Skip to main content
Clinical Trials/NCT04865783
NCT04865783
Completed
N/A

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

University of Southern Denmark1 site in 1 country130 target enrollmentMay 25, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Catheterization
Sponsor
University of Southern Denmark
Enrollment
130
Locations
1
Primary Endpoint
Patients reported pain from the puncture site
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 25, 2021
End Date
July 18, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • 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)

Study Sites (1)

Loading locations...

Similar Trials