Clinical trial NCT06918340: Evaluation of Analgesic Efficacy of Lidocaine and Diclofenac Spray in Radial Artery Blood Gas Sampling by Visual Analogue Scale and Perfusion Index
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Blood Gas Analysis
Topical Analgesia
Lead sponsor: Haydarpasa Numune Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 placebo. The main questions it aims to answer are:

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change in pain scores associated with radial artery blood gas sampling
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Training and Research Hospital
state: Uskudar
Study officials:
References: