Visual Analog Pain ScaleNCT06789055
Vapocoolant Spray's Role in Reducing Pain During Capillary Glucose Testing
A study testing Vapocoolant Spray in people with Visual Analog Pain Scale, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Capillary blood glucose measurement is a routine procedure in emergency departments, but it may cause pain and discomfort because it requires fingertip puncture. Vapocoolant spray is a rapid, noninvasive, and inexpensive method of topical analgesia that may reduce pain during minor procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visual Analog Pain Scale
- What is being tested?
- Vapocoolant Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 14 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients aged ≥18 years
- Patients requiring at least two capillary blood glucose measurements for any reason
- Patients who agree to participate in the study
Who cannot join
- Allergy to the components of the spray
- Conditions that may affect capillary blood glucose measurement or pain perception, such as peripheral neuropathy or peripheral arterial disease
- Blood glucose levels outside the measurable range of the capillary device (extremely low or high levels)
- Cognitive disorders that prevent the evaluation of the Visual Analog Scale (VAS), such as dementia, Alzheimer's disease, or cerebrovascular diseases
- Severe conditions in other parts of the body that may interfere with pain evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Vapocoolant Spray in Reducing Pain During Capillary Glucose Testing: A Randomized Crossover Trial
Capillary blood glucose measurement is a routine procedure in emergency departments, but it may cause pain and discomfort because it requires fingertip puncture. Vapocoolant spray is a rapid, noninvasive, and inexpensive method of topical analgesia that may reduce pain during minor procedures. However, its effectiveness during capillary blood glucose testing has not been sufficiently studied. This study aims to evaluate whether vapocoolant spray reduces pain during capillary blood glucose measurement compared with placebo in adult emergency department patients requiring at least two clinically indicated glucose measurements. In this randomized, placebo-controlled crossover trial, participants receive both vapocoolant spray and placebo in a randomized sequence before two separate capillary glucose measurements. Pain is assessed immediately after each procedure using a 100 mm Visual Analog Scale. The findings may help inform practical strategies to improve patient comfort during routine glucose testing in emergency care settings.
Read the detailed description
This study is a single-center, randomized, placebo-controlled crossover trial conducted in the emergency department of a tertiary care hospital. The study evaluates the efficacy of vapocoolant spray in reducing pain during capillary blood glucose measurement in adult patients who require at least two clinically indicated capillary glucose measurements during the same emergency department visit.
Capillary blood glucose testing is frequently performed in emergency care and is essential for the evaluation and management of many patients. Although it is considered a minor procedure, repeated fingertip punctures may cause pain, discomfort, and procedure-related distress. Vapocoolant spray produces rapid skin cooling and may provide short-term cutaneous analgesia through temporary reduction of sensory nerve conduction. While vapocoolants have been studied in other needle-related procedures, evidence for their use during capillary blood glucose testing remains limited.
Eligible participants are adults aged 18 years or older who require at least two capillary blood glucose measurements for any clinical indication and who provide informed consent. Participants are randomized to one of two intervention sequences. In one sequence, placebo spray is applied before the first capillary blood glucose measurement and vapocoolant spray is applied before the second measurement. In the other sequence, vapocoolant spray is applied before the first measurement and placebo spray is applied before the second. The second measurement is performed on the corresponding finger of the contralateral hand according to the assigned sequence. No additional punctures beyond those clinically indicated are performed.
Vapocoolant spray containing ethyl chloride is applied from a distance of 30 cm for 10 seconds before the procedure. The placebo consists of sterile water spray applied in the same manner. After spray application, the site is cleansed according to the standard protocol, the fingertip is punctured with a standard lancet, and capillary blood glucose measurement is performed using the study device.
The primary outcome is pain intensity during capillary blood glucose measurement, assessed immediately after each procedure using a 100 mm Visual Analog Scale. Secondary outcomes include adverse events related to spray application, such as pruritus, coolness, numbness, erythema, or burning sensation.
The crossover design allows each participant to serve as their own control, thereby reducing interindividual variability in pain perception. Randomization of intervention order is used to minimize potential sequence and acclimatization effects associated with repeated glucose measurements. The results of this study may support the use of a simple and practical analgesic strategy to improve patient comfort during routine capillary blood glucose testing in emergency department practice.
