Cryospray to Reduce Pain During Venous Cannulation

Catheterization Clinical Trial

Official title:

Cryospray to Reduce Pain During Venous Cannulation - Randomized Placebo-controlled Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04865783
• Other study ID #: SHS-BI-4a-2021
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2023
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 130
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 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.

Related Conditions & MeSH terms

• Anesthetics, Intravenous
• Catheterization
• Elective Surgical Procedures

Intervention

Procedure:
• Saline spray
The saline spray will be applied twice for 1-2 seconds.
• Cryospray
The cryospray will be applied twice for 1-2 seconds.

Locations

Country	Name	City	State
Denmark	Sygehus Soenderjylland	Aabenraa

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

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(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

Outcome

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