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OpenTrials
Completed

NCT Number: NCT06789055

Vapocoolant Spray's Role in Reducing Pain During Capillary Glucose Testing

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bolu Abant Izzet Baysal University

Bolu, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vapocoolant spray

Other

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.

Placebo

Other

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

Efficacy of a Vapocoolant Spray in Reducing Pain During Capillary Glucose Testing: A Randomized Crossover Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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