Cryospray to Reduce Pain During Venous Cannulation

Not Applicable

Completed

• Conditions: Elective Surgical Procedures; Catheterization; Anesthetics, Intravenous
• Interventions: Procedure: Cryospray; Procedure: Saline spray

• Registration Number: NCT04865783
• Lead Sponsor: University of Southern Denmark

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.

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-04-29
• Study Start: 2021-05-25
• Primary Completion: 2023-07-18
• Study Completion: 2023-07-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryospray	Cryospray	Cryospray will be sprayed from a distance of 20-30 cm to the back of one hand.
Placebo	Saline spray	A saline solution will be sprayed from a distance of 20-30 cm to the back of the hand.

Primary Outcome Measures

Name	Time	Method
Patients reported pain from the puncture site	immediately after completion of vein canulation	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)

Secondary Outcome Measures

Name	Time	Method
Difficulty in placement of intravenous line	immediately after completion of vein canulation	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).
Number of successful placements of venous line at first attempt	immediately after completion of vein canulation	After vein puncture is completed it is indicated wether or not it was successful in first attempt.

Trial Locations

Locations (1)

Sygehus Soenderjylland; 🇩🇰 Aabenraa, Denmark