Cryospray to Reduce Pain During Venous Cannulation - Randomized Placebo-controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Patients reported pain from the puncture site
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)