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

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.

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Key information

Conditions

Blood Gas Analysis Topical Analgesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Haydarpasa Numune Training and Research Hospital

Istanbul, Uskudar, 34843, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diclofenac

Drug

Group II: 5-6 puffs of topical 1% diclofenac spray will be applied before radial artery blood gas sampling.

Lidocaine spray

Drug

Group I: 5-6 puffs of topical 10% lidocaine spray will be applied before radial artery blood gas sampling.

Placebo

Other

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Haydarpasa Numune Training and Research Hospital

Other

Registry information

Official study 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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Apr 9, 2025
Registry last updated: Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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