health Foundation
ClinicalTrials.gov Identifier: NCT03054740    
Other Study ID Numbers: AultmanHF
First Posted: February 16, 2017    Key Record Dates
Results First Posted: October 3, 2018
Last Update Posted: October 3, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aultman Health Foundation:
Vapocoolant applied prior to IV access
Additional relevant MeSH terms:
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Ethyl Chloride
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents