CatheterizationNCT04865783
Cryospray to Reduce Pain During Venous Cannulation
A study testing Saline spray and Cryospray in people with Catheterization and Anesthetics, Intravenous, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
This trial aims to evaluate if cryospray can reduce pain during intravenous cannulation in elective surgery compared to a placebo spray. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization, Anesthetics, Intravenous, Elective Surgical Procedures
- What is being tested?
- Saline spray and Cryospray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- 25 May 2021to 18 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older and able to give consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cryospray to Reduce Pain During Venous Cannulation - Randomized Placebo-controlled Study
This trial aims to evaluate if cryospray can reduce pain during intravenous cannulation in elective surgery compared to a placebo spray.
Read the 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.
- Being tested
- Saline spray, Cryospray
- Keywords
- cryospray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline sprayProcedure or surgery
The saline spray will be applied twice for 1-2 seconds.
CryosprayProcedure or surgery
The cryospray will be applied twice for 1-2 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Cryospray | Active comparator | Cryospray will be sprayed from a distance of 20-30 cm to the back of one hand. Receives: Procedure: Cryospray |
| Placebo | Placebo comparator | A saline solution will be sprayed from a distance of 20-30 cm to the back of the hand. Receives: Procedure: Saline spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: immediately after completion of vein canulation
Secondary outcomes (2)
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).
Measured: 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.
Measured: immediately after completion of vein canulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start25 May 2021
- Primary completion18 Jul 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Strøm, Principal investigator, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865783
- Sponsor's protocol ID
- SHS-BI-4a-2021
- Status last verified
- May 2024
- First submitted
- 28 Apr 2021
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26979261Griffith 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.
PubMed 27113639Zhu 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.
PubMed 30253890Pedersen 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.
PubMed 39702029
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryospray to Reduce Pain During Venous Cannulation - Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04865783
- Acronym / sponsor ID
- SHS-BI-4a-2021
- Keywords
- cryospray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryospray | Active comparator | Procedure: CryosprayCryospray will be sprayed from a distance of 20-30 cm to the back of one hand. |
| Placebo | Placebo comparator | Procedure: Saline sprayA saline solution will be sprayed from a distance of 20-30 cm to the back of the hand. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older and able to give consent
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline sprayThe saline spray will be applied twice for 1-2 seconds. | Procedure or surgery | Placebo |
| CryosprayThe cryospray will be applied twice for 1-2 seconds. | Procedure or surgery | Cryospray |
Primary outcome
Patients reported pain from the puncture site
Time frame: 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)
2 secondary outcomes
Difficulty in placement of intravenous line
Time frame: immediately after completion of vein canulation
Number of successful placements of venous line at first attempt
Time frame: immediately after completion of vein canulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Background: PubMed 26979261Mace 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.
- Background: PubMed 27113639Griffith 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.
- Background: PubMed 30253890Zhu 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.
- Derived from this study: PubMed 39702029Pedersen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Strøm principal investigator
Esbjerg Hospital - University Hospital of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline spray and Cryospray in people with Catheterization and Anesthetics, Intravenous, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients reported pain from the puncture site (time frame: immediately after completion of vein canulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04865783, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024; AzTrials last refreshed its copy on 30 Oct 2026.