- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06789055
Vapocoolant Spray's Role in Reducing Pain During Capillary Glucose Testing
Efficacy of a Vapocoolant Spray in Reducing Pain During Capillary Glucose Testing: A Randomized Crossover Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bolu, Turkey (Türkiye)
- Bolu abant Izzet Baysal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged ≥18 years
- Patients requiring at least two capillary blood glucose measurements for any reason
- Patients who agree to participate in the study
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Placebo, Then Vapocoolant Spray
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.
|
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.
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.
|
|
Other: Vapocoolant Spray, Then Placebo
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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."
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.
This standardized and validated method provides a quantitative measure of pain that is both simple and reliable for clinical use.
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Immediately after blood glucose measurement, assessed within the first 5 minutes after the procedure.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAIBU-TF-FD-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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