Vapocoolant Spray Used Prior to Intravenous (IV) Insertions

NCT03054740 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: AultmanHF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Vapocoolant applied prior to IV access

Outcome Measures

Primary Outcomes (1)

• 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

  less than 5 minutes following spray application

Secondary Outcomes (4)

• Satisfaction Scale Using 1-5 Likert Scale

  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

  At baseline prior to spray application

• Using the Same Visual Analog Scale Rate Pain the Last Time the Patient Remembers Having an IV Inserted

  At baseline prior to spray application

• Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed

  less than 10 minutes following spray application

Study Arms (2)

Gebauer Ethyl Chloride

ACTIVE COMPARATOR

Device: Vapocoolant (Ethyl Chloride Mist Spray)

Drug: Gebauer Ethyl Chloride

Nature's Tears

PLACEBO COMPARATOR

Device: Sterile Water

Drug: Nature's Tears

Interventions

Gebauer Ethyl Chloride DRUG

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.

Also known as: Ethyl Chloride Mist Spray Can

Gebauer Ethyl Chloride

Nature's Tears DRUG

Sterile water mist will be administered 1-2 sprays prior to intravenous access

Also known as: Sterile Water

Nature's Tears

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any outpatient ordered to undergo a Nuclear Medicine Stress Test and is required to have IV access for injection of Radiopharmaceuticals

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aultman Health Foundation: lead

Study Sites (1)

Aultman Health Foundation

Canton, Ohio, 44710, United States

Location

Related Publications (3)

• 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.

  PMID: 27113639 BACKGROUND

• Levitt 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.

  PMID: 23886287 BACKGROUND

• Mace 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.

  PMID: 26979261 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Ethyl Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Jane Sewell
• Organization: Aultman Health Foundation

Jane.Sewell@aultman.com

330 363 0000

Study Officials

• Mitryn Kar, M.D.

  Aultman Hospital- Interventional Radiologist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 16, 2017
• Study Start: February 27, 2017
• Primary Completion: April 28, 2017
• Study Completion: April 28, 2017
• Last Updated: October 3, 2018
• Results First Posted: October 3, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)