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Completed

NCT Number: NCT04865783

Cryospray to Reduce Pain During Venous Cannulation

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

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Key information

Conditions

Catheterization Anesthetics, Intravenous Elective Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sygehus Soenderjylland

Aabenraa, 6200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

saline spray

Procedure

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

Cryospray

Procedure

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

Primary outcomes

  1. Patients reported pain from the puncture site

    Time frame: 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 outcomes

  1. Difficulty in placement of intravenous line

    Time frame: 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).

  2. Number of successful placements of venous line at first attempt

    Time frame: immediately after completion of vein canulation

    After vein puncture is completed it is indicated wether or not it was successful in first attempt.

Other outcomes

  1. Discomfort from puncture site at discharge from recovery

    Time frame: up to 24 hours after discharge from recovery room

    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).

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2021
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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