Blood Gas AnalysisPhase 4NCT06918340
Evaluation of Analgesic Efficacy of Lidocaine and Diclofenac Spray in Radial Artery Blood Gas Sampling by Visual Analogue Scale and Perfusion Index
A Phase 4 study testing Diclofenac and Lidocaine spray in people with Blood Gas Analysis and Topical Analgesia, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial is to evaluate the analgesic efficacy of lidocaine and diclofenac sprays to be administered before the procedure in cases admitted to the emergency department and requiring radial artery blood gas sampling by means of visual pain scale (VAS) and perfusion index in comparison with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Blood Gas Analysis, Topical Analgesia
- What is being tested?
- Diclofenac and Lidocaine spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 30 Jun 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65.
- Having clinical indication for radial artery blood gas sampling
- Being conscious, co-operative and orientated
- Those who approved the informed consent form
Who cannot join
- Being under 18 years of age.
- Being pregnant or breastfeeding.
- Not being conscious, co-operative and orientated (impaired consciousness)
- Being used painkillers in the last 24 hours
- Radial artery blood gas sampling on the same day (more than one application)
- Presence of cardiac arrhythmia
Show all 12Show fewer
- Have a diagnosis of neuropathy (including diabetic neuropathy)
- Having a diagnosis of anxiety and panic disorder
- Using a sustained-release dermal analgesic patch (fentanyl)
- Patient unable to comply with the visual analogue pain scale (VAS) due to language barrier
- Presence of a condition such as dementia, etc. that may lead to a change in consciousness
- Allergy to lidocaine or diclofenac
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpasa Numune Training and Research Hospital
Istanbul, Uskudar, 34843
About this study
Official title: Evaluation of Analgesic Efficacy of Lidocaine and Diclofenac Spray in Radial Artery Blood Gas Sampling by Visual Analogue Scale (VAS) and Perfusion Index: A Randomised, Placebo-Controlled Study
The aim of this clinical trial is to evaluate the analgesic efficacy of lidocaine and diclofenac sprays to be administered before the procedure in cases admitted to the emergency department and requiring radial artery blood gas sampling by means of visual pain scale (VAS) and perfusion index in comparison with placebo. The main questions it aims to answer are:
- Is there a difference between the efficacy of two different sprays? 2. Is there a significant difference between the side effects of two different sprays? Researchers will compare diclofenac sodium, lidocain and placebo sprays. Treatments will;
- be administered in same three spray bottles to ensure blinding in the groups.
- Randomisation will be done by closed envelope method.
- Numerical Pain Scale (NRS) will be used to evaluate the analgesic efficacy of the sprays. NRS scores will be recorded in both groups before starting blood gas sampling (baseline) and after blood gas sampling.
- Any side effects due to medication will be recorded.
- Conditions
- Blood Gas Analysis, Topical Analgesia
- Being tested
- Diclofenac, Lidocaine spray, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
Group II: 5-6 puffs of topical 1% diclofenac spray will be applied before radial artery blood gas sampling.
Lidocaine sprayDrug
Group I: 5-6 puffs of topical 10% lidocaine spray will be applied before radial artery blood gas sampling.
PlaceboOther
Group III: 5-6 puffs of topical 70% alcohol solution spray will be applied before radial artery blood gas sampling.
| Study group | Role | What they receive |
|---|---|---|
| Group I: 5-6 puffs of topical 10% lidocaine spray | Active comparator | Group I: 5-6 puffs of topical 10% lidocaine spray will be applied before radial artery blood gas sampling. Receives: Drug: Lidocaine spray |
| Group II: topical 1% diclofenac spray | Active comparator | Group II: 5-6 puffs of topical 1% diclofenac spray will be applied before radial artery blood gas sampling. Receives: Drug: Diclofenac |
| Group III: topical 70% alcohol solution spray | Placebo comparator | Group III: 5-6 puffs of topical 70% alcohol solution spray will be applied before radial artery blood gas sampling. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores associated with radial artery blood gas sampling
The primary outcome of the study was the change in pain associated with radial artery blood gas sampling. It is aimed to provide patient comfort with spray applications. Differences between the 3 groups in VAS scores related to the intervention will be analysed.
Measured: Baseline perfusion index and baseline VAS will be measured and recorded. 10 minutes after blood gas sampling, perfusion index and VAS score will be recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Nov 2024
- Primary completion15 Dec 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Gas AnalysisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Dogruyol, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918340
- Sponsor's protocol ID
- 2024-KAEK-64
- Status last verified
- Jun 2025
- First submitted
- 28 Mar 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Publications
Altundag I, Dogruyol S, Yavuz BG, Afacan MA, Colak S. 10% Lidocaine Versus 1% Diclofenac Spray in Radial Arterial Blood Gas Sampling: A Randomized, Double-Blind, Placebo-Controlled Trial using Perfusion Index. J Emerg Med. 2026 Feb;81:39-47. doi: 10.1016/j.jemermed.2025.12.015. Epub 2025 Dec 16.
