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OpenTrials
Completed

NCT Number: NCT02499965

Skin Refrigerant to Reduce the Pain Associated With IV Insertion

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

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Treatment and study plan

Ethyl Chloride Topical Aerosol Anesthetic

Drug

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

Other names: Study Device or Product B

Nature's Tears Sterile Water

Drug

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

Other names: Placebo or Product A

Primary outcomes

  1. Pain

    Time frame: 1 minute

    Ordinal pain scale (1-10)

Secondary outcomes

  1. Preferred product

    Time frame: 1 minute

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

  2. Desire to use on self in future

    Time frame: 1 minute

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

  3. Desire to use on patients in future

    Time frame: 1 minute

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

  4. Likelihood to use on patients in future

    Time frame: 1 minute

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

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 16, 2015
Registry last updated
Jul 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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