Cryospray to Reduce Pain During Venous Cannulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-25

Study Completion Date

2023-07-18

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.

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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.

Conditions

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Catheterization Anesthetics, Intravenous Elective Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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

Study Groups

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Cryospray

Cryospray will be sprayed from a distance of 20-30 cm to the back of one hand.

Group Type ACTIVE_COMPARATOR

Cryospray

Intervention Type PROCEDURE

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

Placebo

A saline solution will be sprayed from a distance of 20-30 cm to the back of the hand.

Group Type PLACEBO_COMPARATOR

Saline spray

Intervention Type PROCEDURE

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

Interventions

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Saline spray

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

Intervention Type PROCEDURE

Cryospray

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

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No