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PainNCT02499965

Skin Refrigerant to Reduce the Pain Associated With IV Insertion

A study testing Ethyl Chloride Topical Aerosol Anesthetic and Nature's Tears Sterile Water in people with Pain, run by Brooke Army Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether or not the pain of IV catheter insertion in the Emergency Department can be reduced significantly with the use of a rapid acting topical anesthetic spray and to determine whether or not healthcare providers who undergo such treatment are likely to endorse its use in… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Ethyl Chloride Topical Aerosol Anesthetic and Nature's Tears Sterile Water
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteUnited States
Study dates
Apr 2015to May 2015
Phase
Interventional
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age
  • A healthcare worker who routinely orders or places IV catheters.
  • Consents to participate in the study.

Who cannot join

  • History of hypersensitivity to Ethyl Chloride.
  • Break, or swollen in the skin at the proposed IV site.
  • Pregnancy or lactating female.
  • Recent tattoo in either of the two proposed anatomical areas for IV cannulation.
  • Skin infection in either of the two proposed anatomical areas for IV cannulation.
  • Missing a contralateral limb to place the second IV.
  • Recent trauma to one of the upper extremities or any neuropathic or radicular condition that could affect the participant's perception of pain in the antecubital fossa of each arm.
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

Other trials in United States

About this study

Official title: The Use of a Topical Anesthetic Skin Refrigerant to Reduce the Pain Associated With Intravenous Catheter Insertion, A Double Blinded, Patient/Placebo Controlled, Study

The purpose of this study is to determine whether or not the pain of IV catheter insertion in the Emergency Department can be reduced significantly with the use of a rapid acting topical anesthetic spray and to determine whether or not healthcare providers who undergo such treatment are likely to endorse its use in their future practice.

Read the detailed description

We recruited 38 emergency department healthcare providers (doctors, physician assistants, nurses and medics) to receive a total of two separate IV canulations - one in one arm and the other in the other. One IV canulation would be pretreated with Ethyl Chloride topical anesthetic (the study product) and the other would be pre-treated with a placebo (sterile water in an aerosol can). Both the participants and the nurses, PAs and medics who placed the IVs were blinded as to which was the Ethyl Chloride and which was the placebo. After the IVs were placed the participants were asked to rate the pain of IV canulation on a scale of 1 to 10 for each of the pre-treatments, to state which one they believed to be superior in reducing the pain of receiving the IV, to state whether or not they would like the intervention that they rated as superior to be used on themselves and finally how likely they were on a 5 point scale to incorporate the intervention they rated as superior into their future practice.

Conditions
Pain
Being tested
Ethyl Chloride Topical Aerosol Anesthetic, Nature's Tears Sterile Water
Keywords
Topical Anesthetic, Ethyl Chloride, Pain Reduction, IV cannulation
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ethyl Chloride Topical Aerosol AnestheticDrug

    Also called Study Device or Product B

    Sprayed on the skin for 5-8 seconds immediately before IV cannulation

  • Nature's Tears Sterile WaterDrug

    Also called Placebo or Product A

    Sprayed on the skin for 5-8 seconds immediately before IV cannulation

Study groups in NCT02499965
Study groupRoleWhat they receive
Topical Ethyl Chloride (Product B)Active comparatorEthyl Chloride Topical Aerosol Anesthetic applied to arm
Receives: Drug: Ethyl Chloride Topical Aerosol Anesthetic
Topical Sterile Water (Product A)Placebo comparatorNature's Tears Sterile water in an aerosol can
Receives: Drug: Nature's Tears Sterile Water

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain

    Ordinal pain scale (1-10)

    Measured: 1 minute

Secondary outcomes (4)

  1. Preferred product

    Categorical selection of preferred product for use on self prior to IV placement

    Measured: 1 minute

  2. Desire to use on self in future

    Binary (yes, no) desire to use on self prior to IV placement in future

    Measured: 1 minute

  3. Desire to use on patients in future

    Binary (yes, no) desire to use on patients prior to IV placement in future

    Measured: 1 minute

  4. Likelihood to use on patients in future

    5 point likert scale ranging from "very unlikely" to "very likely"

    Measured: 1 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02499965
Sponsor's protocol ID
404187-2
Status last verified
Jul 2015
First submitted
14 Jul 2015
Last updated
16 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • Fung S, Phadke CP, Kam A, Ismail F, Boulias C. Effect of topical anesthetics on needle insertion pain during botulinum toxin type A injections for limb spasticity. Arch Phys Med Rehabil. 2012 Sep;93(9):1643-7. doi: 10.1016/j.apmr.2012.03.012. Epub 2012 Mar 23.

    PubMed 22449552

  • Mawhorter S, Daugherty L, Ford A, Hughes R, Metzger D, Easley K. Topical vapocoolant quickly and effectively reduces vaccine-associated pain: results of a randomized, single-blinded, placebo-controlled study. J Travel Med. 2004 Sep-Oct;11(5):267-72. doi: 10.2310/7060.2004.19101.

    PubMed 15544709

  • Hartstein 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 18434455

  • Farion KJ, Splinter KL, Newhook K, Gaboury I, Splinter WM. The effect of vapocoolant spray on pain due to intravenous cannulation in children: a randomized controlled trial. CMAJ. 2008 Jul 1;179(1):31-6. doi: 10.1503/cmaj.070874.

    PubMed 18591524

  • 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 19208703

  • Costello M, Ramundo M, Christopher NC, Powell KR. Ethyl vinyl chloride vapocoolant spray fails to decrease pain associated with intravenous cannulation in children. Clin Pediatr (Phila). 2006 Sep;45(7):628-32. doi: 10.1177/0009922806291013.

    PubMed 16928840

  • Ducharme, J. (2011). Acute Pain Management in Adults. In J. E. Tintinalli, J. S. Stapczynski, O. J. Ma, D. M. Cline, R. K. Cydulka, & G. D. Meckler, Tintinalli

  • Fossum K, Love SL, April MD. Topical ethyl chloride to reduce pain associated with venous catheterization: a randomized crossover trial. Am J Emerg Med. 2016 May;34(5):845-50. doi: 10.1016/j.ajem.2016.01.039. Epub 2016 Feb 13.

    PubMed 26971823

Questions about this trial

What is this clinical trial studying?

A study testing Ethyl Chloride Topical Aerosol Anesthetic and Nature's Tears Sterile Water in people with Pain, run by Brooke Army Medical Center 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 3 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 16 Jul 2015. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (time frame: 1 minute). 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 NCT02499965, 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 16 Jul 2015.

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