Cryospray to Reduce Pain During Venous Cannulation
Study Details
Study Description
Brief Summary
This trial aims to evaluate if cryospray can reduce pain during intravenous cannulation in elective surgery compared to a placebo spray.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Cryospray Cryospray will be sprayed from a distance of 20-30 cm to the back of one hand. |
Procedure: Cryospray
The cryospray will be applied twice for 1-2 seconds.
|
| Placebo Comparator: Placebo A saline solution will be sprayed from a distance of 20-30 cm to the back of the hand. |
Procedure: Saline spray
The saline spray will be applied twice for 1-2 seconds.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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).
Eligibility Criteria
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).
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No vein signs visible after application of vein stasis.
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Allergy to coolant spray.
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Contraindication for vein stasis or vein cannulation (ex Raynauds disease etc).
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Has participated earlier in the trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sygehus Soenderjylland | Aabenraa | Denmark | 6200 |
Sponsors and Collaborators
- University of Southern Denmark
Investigators
- Principal Investigator: Thomas Strøm, University Hospital of Southern Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
- Griffith RJ, Jordan V, Herd D, Reed PW, Dalziel SR. Vapocoolants (cold spray) for pain treatment during intravenous cannulation. Cochrane Database Syst Rev. 2016 Apr 26;4:CD009484. doi: 10.1002/14651858.CD009484.pub2. Review.
- Mace SE. Prospective, randomized, double-blind controlled trial comparing vapocoolant spray vs placebo spray in adults undergoing venipuncture. Am J Emerg Med. 2016 May;34(5):798-804. doi: 10.1016/j.ajem.2016.01.002. Epub 2016 Jan 7.
- Zhu Y, Peng X, Wang S, Chen W, Liu C, Guo B, Zhao L, Gao Y, Wang K, Lou F. Vapocoolant spray versus placebo spray/no treatment for reducing pain from intravenous cannulation: A meta-analysis of randomized controlled trials. Am J Emerg Med. 2018 Nov;36(11):2085-2092. doi: 10.1016/j.ajem.2018.03.068. Epub 2018 Mar 27. Review.
- SHS-BI-4a-2021