Clinical trial NCT03054740: Vapocoolant Spray Used Prior to Intravenous (IV) Insertions
Official title: Will Patients Perceive a Vapocoolant Spray to be Effective in Reducing Pain and Increasing Satisfaction With Insertion at an Intravenous Site?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Vapocoolant applied prior to IV access
Lead sponsor: Aultman Health Foundation
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Scale Using Visual Analog Scale
timeFrame: less than 5 minutes following spray application
Secondary outcomes:
measure: Satisfaction Scale Using 1-5 Likert Scale
timeFrame: less than 5 minutes following spray application
measure: Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted
timeFrame: At baseline prior to spray application
measure: Using the Same Visual Analog Scale Rate Pain the Last Time the Patient Remembers Having an IV Inserted
timeFrame: At baseline prior to spray application
measure: Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed
timeFrame: less than 10 minutes following spray application
Other outcomes:
Locations:
city: Canton
country: United States
facility: Aultman Health Foundation
state: Ohio
Study officials:
affiliation: Aultman Hospital- Interventional Radiologist
name: Mitryn Kar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.