Aultman Health Foundation
Canton, Ohio, 44710, United States
NCT Number: NCT03054740
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.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 4
Canton, Ohio, 44710, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Sterile water mist will be administered 1-2 sprays prior to intravenous access
Other names: Sterile Water
Time frame: less than 5 minutes following spray application
0-No Pain; 1-3 Mild Pain; 4-6 Moderate-Severe Pain; 7-9 Very Severe Pain;10 Worst Possible Pain
Time frame: less than 5 minutes following spray application
1-Very Satisfied; 2-Somewhat Satisfied; 3-Neither Satisfied or Dissatisfied; 4-Somewhat Satisfied; 5-Very Satisfied
Time frame: At baseline prior to spray application
1-5 Likert Scale
1 very dissatisfied, 2 somewhat dissatisfied, 3 neither satisfied or dissatisfied, 4 somewhat satisfied, 5 very satisfied
Time frame: At baseline prior to spray application
Visual Analog Scale 0 no pain, 1-2 mild, 3-5 moderate, 6 severe, 7-8 very severe, 9-10 worst possible pain
Time frame: less than 10 minutes following spray application
Yes or No question
Aultman Health Foundation
Other
Will Patients Perceive a Vapocoolant Spray to be Effective in Reducing Pain and Increasing Satisfaction With Insertion at an Intravenous Site?
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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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