- Conditions
- Visual Analog Pain Scale
- Being tested
- Vapocoolant Spray, Placebo
- Keywords
- Vapocoolant Spray, Capillary Glucose Testing, Pain Management, Patient Comfort
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vapocoolant SprayOther
Before the capillary blood glucose measurement, vapocoolant spray will be applied to the measurement site from a distance of 30 cm for 10 seconds. Following this, the area will be cleansed with an antimicrobial swab for 10 seconds using a circular motion, starting from the center and moving outward. Subsequently, the fingertip will be punctured with a lancet to obtain a blood sample. The first drop of blood will be wiped away with cotton, and the glucose measurement will be performed using the subsequent drop utilizing the Standard GlucoNavii GDH device. The patient will then be asked to assess their pain during the procedure using the Visual Analog Scale (VAS) for pain evaluation.
PlaceboOther
Before the capillary blood glucose measurement, placebo will be applied to the measurement site from a distance of 30 cm for 10 seconds. Following this, the area will be cleansed with an antimicrobial swab for 10 seconds using a circular motion, starting from the center and moving outward. Subsequently, the fingertip will be punctured with a lancet to obtain a blood sample. The first drop of blood will be wiped away with cotton, and the glucose measurement will be performed using the subsequent drop utilizing the Standard GlucoNavii GDH device. The patient will then be asked to assess their pain during the procedure using the Visual Analog Scale (VAS) for pain evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Placebo, Then Vapocoolant Spray | Other | In the first group, placebo will be applied prior to the initial capillary blood glucose measurement, after which the measurement will be performed, and the patient's pain level will be assessed using the Visual Analog Scale (VAS). For the subsequent second measurement, Vapocoolant spray will be applied before the procedure, followed by the glucose measurement, which will be conducted on the same finger of the opposite hand as used in the first measurement. The patient's pain level will again be evaluated using the VAS. This sequential approach allows for a direct comparison of pain scores between placebo and Vapocoolant spray applications within the same patient. Receives: Other: Vapocoolant Spray; Other: Placebo |
| Vapocoolant Spray, Then Placebo | Other | In the second group, Vapocoolant spray will be applied prior to the initial capillary blood glucose measurement, after which the measurement will be performed, and the patient's pain level will be assessed using the Visual Analog Scale (VAS). For the subsequent second measurement, placebo will be applied before the procedure, followed by the glucose measurement, which will be conducted on the same finger of the opposite hand as used in the first measurement.. This sequential approach allows for a direct comparison of pain scores between placebo and Vapocoolant spray applications within the same patient. Receives: Other: Vapocoolant Spray; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Scale
The primary outcome of this study is the Visual Analog Scale (VAS) score for pain. The VAS is a widely used assessment tool to evaluate variables across a continuum, such as acute pain severity. For the purpose of this study, patients will be presented with a 100-mm line, where one end is labeled "no pain" and the other end is labeled "severe pain." The scale ranges from 0 to 100, with 0 corresponding to no pain and 100 corresponding to severe pain. After each capillary blood glucose measurement, patients will be asked to mark their level of pain on the VAS line based on their experience during the procedure. The VAS score will be determined by measuring the distance in millimeters from the "no pain" end to the point marked by the patient. Higher scores indicate greater pain and therefore a worse outcome. This standardized and validated method provides a quantitative measure of pain that is both simple and reliable for clinical use.
Measured: Immediately after blood glucose measurement, assessed within the first 5 minutes after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start10 Mar 2025
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visual Analog Pain ScaleStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study was designed as a randomized crossover trial. Patients requiring at least two capillary blood glucose measurements were included in the study. Participants were randomized into two groups. In the first group, placebo was applied during the first measurement, and vapocoolant spray was used for the second measurement. Conversely, in the second group, vapocoolant spray was applied prior to the first glucose measurement, followed by placebo during the second measurement. This crossover design ensures that each patient serves as their own control, minimizing inter-individual variability and enhancing the reliability of the findings.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faruk Danış, MD, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789055
- Sponsor's protocol ID
- BAIBU-TF-FD-01
- Status last verified
- Jul 2026
- First submitted
- 17 Jan 2025
- Last updated
- 21 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kudu E, Danis F. Efficacy of a Vapocoolant Spray in Reducing Pain During Capillary Glucose Testing: A Randomized Crossover Trial. J Emerg Med. 2026 Jul 17;89:20-28. doi: 10.1016/j.jemermed.2026.07.021. Online ahead of print.
