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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gebauer Ethyl Chloride | Active Comparator | Device: Vapocoolant (Ethyl Chloride Mist Spray) |
|
| Nature's Tears | Placebo Comparator | Device: Sterile Water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | less than 5 minutes following spray application |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction Scale Using 1-5 Likert Scale | 1-Very Satisfied; 2-Somewhat Satisfied; 3-Neither Satisfied or Dissatisfied; 4-Somewhat Satisfied; 5-Very Satisfied | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitryn Kar, M.D. | Aultman Hospital- Interventional Radiologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aultman Health Foundation | Canton | Ohio | 44710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27113639 | Background | Griffith RJ, Jordan V, Herd D, Reed PW, Dalziel SR. Vapocoolants (cold spray) for pain treatment during intravenous cannulation. Cochrane Database Syst Rev. 2016 Apr 26;4(4):CD009484. doi: 10.1002/14651858.CD009484.pub2. | |
| 23886287 | Background | Levitt FC, Ziemba-Davis M. An exploratory study of patient preferences for pain management during intravenous insertion: maybe we should sweat the small stuff. J Perianesth Nurs. 2013 Aug;28(4):223-32. doi: 10.1016/j.jopan.2012.11.008. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gebauer Ethyl Chloride | Device: Vapocoolant (Ethyl Chloride Mist Spray) 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. |
| FG001 | Nature's Tears | Device: Sterile Water Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gebauer Ethyl Chloride | Device: Vapocoolant (Ethyl Chloride Mist Spray) 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | less than 5 minutes following spray application |
|
2 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gebauer Ethyl Chloride | Drug: Vapocoolant (Ethyl Chloride Mist Spray) 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Sewell | Aultman Health Foundation | 330 363 0000 | 3334 | Jane.Sewell@aultman.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2017 | Feb 14, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005018 | Ethyl Chloride |
| ID | Term |
|---|---|
| D006843 | Hydrocarbons, Chlorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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|
| Nature's Tears | Drug | Sterile water mist will be administered 1-2 sprays prior to intravenous access |
|
|
1-5 Likert Scale 1 very dissatisfied, 2 somewhat dissatisfied, 3 neither satisfied or dissatisfied, 4 somewhat satisfied, 5 very satisfied |
| 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 | At baseline prior to spray application |
| Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed | Yes or No question | less than 10 minutes following spray application |
| 26979261 | Background | Mace SE. Prospective, randomized, double-blind controlled trial comparing vapocoolant spray vs placebo spray in adults undergoing venipuncture. Am J Emerg Med. 2016 May;34(5):798-804. doi: 10.1016/j.ajem.2016.01.002. Epub 2016 Jan 7. |
| Nature's Tears |
Device: Sterile Water Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
|
| Secondary | Satisfaction Scale Using 1-5 Likert Scale | 1-Very Satisfied; 2-Somewhat Satisfied; 3-Neither Satisfied or Dissatisfied; 4-Somewhat Satisfied; 5-Very Satisfied | Posted | Count of Participants | Participants | less than 5 minutes following spray application |
|
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | At baseline prior to spray application |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | At baseline prior to spray application |
|
|
|
| Secondary | Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed | Yes or No question | Posted | Count of Participants | Participants | less than 10 minutes following spray application |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Nature's Tears | Drug: Sterile Water Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access | 0 | 15 | 0 | 15 | 0 | 15 |
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| Neither Satisified or Dissatisfied |
|
| Somewhat Satisfied |
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| Very Satisfied |
|