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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryospray | Active Comparator | Cryospray will be sprayed from a distance of 20-30 cm to the back of one hand. |
|
| Placebo | Placebo Comparator | A saline solution will be sprayed from a distance of 20-30 cm to the back of the hand. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline spray | Procedure | The saline spray will be applied twice for 1-2 seconds. |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort from puncture site at discharge from recovery | 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). | up to 24 hours after discharge from recovery room |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Strøm | Esbjerg Hospital - University Hospital of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sygehus Soenderjylland | Aabenraa | 6200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26979261 | Background | 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. | |
| 27113639 | Background | 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(4):CD009484. doi: 10.1002/14651858.CD009484.pub2. |
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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
| Cryospray |
| Procedure |
The cryospray will be applied twice for 1-2 seconds. |
|
After vein puncture is completed it is indicated wether or not it was successful in first attempt. |
| immediately after completion of vein canulation |
| 30253890 | Background | 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. |
| 39702029 | Derived | Pedersen JB, Martensen A, Funder P, Bakke SA, Bhavsar RP, Strom T. Cryospray reduces pain during venous cannulation in elective surgery patients: a randomized placebo-controlled study. BMC Anesthesiol. 2024 Dec 19;24(1):466. doi: 10.1186/s12871-024-02858-2. |