Trial Outcomes & Findings for Vapocoolant Spray's Role in Reducing Pain During Capillary Glucose Testing (NCT NCT06789055)
NCT ID: NCT06789055
Last Updated: 2026-07-21
Results Overview
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.
COMPLETED
NA
80 participants
Immediately after blood glucose measurement, assessed within the first 5 minutes after the procedure.
2026-07-21
Participant Flow
Participants were consecutively enrolled from the emergency department of a tertiary university training and research hospital between March 10 and March 14, 2025. Eligible adults required at least two clinically indicated capillary blood glucose measurements during the ED visit and provided written informed consent.
Of 109 patients assessed for eligibility, 29 were not randomized: 7 declined participation, 3 had conditions impairing pain perception, 4 had insufficient consciousness for VAS assessment, and 15 had other factors that could affect pain evaluation. Eighty participants were randomized.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Received analgesic treatment
|
1
|
0
|
|
Overall Study
Underwent surgical procedure
|
0
|
1
|
|
Overall Study
Deterioration of consciousness
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Participants
n=80 Participants
All randomized participants included in the baseline characteristics population of the crossover trial.
|
|---|---|
|
Age, Continuous
|
65 years
n=80 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=80 Participants
|
|
Diabetes Mellitus
|
57 Participants
n=80 Participants
|
|
Oral antidiabetic use
|
45 Participants
n=80 Participants
|
|
Insulin therapy
|
19 Participants
n=80 Participants
|
|
Hypertension
|
45 Participants
n=80 Participants
|
|
Coronary artery disease
|
24 Participants
n=80 Participants
|
|
Chronic kidney disease
|
12 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Vapocoolant Spray
n=77 Participants
Participants received vapocoolant spray before a clinically indicated capillary blood glucose measurement. Pain was assessed immediately after the measurement using a 100-mm Visual Analog Scale.
|
Placebo
n=77 Participants
Participants received placebo spray, sterile water, before a clinically indicated capillary blood glucose measurement. Pain was assessed immediately after the measurement using a 100-mm Visual Analog Scale.
|
|---|---|---|
|
Visual Analog Pain Scale
|
29 scores on a scale
Interval 18.0 to 43.0
|
40 scores on a scale
Interval 31.0 to 56.0
|
Adverse Events
Vapocoolant Spray
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vapocoolant Spray
n=79 participants at risk
Participants received vapocoolant spray before a clinically indicated capillary blood glucose measurement. Pain was assessed immediately after the measurement using a 100-mm Visual Analog Scale.
|
Placebo
n=78 participants at risk
Participants received placebo spray, sterile water, before a clinically indicated capillary blood glucose measurement. Pain was assessed immediately after the measurement using a 100-mm Visual Analog Scale.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
1/79 • From spray application through immediate post-procedure assessment after each capillary blood glucose measurement
Adverse events were assessed immediately after each capillary blood glucose measurement. Events included local symptoms such as pruritus, coolness with numbness, erythema, and burning sensation.
|
0.00%
0/78 • From spray application through immediate post-procedure assessment after each capillary blood glucose measurement
Adverse events were assessed immediately after each capillary blood glucose measurement. Events included local symptoms such as pruritus, coolness with numbness, erythema, and burning sensation.
|
|
General disorders
Coolness with numbness
|
2.5%
2/79 • From spray application through immediate post-procedure assessment after each capillary blood glucose measurement
Adverse events were assessed immediately after each capillary blood glucose measurement. Events included local symptoms such as pruritus, coolness with numbness, erythema, and burning sensation.
|
1.3%
1/78 • From spray application through immediate post-procedure assessment after each capillary blood glucose measurement
Adverse events were assessed immediately after each capillary blood glucose measurement. Events included local symptoms such as pruritus, coolness with numbness, erythema, and burning sensation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place