Pain
Conditions
Keywords
Vapocoolant applied prior to IV access
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.
Interventions
DRUGGebauer 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.
DRUGNature's Tears
Sterile water mist will be administered 1-2 sprays prior to intravenous access
Sponsors
Aultman Health Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Nature's Tears Device: Sterile Water
Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Total | Gebauer Ethyl Chloride | Nature's Tears |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 3 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 12 Participants | 8 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 15 Participants | 7 Participants | 8 Participants |
| Sex: Female, Male Male | 15 Participants | 8 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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
Time frame: less than 5 minutes following spray application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gebauer Ethyl Chloride | Pain Scale Using Visual Analog Scale | 1.13 score on a scale | Standard Deviation 1.302 |
| Nature's Tears | Pain Scale Using Visual Analog Scale | 1.60 score on a scale | Standard Deviation 1.639 |
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
Time frame: less than 5 minutes following spray application
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gebauer Ethyl Chloride | Satisfaction Scale Using 1-5 Likert Scale | Somewhat Satisfied | 2 Participants |
| Gebauer Ethyl Chloride | Satisfaction Scale Using 1-5 Likert Scale | Very Satisified | 13 Participants |
| Nature's Tears | Satisfaction Scale Using 1-5 Likert Scale | Somewhat Satisfied | 5 Participants |
| Nature's Tears | Satisfaction Scale Using 1-5 Likert Scale | Very Satisified | 10 Participants |
p-value: 0.39Fisher Exact
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
Time frame: At baseline prior to spray application
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gebauer Ethyl Chloride | Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted | Somewhat Dissatisfied | 2 Participants |
| Gebauer Ethyl Chloride | Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted | Somewhat Satisfied | 10 Participants |
| Gebauer Ethyl Chloride | Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted | Neither Satisified or Dissatisfied | 0 Participants |
| Gebauer Ethyl Chloride | Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted | Very Satisfied | 2 Participants |
| Gebauer Ethyl Chloride | Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted | Very Dissatisified | 1 Participants |
| Nature's Tears | Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted | Very Satisfied | 1 Participants |
| Nature's Tears | Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted | Very Dissatisified | 0 Participants |
| Nature's Tears | Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted | Somewhat Dissatisfied | 1 Participants |
| Nature's Tears | Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted | Neither Satisified or Dissatisfied | 1 Participants |
| Nature's Tears | Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted | Somewhat Satisfied | 12 Participants |
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
Time frame: At baseline prior to spray application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gebauer Ethyl Chloride | Using the Same Visual Analog Scale Rate Pain the Last Time the Patient Remembers Having an IV Inserted | 3.40 score on a scale | Standard Deviation 2.746 |
| Nature's Tears | Using the Same Visual Analog Scale Rate Pain the Last Time the Patient Remembers Having an IV Inserted | 2.87 score on a scale | Standard Deviation 2.031 |
Secondary
Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed
Yes or No question
Time frame: less than 10 minutes following spray application
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gebauer Ethyl Chloride | Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed | Yes | 12 Participants |
| Gebauer Ethyl Chloride | Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed | No | 3 Participants |
| Nature's Tears | Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed | Yes | 8 Participants |
| Nature's Tears | Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed | No | 7 Participants |