PainNCT07728162
Cold Spray for Insulin-Injection Pain in the Emergency Department
A study testing Cold (vapocoolant) spray in people with Pain and Diabetes Mellitus, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This randomized, double-blind, placebo-controlled, within-patient crossover trial evaluated whether a vapocoolant (cold) spray applied before subcutaneous insulin injection reduces injection pain compared with a placebo (sterile-water) spray in adults treated in a tertiary-care emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Diabetes Mellitus
- What is being tested?
- Cold (vapocoolant) spray
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2025to 1 Apr 2025
- 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
- Age 18 years or older
- Receiving subcutaneous insulin in the emergency department
- Expected to require at least one further subcutaneous insulin injection during the same encounter
- Able to complete a 100-mm visual analog scale (VAS)
Who cannot join
- Allergy to the spray content
- Local abnormality at the intended abdominal injection site (e.g., active skin infection, hematoma, extensive scarring, or lipohypertrophy)
- Cognitive condition precluding reliable VAS assessment (e.g., dementia or Alzheimer disease)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Izzet Baysal Training and Research Hospital
Bolu, 14030
About this study
Official title: Cold Spray for Pain Reduction During Subcutaneous Insulin Injection in the Emergency Department: A Randomized, Placebo-Controlled, Two-Period Crossover Trial
This randomized, double-blind, placebo-controlled, within-patient crossover trial evaluated whether a vapocoolant (cold) spray applied before subcutaneous insulin injection reduces injection pain compared with a placebo (sterile-water) spray in adults treated in a tertiary-care emergency department. Each participant received a cold spray before one clinically indicated insulin injection and a placebo spray before another, in randomized order, and marked injection pain on a 100-mm visual analog scale 10 seconds after each injection. The within-patient design allowed each participant to serve as their own control.
Read the detailed description
Adults (>=18 years) receiving subcutaneous insulin in the emergency department and expected to require at least one further subcutaneous insulin injection during the same encounter were allocated 1:1 to one of two treatment sequences using block randomization (block size 4). Sequence 1 received the placebo (sterile-water) spray at the first eligible injection and the cold spray at the next; Sequence 2 received the conditions in reverse order. Allocation was concealed with sequentially numbered, opaque, sealed envelopes. The cold-spray and placebo canisters were identical and over-wrapped in identical opaque covering labeled only as canister number one or canister number two, so that both the participant and the administering clinician were blinded to allocation.
All injections were given in the abdomen (at least 5 cm from the umbilicus, alternating sides) using short-acting regular human insulin (100 IU/mL) at room temperature, administered with a 1-mL single-use syringe and a 25-gauge (0.50 x 25 mm) needle. For the active condition the cold spray was applied to the intended injection area for approximately 10 seconds from approximately 30 cm, and the injection was performed approximately 10 seconds later; the needle was kept in the skin for approximately 10 seconds before withdrawal. The placebo spray was delivered in an identical manner. The insulin dose, the interval between the two injections, and the timing of care followed routine clinical practice and were not standardized by the protocol.
The primary outcome was injection pain measured by each participant on a 100-mm paper visual analog scale (0 = no pain, 100 = worst pain imaginable) 10 seconds after each injection, recorded in millimeters. The primary analysis compared the within-patient VAS difference (cold spray minus placebo) across paired observations, with the validity of the crossover design examined using the standard two-by-two decomposition into carry-over, period, and treatment effects.
- Conditions
- Pain, Diabetes Mellitus
- Being tested
- Cold (vapocoolant) spray, Placebo (sterile-water) spray
- Keywords
- cold spray, vapocoolant, injection pain, insulin, visual analog scale, emergency department
- Medical subject headings
- Pain, Diabetes Mellitus, Insulin Resistance, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold (vapocoolant) sprayOther
A vapocoolant (cold) spray applied to the intended abdominal injection site for approximately 10 seconds from approximately 30 cm; the subcutaneous insulin injection was performed approximately 10 seconds later, and the needle was kept in the skin for approximately 10 seconds before withdrawal.
Placebo (sterile-water) sprayOther
A sterile-water placebo spray delivered in an identical manner to the active spray (same device handling, distance, and duration) before the subcutaneous insulin injection.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Placebo-first | Experimental | Placebo (sterile-water) spray before the first eligible subcutaneous insulin injection, then cold (vapocoolant) spray before the next injection. Receives: Other: Cold (vapocoolant) spray; Other: Placebo (sterile-water) spray |
| Sequence 2: Spray-first | Experimental | Cold (vapocoolant) spray before the first eligible subcutaneous insulin injection, then placebo (sterile-water) spray before the next injection. Receives: Other: Cold (vapocoolant) spray; Other: Placebo (sterile-water) spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection pain on a 100-mm visual analog scale (VAS)
Injection pain measured by each participant on a 100-mm paper visual analog scale (0 = no pain, 100 = worst pain imaginable), measured with a ruler and recorded in millimeters. Compared within-patient between the cold-spray and placebo conditions.
