Evaluation of Analgesic Efficacy of Lidocaine and Diclofenac Spray in Radial Artery Blood Gas Sampling by Visual Analogue Scale and Perfusion Index

Phase 4

Active, not recruiting

• Conditions: Blood Gas Analysis; Topical Analgesia
• Interventions: Drug: Lidocaine spray; Drug: Diclofenac; Other: Placebo

• Registration Number: NCT06918340
• Lead Sponsor: Haydarpasa Numune Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-01
• Primary Completion: 2024-12-15
• Study First Submitted: 2025-03-28
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-06
• Last Update Submitted: 2025-04-06
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I: 5-6 puffs of topical 10% lidocaine spray	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	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	Placebo	Group III: 5-6 puffs of topical 70% alcohol solution spray will be applied before radial artery blood gas sampling.

Primary Outcome Measures

Name	Time	Method
Change in pain scores associated with radial artery blood gas sampling	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.

Trial Locations

Locations (1)

Haydarpasa Numune Training and Research Hospital; 🇹🇷 Istanbul, Uskudar, Turkey