Evaluation of Analgesic Efficacy of Lidocaine and Diclofenac Spray in Radial Artery Blood Gas Sampling by Visual Analogue Scale and Perfusion Index
NCT ID: NCT06918340
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
150 participants
INTERVENTIONAL
2024-11-01
2025-06-30
Brief Summary
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1\. 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;
1. be administered in same three spray bottles to ensure blinding in the groups.
2. Randomisation will be done by closed envelope method.
3. 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.
4. Any side effects due to medication will be recorded.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group I: 5-6 puffs of topical 10% lidocaine spray
Group I: 5-6 puffs of topical 10% lidocaine spray will be applied before radial artery blood gas sampling.
Lidocaine spray
Group I: 5-6 puffs of topical 10% lidocaine spray will be applied before radial artery blood gas sampling.
Group II: topical 1% diclofenac spray
Group II: 5-6 puffs of topical 1% diclofenac spray will be applied before radial artery blood gas sampling.
Diclofenac
Group 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
Group III: 5-6 puffs of topical 70% alcohol solution spray will be applied before radial artery blood gas sampling.
Placebo
Group III: 5-6 puffs of topical 70% alcohol solution spray will be applied before radial artery blood gas sampling.
Interventions
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Diclofenac
Group II: 5-6 puffs of topical 1% diclofenac spray will be applied before radial artery blood gas sampling.
Lidocaine spray
Group I: 5-6 puffs of topical 10% lidocaine spray will be applied before radial artery blood gas sampling.
Placebo
Group III: 5-6 puffs of topical 70% alcohol solution spray will be applied before radial artery blood gas sampling.
Eligibility Criteria
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Inclusion Criteria
* Having clinical indication for radial artery blood gas sampling
* Being conscious, co-operative and orientated
* Those who approved the informed consent form
Exclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Haydarpasa Numune Training and Research Hospital
OTHER
Responsible Party
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Sinem Dogruyol
Associate Professor Doctor
Locations
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Haydarpasa Numune Training and Research Hospital
Istanbul, Uskudar, Turkey (Türkiye)
Countries
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Other Identifiers
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2024-KAEK-64
Identifier Type: -
Identifier Source: org_study_id
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