PubMed 42685507
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Vapocoolant Spray in Reducing Pain During Capillary Glucose Testing: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT06789055
- Acronym / sponsor ID
- BAIBU-TF-FD-01
- Conditions
- Visual Analog Pain Scale
- Keywords
- Vapocoolant Spray, Capillary Glucose Testing, Pain Management, Patient Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 23 Jan 2025 (actual)
- Results
- Posted 21 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Capillary blood glucose measurement is a routine procedure in emergency departments, but it may cause pain and discomfort because it requires fingertip puncture. Vapocoolant spray is a rapid, noninvasive, and inexpensive method of topical analgesia that may reduce pain during minor procedures. However, its effectiveness during capillary blood glucose testing has not been sufficiently studied. This study aims to evaluate whether vapocoolant spray reduces pain during capillary blood glucose measurement compared with placebo in adult emergency department patients requiring at least two clinically indicated glucose measurements. In this randomized, placebo-controlled crossover trial, participants receive both vapocoolant spray and placebo in a randomized sequence before two separate capillary glucose measurements. Pain is assessed immediately after each procedure using a 100 mm Visual Analog Scale. The findings may help inform practical strategies to improve patient comfort during routine glucose testing in emergency care settings.
Detailed description
This study is a single-center, randomized, placebo-controlled crossover trial conducted in the emergency department of a tertiary care hospital. The study evaluates the efficacy of vapocoolant spray in reducing pain during capillary blood glucose measurement in adult patients who require at least two clinically indicated capillary glucose measurements during the same emergency department visit.
Capillary blood glucose testing is frequently performed in emergency care and is essential for the evaluation and management of many patients. Although it is considered a minor procedure, repeated fingertip punctures may cause pain, discomfort, and procedure-related distress. Vapocoolant spray produces rapid skin cooling and may provide short-term cutaneous analgesia through temporary reduction of sensory nerve conduction. While vapocoolants have been studied in other needle-related procedures, evidence for their use during capillary blood glucose testing remains limited.
Eligible participants are adults aged 18 years or older who require at least two capillary blood glucose measurements for any clinical indication and who provide informed consent. Participants are randomized to one of two intervention sequences. In one sequence, placebo spray is applied before the first capillary blood glucose measurement and vapocoolant spray is applied before the second measurement. In the other sequence, vapocoolant spray is applied before the first measurement and placebo spray is applied before the second. The second measurement is performed on the corresponding finger of the contralateral hand according to the assigned sequence. No additional punctures beyond those clinically indicated are performed.
Vapocoolant spray containing ethyl chloride is applied from a distance of 30 cm for 10 seconds before the procedure. The placebo consists of sterile water spray applied in the same manner. After spray application, the site is cleansed according to the standard protocol, the fingertip is punctured with a standard lancet, and capillary blood glucose measurement is performed using the study device.
The primary outcome is pain intensity during capillary blood glucose measurement, assessed immediately after each procedure using a 100 mm Visual Analog Scale. Secondary outcomes include adverse events related to spray application, such as pruritus, coolness, numbness, erythema, or burning sensation.
The crossover design allows each participant to serve as their own control, thereby reducing interindividual variability in pain perception. Randomization of intervention order is used to minimize potential sequence and acclimatization effects associated with repeated glucose measurements. The results of this study may support the use of a simple and practical analgesic strategy to improve patient comfort during routine capillary blood glucose testing in emergency department practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study was designed as a randomized crossover trial. Patients requiring at least two capillary blood glucose measurements were included in the study. Participants were randomized into two groups. In the first group, placebo was applied during the first measurement, and vapocoolant spray was used for the second measurement. Conversely, in the second group, vapocoolant spray was applied prior to the first glucose measurement, followed by placebo during the second measurement. This crossover design ensures that each patient serves as their own control, minimizing inter-individual variability and enhancing the reliability of the findings.
