Vapocoolant Spray Used Prior to Intravenous (IV) Insertions

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Gebauer Ethyl Chloride; Drug: Nature's Tears

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Health Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Gebauer Ethyl Chloride; Device: Vapocoolant (Ethyl Chloride Mist Spray)	Drug: Gebauer Ethyl Chloride; 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.; Other Names: Ethyl Chloride Mist Spray Can
PLACEBO_COMPARATOR: Nature's Tears; Device: Sterile Water	Drug: Nature's Tears; Sterile water mist will be administered 1-2 sprays prior to intravenous access; Other Names: Sterile Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction Scale Using 1-5 Likert Scale	1-Very Satisfied; 2-Somewhat Satisfied; 3-Neither Satisfied or Dissatisfied; 4-Somewhat Satisfied; 5-Very Satisfied	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	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	At baseline prior to spray application
Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed	Yes or No question	less than 10 minutes following spray application

Collaborators and Investigators

• Sponsor: Aultman Health Foundation
• Investigators: Principal Investigator: Mitryn Kar, M.D., Aultman Hospital- Interventional Radiologist

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 27, 2017
• Primary Completion (ACTUAL): April 28, 2017
• Study Completion (ACTUAL): April 28, 2017

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (ACTUAL): February 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Vapocoolant applied prior to IV access
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ethyl Chloride
• Other Study ID Numbers: AultmanHF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No