PainNCT01670487
Vapocoolant (Pain Ease Medium Stream) for Intravenous Lines in Emergency Department Patients
A study testing Vapocoolant and Sterile water in people with Pain, run by The Cleveland Clinic at 1 site in United States.
Trial summary
To determine the efficacy and safety of vapocoolant stream (Pain Ease Medium Stream ) in decreasing the pain of intravenous cannulation. To compare vapocoolant stream (Pain Ease medium Stream) with control (e.g. sterile water) stream. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Vapocoolant and Sterile water
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2014
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients needing intravenous cannulation
- Adults age 18 years equal or greater than.
- Stable patient
- Mentally competent patient able to understand the consent form
Who cannot join
- Patients with any allergies to the spray components ( e.g.1,1,3,3, pentafluoropropane or 1,1,1,2 tetrafluoroethane )
- Critically ill or unstable patient (e.g. sepsis or shock)
- Infants and children of age , <18 years.
- Pregnant
- Intravenous cannulation site located in area of compromised blood supply. (ex: patients with Peripheral Vascular Disease , Raynaud's disease, gangrene, Buerger's disease)
- Intravenous cannulation site located in area of insensitive skin; such as , patients with a peripheral neuropathy including diabetic neuropathy.
- Patient intolerant of cold or with hypersensitivity to the cold.
- Patient unable or unwilling to give consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective,Randomized,Blinded, Comparative,Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Intravenous Cannulation in Emergency Department Patients.
To determine the efficacy and safety of vapocoolant stream (Pain Ease Medium Stream ) in decreasing the pain of intravenous cannulation.
To compare vapocoolant stream (Pain Ease medium Stream) with control (e.g. sterile water) stream.
Read the detailed description
Vapocoolant sprays have been used to decrease the pain associated with painful medical procedures such as immunizations, needle aspirations, injections, venipuncture and intravenous cannulation. In general, vapocoolant sprays , have been found to be effective in decreasing the pain of various medical procedures. Moreover, the use of vapocoolant sprays ,unlike other local anesthetics , such as infiltrative lidocaine , is not associated with a painful injection and does affect the success rate of the procedure including intravenous cannulation and may even increase the success rate of the intravenous cannulation.
- Conditions
- Pain
- Being tested
- Vapocoolant, Sterile water
- Keywords
- Vapocoolant
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VapocoolantDevice
Also called Pain Ease stream
Topical stream of 4 to 10 seconds duration to skin
Sterile waterDevice
Also called Nature's Tears by Bio-Logic Aqua Technologies
Topical intervention of sterile water stream 4 to 10 seconds to skin.
| Study group | Role | What they receive |
|---|---|---|
| Vapocoolant (Pain Ease Medium Stream) | Active comparator | Application of the stream steadily 4 to 10 seconds onto the cannulation site. |
| Nature's Tears | Placebo comparator | Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site. Receives: Device: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score on the Numeric Rating Scale (NRS)
Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.
Measured: pain of intravenous catheter placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2014
- Study completionDec 2014
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 (8)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Gebauer Company
- Responsible party
- Principal investigator, Sharon Mace, The Cleveland Clinic
- Investigators
- Sharon E. Mace, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670487
- Sponsor's protocol ID
- GEB-02
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2012
- Last updated
- 27 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hijazi R, Taylor D, Richardson J. Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial. BMJ. 2009 Feb 10;338:b215. doi: 10.1136/bmj.b215.
PubMed 19208703Page DE, Taylor DM. Vapocoolant spray vs subcutaneous lidocaine injection for reducing the pain of intravenous cannulation: a randomized, controlled, clinical trial. Br J Anaesth. 2010 Oct;105(4):519-25. doi: 10.1093/bja/aeq198. Epub 2010 Aug 3.
PubMed 20682573Biro P, Meier T, Cummins AS. Comparison of topical anaesthesia methods for venous cannulation in adults. Eur J Pain. 1997;1(1):37-42. doi: 10.1016/s1090-3801(97)90051-3.
PubMed 15102427Hartstein BH, Barry JD. Mitigation of pain during intravenous catheter placement using a topical skin coolant in the emergency department. Emerg Med J. 2008 May;25(5):257-61. doi: 10.1136/emj.2006.044776.
PubMed 18434455Baxter AL, Leong T, Mathew B. External thermomechanical stimulation versus vapocoolant for adult venipuncture pain: pilot data on a novel device. Clin J Pain. 2009 Oct;25(8):705-10. doi: 10.1097/AJP.0b013e3181af1236.
PubMed 19920721Patterson P, Hussa AA, Fedele KA, Vegh GL, Hackman CM. Comparison of 4 analgesic agents for venipuncture. AANA J. 2000 Feb;68(1):43-51.
PubMed 10876451Barbour T, O'Keefe S, Mace SE. Topical Refrigerant Spray for IVs: Patient/Provider Responses - Prospective, Double-blind, Randomized Study. West J Nurs Res. 2021 Aug;43(8):762-769. doi: 10.1177/0193945920976061. Epub 2020 Dec 8.
