Cryospray to Reduce Pain During Venous Cannulation

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

Detailed Description
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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.

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

Conditions
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Catheterization, Anesthetics, Intravenous, Elective Surgical Procedures

Intervention / Treatment
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* Procedure: Saline spray
* Procedure: Cryospray


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryospray