Cryospray to Reduce Pain During Venous Cannulation

NCT04865783 | Completed

• 1 other identifier: SHS-BI-4a-2021
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Catheterization; Anesthetics, Intravenous; Elective Surgical Procedures

Keywords

cryospray

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Difficulty in placement of intravenous line

  immediately after completion of vein canulation

• Number of successful placements of venous line at first attempt

  immediately after completion of vein canulation

Other Outcomes (1)

• Discomfort from puncture site at discharge from recovery

  up to 24 hours after discharge from recovery room

Study Arms (2)

Cryospray

ACTIVE COMPARATOR

Cryospray will be sprayed from a distance of 20-30 cm to the back of one hand.

Procedure: Cryospray

Placebo

PLACEBO COMPARATOR

A saline solution will be sprayed from a distance of 20-30 cm to the back of the hand.

Procedure: Saline spray

Interventions

Saline spray PROCEDURE

The saline spray will be applied twice for 1-2 seconds.

Placebo

Cryospray PROCEDURE

The cryospray will be applied twice for 1-2 seconds.

Cryospray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older and able to give consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Sygehus Soenderjylland

Aabenraa, 6200, Denmark

Location

Related Publications (4)

• 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.

  PMID: 26979261 BACKGROUND

• 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.

  PMID: 27113639 BACKGROUND

• 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.

  PMID: 30253890 BACKGROUND

• Pedersen JB, Martensen A, Funder P, Bakke SA, Bhavsar RP, Strom T. Cryospray reduces pain during venous cannulation in elective surgery patients: a randomized placebo-controlled study. BMC Anesthesiol. 2024 Dec 19;24(1):466. doi: 10.1186/s12871-024-02858-2.

  PMID: 39702029 DERIVED

Study Officials

• Thomas Strøm

  University Hospital of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Before elective surgery, all patients will have an intravenous line placed before induction of anaesthesia. Patients will be blinded to whether cryospray or placebo is used. Two anaesthesia trained persons (nurse/doctors) will perform the procedure. One person will randomize and apply the randomized spray and the other person will be blinded to the randomized treatment. The anesthesiologist performing the puncture but blinded for randomization will fill out a questionnaire
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: April 29, 2021
• Study Start: May 25, 2021
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)