Cryospray to Reduce Pain During Venous Cannulation

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

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

Study Overview

• Status: Completed
• Conditions: Catheterization; Elective Surgical Procedures; Anesthetics, Intravenous
• Intervention / Treatment: Procedure: Cryospray; Procedure: Saline 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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aabenraa, Denmark, 6200
    • Sygehus Soenderjylland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cryospray; Cryospray will be sprayed from a distance of 20-30 cm to the back of one hand.	Procedure: Cryospray; The cryospray will be applied twice for 1-2 seconds.
Placebo Comparator: Placebo; A saline solution will be sprayed from a distance of 20-30 cm to the back of the hand.	Procedure: Saline spray; The saline spray will be applied twice for 1-2 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Investigators: Principal Investigator: Thomas Strøm, University Hospital of Southern Denmark

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Actual): July 18, 2023
• Study Completion (Actual): July 18, 2023

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: cryospray
• Other Study ID Numbers: SHS-BI-4a-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No