Catheterization, Anesthetics, Intravenous, Elective Surgical Procedures
Conditions
Keywords
cryospray
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.
Interventions
PROCEDURESaline spray
The saline spray will be applied twice for 1-2 seconds.
PROCEDURECryospray
The cryospray will be applied twice for 1-2 seconds.
Sponsors
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients reported pain from the puncture site | 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
| Measure | Time frame | Description |
|---|---|---|
| Difficulty in placement of intravenous line | 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). |
| Number of successful placements of venous line at first attempt | immediately after completion of vein canulation | After vein puncture is completed it is indicated wether or not it was successful in first attempt. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Discomfort from puncture site at discharge from recovery | 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). |
Countries
Denmark
Outcome results
None listed