Vapocoolant Spray Used Prior to Intravenous (IV) Insertions

Pain Clinical Trial

Official title:

Will Patients Perceive a Vapocoolant Spray to be Effective in Reducing Pain and Increasing Satisfaction With Insertion at an Intravenous Site?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054740
• Other study ID #: AultmanHF
• Status: Completed
• Phase: Phase 4
• Start date: February 27, 2017
• Est. completion date: April 28, 2017

Study information

• Verified date: September 2018
• Source: Aultman Health Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 28, 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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.
• Nature's Tears
Sterile water mist will be administered 1-2 sprays prior to intravenous access

Locations

Country	Name	City	State
United States	Aultman Health Foundation	Canton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Aultman Health Foundation

Country where clinical trial is conducted

United States, 

References & 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:CD009484. doi: 10.1002/14651858.CD009484.pub2. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed	Yes or No question	less than 10 minutes following spray application