Measured: 10 seconds after each injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start5 Feb 2025
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 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
- Investigators
- Faruk Danis, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728162
- Sponsor's protocol ID
- BAIBU-EM-2024-386
- Other IDs
- 2024/386
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Spray for Pain Reduction During Subcutaneous Insulin Injection in the Emergency Department: A Randomized, Placebo-Controlled, Two-Period Crossover Trial
- ClinicalTrials.gov ID
- NCT07728162
- Acronym / sponsor ID
- BAIBU-EM-2024-386
- Conditions
- Pain, Diabetes Mellitus
- Keywords
- cold spray, vapocoolant, injection pain, insulin, visual analog scale, emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 27 Jul 2026 (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 randomized, double-blind, placebo-controlled, within-patient crossover trial evaluated whether a vapocoolant (cold) spray applied before subcutaneous insulin injection reduces injection pain compared with a placebo (sterile-water) spray in adults treated in a tertiary-care emergency department. Each participant received a cold spray before one clinically indicated insulin injection and a placebo spray before another, in randomized order, and marked injection pain on a 100-mm visual analog scale 10 seconds after each injection. The within-patient design allowed each participant to serve as their own control.
Detailed description
Adults (>=18 years) receiving subcutaneous insulin in the emergency department and expected to require at least one further subcutaneous insulin injection during the same encounter were allocated 1:1 to one of two treatment sequences using block randomization (block size 4). Sequence 1 received the placebo (sterile-water) spray at the first eligible injection and the cold spray at the next; Sequence 2 received the conditions in reverse order. Allocation was concealed with sequentially numbered, opaque, sealed envelopes. The cold-spray and placebo canisters were identical and over-wrapped in identical opaque covering labeled only as canister number one or canister number two, so that both the participant and the administering clinician were blinded to allocation.
All injections were given in the abdomen (at least 5 cm from the umbilicus, alternating sides) using short-acting regular human insulin (100 IU/mL) at room temperature, administered with a 1-mL single-use syringe and a 25-gauge (0.50 x 25 mm) needle. For the active condition the cold spray was applied to the intended injection area for approximately 10 seconds from approximately 30 cm, and the injection was performed approximately 10 seconds later; the needle was kept in the skin for approximately 10 seconds before withdrawal. The placebo spray was delivered in an identical manner. The insulin dose, the interval between the two injections, and the timing of care followed routine clinical practice and were not standardized by the protocol.
The primary outcome was injection pain measured by each participant on a 100-mm paper visual analog scale (0 = no pain, 100 = worst pain imaginable) 10 seconds after each injection, recorded in millimeters. The primary analysis compared the within-patient VAS difference (cold spray minus placebo) across paired observations, with the validity of the crossover design examined using the standard two-by-two decomposition into carry-over, period, and treatment effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Placebo-first | Experimental | Other: Cold (vapocoolant) spray, Other: Placebo (sterile-water) sprayPlacebo (sterile-water) spray before the first eligible subcutaneous insulin injection, then cold (vapocoolant) spray before the next injection. |
| Sequence 2: Spray-first | Experimental | Other: Cold (vapocoolant) spray, Other: Placebo (sterile-water) sprayCold (vapocoolant) spray before the first eligible subcutaneous insulin injection, then placebo (sterile-water) spray before the next injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Receiving subcutaneous insulin in the emergency department
- Expected to require at least one further subcutaneous insulin injection during the same encounter
- Able to complete a 100-mm visual analog scale (VAS)
Key exclusion criteria (3 listed)
- Allergy to the spray content
- Local abnormality at the intended abdominal injection site (e.g., active skin infection, hematoma, extensive scarring, or lipohypertrophy)
- Cognitive condition precluding reliable VAS assessment (e.g., dementia or Alzheimer disease)
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 |
|---|---|---|
| Cold (vapocoolant) sprayA vapocoolant (cold) spray applied to the intended abdominal injection site for approximately 10 seconds from approximately 30 cm; the subcutaneous insulin injection was performed approximately 10 seconds later, and the needle was kept in the skin for approximately 10 seconds before withdrawal. | Other | Sequence 1: Placebo-first, Sequence 2: Spray-first |
| Placebo (sterile-water) sprayA sterile-water placebo spray delivered in an identical manner to the active spray (same device handling, distance, and duration) before the subcutaneous insulin injection. | Other | Sequence 1: Placebo-first, Sequence 2: Spray-first |
Primary outcome
Injection pain on a 100-mm visual analog scale (VAS)
Time frame: 10 seconds after each injection
Injection pain measured by each participant on a 100-mm paper visual analog scale (0 = no pain, 100 = worst pain imaginable), measured with a ruler and recorded in millimeters. Compared within-patient between the cold-spray and placebo conditions.
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 27 Jul 2026.
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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.
Faruk Danis principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold (vapocoolant) spray in people with Pain and Diabetes Mellitus, 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 4 inclusion and 3 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 27 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?
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?
Injection pain on a 100-mm visual analog scale (VAS) (time frame: 10 seconds after each injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2026.