PubMed 33292081Mace SE. Prospective, double blind, randomized, controlled trial comparing vapocoolant spray versus placebo spray in adults undergoing intravenous cannulation. Scand J Pain. 2017 Oct;17:8-15. doi: 10.1016/j.sjpain.2017.06.002. Epub 2017 Jul 10.
PubMed 28850378
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective,Randomized,Blinded, Comparative,Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Intravenous Cannulation in Emergency Department Patients.
- ClinicalTrials.gov ID
- NCT01670487
- Acronym / sponsor ID
- GEB-02
- Conditions
- Pain
- Keywords
- Vapocoolant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Gebauer Company
- Study start
- Oct 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Posted 21 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy and safety of vapocoolant stream (Pain Ease Medium Stream ) in decreasing the pain of intravenous cannulation.
To compare vapocoolant stream (Pain Ease medium Stream) with control (e.g. sterile water) stream.
Detailed description
Vapocoolant sprays have been used to decrease the pain associated with painful medical procedures such as immunizations, needle aspirations, injections, venipuncture and intravenous cannulation. In general, vapocoolant sprays , have been found to be effective in decreasing the pain of various medical procedures. Moreover, the use of vapocoolant sprays ,unlike other local anesthetics , such as infiltrative lidocaine , is not associated with a painful injection and does affect the success rate of the procedure including intravenous cannulation and may even increase the success rate of the intravenous cannulation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vapocoolant (Pain Ease Medium Stream) | Active comparator | –Application of the stream steadily 4 to 10 seconds onto the cannulation site. |
| Nature's Tears | Placebo comparator | Device: Sterile waterApply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients needing intravenous cannulation
- Adults age 18 years equal or greater than.
- Stable patient
- Mentally competent patient able to understand the consent form
Key exclusion criteria (8 listed)
- Patients with any allergies to the spray components ( e.g.1,1,3,3, pentafluoropropane or 1,1,1,2 tetrafluoroethane )
- Critically ill or unstable patient (e.g. sepsis or shock)
- Infants and children of age , <18 years.
- Pregnant
- Intravenous cannulation site located in area of compromised blood supply. (ex: patients with Peripheral Vascular Disease , Raynaud's disease, gangrene, Buerger's disease)
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 |
|---|---|---|
| VapocoolantAlso: Pain Ease streamTopical stream of 4 to 10 seconds duration to skin | Device | – |
| Sterile waterAlso: Nature's Tears by Bio-Logic Aqua TechnologiesTopical intervention of sterile water stream 4 to 10 seconds to skin. | Device | Nature's Tears |
Primary outcome
Pain Score on the Numeric Rating Scale (NRS)
Time frame: pain of intravenous catheter placement.
Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19208703Hijazi R, Taylor D, Richardson J. Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial. BMJ. 2009 Feb 10;338:b215. doi: 10.1136/bmj.b215.
- Background: PubMed 20682573Page DE, Taylor DM. Vapocoolant spray vs subcutaneous lidocaine injection for reducing the pain of intravenous cannulation: a randomized, controlled, clinical trial. Br J Anaesth. 2010 Oct;105(4):519-25. doi: 10.1093/bja/aeq198. Epub 2010 Aug 3.
- Background: PubMed 15102427Biro P, Meier T, Cummins AS. Comparison of topical anaesthesia methods for venous cannulation in adults. Eur J Pain. 1997;1(1):37-42. doi: 10.1016/s1090-3801(97)90051-3.
- Background: PubMed 18434455Hartstein BH, Barry JD. Mitigation of pain during intravenous catheter placement using a topical skin coolant in the emergency department. Emerg Med J. 2008 May;25(5):257-61. doi: 10.1136/emj.2006.044776.
- Background: PubMed 19920721Baxter AL, Leong T, Mathew B. External thermomechanical stimulation versus vapocoolant for adult venipuncture pain: pilot data on a novel device. Clin J Pain. 2009 Oct;25(8):705-10. doi: 10.1097/AJP.0b013e3181af1236.
- Background: PubMed 10876451Patterson P, Hussa AA, Fedele KA, Vegh GL, Hackman CM. Comparison of 4 analgesic agents for venipuncture. AANA J. 2000 Feb;68(1):43-51.
- Derived from this study: PubMed 33292081Barbour T, O'Keefe S, Mace SE. Topical Refrigerant Spray for IVs: Patient/Provider Responses - Prospective, Double-blind, Randomized Study. West J Nurs Res. 2021 Aug;43(8):762-769. doi: 10.1177/0193945920976061. Epub 2020 Dec 8.
- Derived from this study: PubMed 28850378Mace SE. Prospective, double blind, randomized, controlled trial comparing vapocoolant spray versus placebo spray in adults undergoing intravenous cannulation. Scand J Pain. 2017 Oct;17:8-15. doi: 10.1016/j.sjpain.2017.06.002. Epub 2017 Jul 10.
- 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.
Sharon E. Mace, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vapocoolant and Sterile water in people with Pain, run by The Cleveland Clinic 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 4 inclusion and 8 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 27 Oct 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2016). 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 Score on the Numeric Rating Scale (NRS) (time frame: pain of intravenous catheter placement.). 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 NCT01670487, which also lists 8 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 27 Oct 2025; AzTrials last refreshed its copy on 1 Nov 2026.