PainPhase 4NCT03054740
Vapocoolant Spray Used Prior to Intravenous (IV) Insertions
A Phase 4 study testing Gebauer Ethyl Chloride and Nature's Tears in people with Pain, run by Aultman Health Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Gebauer Ethyl Chloride and Nature's Tears
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2017to 28 Apr 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any outpatient ordered to undergo a Nuclear Medicine Stress Test and is required to have IV access for injection of Radiopharmaceuticals
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Will Patients Perceive a Vapocoolant Spray to be Effective in Reducing Pain and Increasing Satisfaction With Insertion at an Intravenous Site?
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Gebauer Ethyl Chloride, Nature's Tears
- Keywords
- Vapocoolant applied prior to IV access
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gebauer Ethyl ChlorideDrug
Also called Ethyl Chloride Mist Spray Can
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.
Nature's TearsDrug
Also called Sterile Water
Sterile water mist will be administered 1-2 sprays prior to intravenous access
| Study group | Role | What they receive |
|---|---|---|
| Gebauer Ethyl Chloride | Active comparator | Device: Vapocoolant (Ethyl Chloride Mist Spray) Receives: Drug: Gebauer Ethyl Chloride |
| Nature's Tears | Placebo comparator | Device: Sterile Water Receives: Drug: Nature's Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: less than 5 minutes following spray application
Secondary outcomes (4)
Satisfaction Scale Using 1-5 Likert Scale
1-Very Satisfied; 2-Somewhat Satisfied; 3-Neither Satisfied or Dissatisfied; 4-Somewhat Satisfied; 5-Very Satisfied
Measured: 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
1-5 Likert Scale
1 very dissatisfied, 2 somewhat dissatisfied, 3 neither satisfied or dissatisfied, 4 somewhat satisfied, 5 very satisfied
Measured: 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
Measured: At baseline prior to spray application
Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed
Yes or No question
Measured: less than 10 minutes following spray application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start27 Feb 2017
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aultman Health Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitryn Kar, M.D., Principal investigator, Aultman Hospital- Interventional Radiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054740
- Sponsor's protocol ID
- AultmanHF
- Status last verified
- Sep 2018
- First submitted
- 6 Feb 2017
- Last updated
- 3 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27113639Levitt 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.
PubMed 23886287Mace 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.
PubMed 26979261
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Will Patients Perceive a Vapocoolant Spray to be Effective in Reducing Pain and Increasing Satisfaction With Insertion at an Intravenous Site?
- ClinicalTrials.gov ID
- NCT03054740
- Acronym / sponsor ID
- AultmanHF
- Conditions
- Pain
- Keywords
- Vapocoolant applied prior to IV access
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aultman Health FoundationUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Posted 3 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gebauer Ethyl Chloride | Active comparator | Drug: Gebauer Ethyl ChlorideDevice: Vapocoolant (Ethyl Chloride Mist Spray) |
| Nature's Tears | Placebo comparator | Drug: Nature's TearsDevice: Sterile Water |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any outpatient ordered to undergo a Nuclear Medicine Stress Test and is required to have IV access for injection of Radiopharmaceuticals
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gebauer Ethyl ChlorideAlso: Ethyl Chloride Mist Spray CanWill 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. | Drug | Gebauer Ethyl Chloride |
| Nature's TearsAlso: Sterile WaterSterile water mist will be administered 1-2 sprays prior to intravenous access | Drug | Nature's Tears |
Primary outcome
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
4 secondary outcomes
Satisfaction Scale Using 1-5 Likert Scale
Time frame: 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
Time frame: At baseline prior to spray application
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
Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed
Time frame: less than 10 minutes following spray application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27113639Griffith 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.
- Background: PubMed 23886287Levitt 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.
- Background: PubMed 26979261Mace 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitryn Kar, M.D. principal investigator
Aultman Hospital- Interventional Radiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gebauer Ethyl Chloride and Nature's Tears in people with Pain, run by Aultman Health Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scale Using Visual Analog Scale (time frame: less than 5 minutes following spray application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03054740, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.