Catheterization Clinical Trial
Official title:
Cryospray to Reduce Pain During Venous Cannulation - Randomized Placebo-controlled Study
Verified date | May 2024 |
Source | University of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial aims to evaluate if cryospray can reduce pain during intravenous cannulation in elective surgery compared to a placebo spray.
Status | Completed |
Enrollment | 130 |
Est. completion date | July 18, 2023 |
Est. primary completion date | July 18, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years or older and able to give consent Exclusion Criteria: - Unable to give consent - Infection - coloring or bruises at the puncture site (use of corticosteroid etc). - No vein signs visible after application of vein stasis. - Allergy to coolant spray. - Contraindication for vein stasis or vein cannulation (ex Raynauds disease etc). - Has participated earlier in the trial. |
Country | Name | City | State |
---|---|---|---|
Denmark | Sygehus Soenderjylland | Aabenraa |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark |
Denmark,
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. — 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
Zhu Y, Peng X, Wang S, Chen W, Liu C, Guo B, Zhao L, Gao Y, Wang K, Lou F. Vapocoolant spray versus placebo spray/no treatment for reducing pain from intravenous cannulation: A meta-analysis of randomized controlled trials. Am J Emerg Med. 2018 Nov;36(11):2085-2092. doi: 10.1016/j.ajem.2018.03.068. Epub 2018 Mar 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Discomfort from puncture site at discharge from recovery | After discharge from the recovery room patients is asked for any discomfort at the puncture site. If yes: pain, numbness, burning or cold feeling. All positive values rated on the numeric rating scale (0-10). | up to 24 hours after discharge from recovery room | |
Primary | Patients reported pain from the puncture site | After vein puncture is completed patients is asked on a scale from 0-10 to indicate pain during vein canulation (zero no pain, 10 worst possible pain) | immediately after completion of vein canulation | |
Secondary | Difficulty in placement of intravenous line | After vein puncture is completed the operator is asked to the difficulty in placement of the venous line (0-10, zero very easy and ten very difficult). | immediately after completion of vein canulation | |
Secondary | Number of successful placements of venous line at first attempt | After vein puncture is completed it is indicated wether or not it was successful in first attempt. | immediately after completion of vein canulation |
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