| Arm | Type | Receives |
|---|---|---|
| Placebo, Then Vapocoolant Spray | Other | Other: Vapocoolant Spray, Other: PlaceboIn the first group, placebo will be applied prior to the initial capillary blood glucose measurement, after which the measurement will be performed, and the patient's pain level will be assessed using the Visual Analog Scale (VAS). For the subsequent second measurement, Vapocoolant spray will be applied before the procedure, followed by the glucose measurement, which will be conducted on the same finger of the opposite hand as used in the first measurement. The patient's pain level will again be evaluated using the VAS. This sequential approach allows for a direct comparison of pain scores between placebo and Vapocoolant spray applications within the same patient. |
| Vapocoolant Spray, Then Placebo | Other | Other: Vapocoolant Spray, Other: PlaceboIn the second group, Vapocoolant spray will be applied prior to the initial capillary blood glucose measurement, after which the measurement will be performed, and the patient's pain level will be assessed using the Visual Analog Scale (VAS). For the subsequent second measurement, placebo will be applied before the procedure, followed by the glucose measurement, which will be conducted on the same finger of the opposite hand as used in the first measurement.. This sequential approach allows for a direct comparison of pain scores between placebo and Vapocoolant spray applications within the same patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged ≥18 years
- Patients requiring at least two capillary blood glucose measurements for any reason
- Patients who agree to participate in the study
Key exclusion criteria (5 listed)
- Allergy to the components of the spray
- Conditions that may affect capillary blood glucose measurement or pain perception, such as peripheral neuropathy or peripheral arterial disease
- Blood glucose levels outside the measurable range of the capillary device (extremely low or high levels)
- Cognitive disorders that prevent the evaluation of the Visual Analog Scale (VAS), such as dementia, Alzheimer's disease, or cerebrovascular diseases
- Severe conditions in other parts of the body that may interfere with pain evaluation
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 |
|---|---|---|
| Vapocoolant SprayBefore the capillary blood glucose measurement, vapocoolant spray will be applied to the measurement site from a distance of 30 cm for 10 seconds. Following this, the area will be cleansed with an antimicrobial swab for 10 seconds using a circular motion, starting from the center and moving outward. Subsequently, the fingertip will be punctured with a lancet to obtain a blood sample. The first drop of blood will be wiped away with cotton, and the glucose measurement will be performed using the subsequent drop utilizing the Standard GlucoNavii GDH device. The patient will then be asked to assess their pain during the procedure using the Visual Analog Scale (VAS) for pain evaluation. | Other | Placebo, Then Vapocoolant Spray, Vapocoolant Spray, Then Placebo |
| PlaceboBefore the capillary blood glucose measurement, placebo will be applied to the measurement site from a distance of 30 cm for 10 seconds. Following this, the area will be cleansed with an antimicrobial swab for 10 seconds using a circular motion, starting from the center and moving outward. Subsequently, the fingertip will be punctured with a lancet to obtain a blood sample. The first drop of blood will be wiped away with cotton, and the glucose measurement will be performed using the subsequent drop utilizing the Standard GlucoNavii GDH device. The patient will then be asked to assess their pain during the procedure using the Visual Analog Scale (VAS) for pain evaluation. | Other | Placebo, Then Vapocoolant Spray, Vapocoolant Spray, Then Placebo |
Primary outcome
Visual Analog Pain Scale
Time frame: Immediately after blood glucose measurement, assessed within the first 5 minutes after the procedure.
The primary outcome of this study is the Visual Analog Scale (VAS) score for pain. The VAS is a widely used assessment tool to evaluate variables across a continuum, such as acute pain severity. For the purpose of this study, patients will be presented with a 100-mm line, where one end is labeled "no pain" and the other end is labeled "severe pain." The scale ranges from 0 to 100, with 0 corresponding to no pain and 100 corresponding to severe pain. After each capillary blood glucose measurement, patients will be asked to mark their level of pain on the VAS line based on their experience during the procedure. The VAS score will be determined by measuring the distance in millimeters from the "no pain" end to the point marked by the patient. Higher scores indicate greater pain and therefore a worse outcome. This standardized and validated method provides a quantitative measure of pain that is both simple and reliable for clinical use.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42685507Kudu E, Danis F. Efficacy of a Vapocoolant Spray in Reducing Pain During Capillary Glucose Testing: A Randomized Crossover Trial. J Emerg Med. 2026 Jul 17;89:20-28. doi: 10.1016/j.jemermed.2026.07.021. Online ahead of print.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vapocoolant Spray in people with Visual Analog Pain Scale, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 21 Jul 2026. 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 Turkey (Türkiye). 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. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analog Pain Scale (time frame: Immediately after blood glucose measurement, assessed within the first 5 minutes after the procedure.). 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 NCT06789055, which also lists 1 linked publication.
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 21 Jul 2026.