Clinical trial NCT04865783: Cryospray to Reduce Pain During Venous Cannulation
Official title: Cryospray to Reduce Pain During Venous Cannulation - Randomized Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheterization
Anesthetics, Intravenous
Elective Surgical Procedures
Keywords: cryospray
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial aims to evaluate if cryospray can reduce pain during intravenous cannulation in elective surgery compared to a placebo spray.

Detailed description: Venous cannulation is a common practice in the health care system. Before any procedure, intravenous access is always placed before induction of any anaesthesia. For many patients placement of a venous catheter is associated with pain and discomfort. Any quick and easy reduction in pain during the procedure is important for patients. Cryospray has been described as an easy-to-use supplement of analgesia to alleviate pain during intravenous access. Cryospray has been shown to reduce pain in venous cannulation in the emergency setting but not in the elective setting. A search in the literature reveals 2 recent metanalyses reporting 8 included trials and 11 included trials, respectively. Both metanalyses call for further research in relation to patients' satisfaction. By randomizing patients to either cryospray or placebo before venous cannulation, we hypothesize that cryospray reduces pain during venous cannulation compared to placebo.

Eligibility criteria: 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.

Primary outcomes:
measure: Patients reported pain from the puncture site
timeFrame: immediately after completion of vein canulation
Secondary outcomes:
measure: Difficulty in placement of intravenous line
timeFrame: immediately after completion of vein canulation
measure: Number of successful placements of venous line at first attempt
timeFrame: immediately after completion of vein canulation
Other outcomes:
measure: Discomfort from puncture site at discharge from recovery
timeFrame: up to 24 hours after discharge from recovery room
Locations:
city: Aabenraa
country: Denmark
facility: Sygehus Soenderjylland
Study officials:
affiliation: University Hospital of Southern Denmark
name: Thomas Strøm
role: PRINCIPAL_INVESTIGATOR
References:
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.
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: 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.