PubMed 41576782
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Analgesic Efficacy of Lidocaine and Diclofenac Spray in Radial Artery Blood Gas Sampling by Visual Analogue Scale (VAS) and Perfusion Index: A Randomised, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT06918340
- Acronym / sponsor ID
- 2024-KAEK-64
- Conditions
- Blood Gas Analysis, Topical Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 9 Apr 2025 (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.
The aim of this clinical trial is to evaluate the analgesic efficacy of lidocaine and diclofenac sprays to be administered before the procedure in cases admitted to the emergency department and requiring radial artery blood gas sampling by means of visual pain scale (VAS) and perfusion index in comparison with placebo. The main questions it aims to answer are:
- Is there a difference between the efficacy of two different sprays? 2. Is there a significant difference between the side effects of two different sprays? Researchers will compare diclofenac sodium, lidocain and placebo sprays. Treatments will;
- be administered in same three spray bottles to ensure blinding in the groups.
- Randomisation will be done by closed envelope method.
- Numerical Pain Scale (NRS) will be used to evaluate the analgesic efficacy of the sprays. NRS scores will be recorded in both groups before starting blood gas sampling (baseline) and after blood gas sampling.
- Any side effects due to medication will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I: 5-6 puffs of topical 10% lidocaine spray | Active comparator | Drug: Lidocaine sprayGroup I: 5-6 puffs of topical 10% lidocaine spray will be applied before radial artery blood gas sampling. |
| Group II: topical 1% diclofenac spray | Active comparator | Drug: DiclofenacGroup II: 5-6 puffs of topical 1% diclofenac spray will be applied before radial artery blood gas sampling. |
| Group III: topical 70% alcohol solution spray | Placebo comparator | Other: PlaceboGroup III: 5-6 puffs of topical 70% alcohol solution spray will be applied before radial artery blood gas sampling. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between the ages of 18-65.
- Having clinical indication for radial artery blood gas sampling
- Being conscious, co-operative and orientated
- Those who approved the informed consent form
Key exclusion criteria (12 listed)
- Being under 18 years of age.
- Being pregnant or breastfeeding.
- Not being conscious, co-operative and orientated (impaired consciousness)
- Being used painkillers in the last 24 hours
- Radial artery blood gas sampling on the same day (more than one application)
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 |
|---|---|---|
| DiclofenacGroup II: 5-6 puffs of topical 1% diclofenac spray will be applied before radial artery blood gas sampling. | Drug | Group II: topical 1% diclofenac spray |
| Lidocaine sprayGroup I: 5-6 puffs of topical 10% lidocaine spray will be applied before radial artery blood gas sampling. | Drug | Group I: 5-6 puffs of topical 10% lidocaine spray |
| PlaceboGroup III: 5-6 puffs of topical 70% alcohol solution spray will be applied before radial artery blood gas sampling. | Other | Group III: topical 70% alcohol solution spray |
Primary outcome
Change in pain scores associated with radial artery blood gas sampling
Time frame: Baseline perfusion index and baseline VAS will be measured and recorded. 10 minutes after blood gas sampling, perfusion index and VAS score will be recorded.
The primary outcome of the study was the change in pain associated with radial artery blood gas sampling. It is aimed to provide patient comfort with spray applications. Differences between the 3 groups in VAS scores related to the intervention will be analysed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Derived from this study: PubMed 41576782Altundag I, Dogruyol S, Yavuz BG, Afacan MA, Colak S. 10% Lidocaine Versus 1% Diclofenac Spray in Radial Arterial Blood Gas Sampling: A Randomized, Double-Blind, Placebo-Controlled Trial using Perfusion Index. J Emerg Med. 2026 Feb;81:39-47. doi: 10.1016/j.jemermed.2025.12.015. Epub 2025 Dec 16.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
Related trials for Blood Gas Analysis
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruitingPhase 3
Interest of Cryotherapy in Reducing Pain During Radial Arterial Blood Sampling
Chronic Respiratory Diseases
Not yet recruiting
Jigsaw and Audience Response System for Arterial Blood Gas Education
Nursing Education
Recruiting
Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
Ventilator Associated Bacterial Pneumonia (VABP), Critical Illness
RecruitingObservational study
An Investigation of The Relationship Between Muscle Mass, Physiological Parameters, and Blood Gas Levels in Adult Patients Hospitalized in The Intensive Care Unit
Intensive Care (ICU)
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 Phase 4 study testing Diclofenac and Lidocaine spray in people with Blood Gas Analysis and Topical Analgesia, run by Haydarpasa Numune Training and Research Hospital 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 12 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in pain scores associated with radial artery blood gas sampling (time frame: Baseline perfusion index and baseline VAS will be measured and recorded. 10 minutes after blood gas sampling, perfusion index and VAS score will be recorded.). 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 NCT06918340, 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 26 Jun 2025.