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

NCT06918340 | Active Not Recruiting Phase 4

• 1 other identifier: 2024-KAEK-64
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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. 1.be administered in same three spray bottles to ensure blinding in the groups.
2. 2.Randomisation will be done by closed envelope method.
3. 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. 4.Any side effects due to medication will be recorded.

Conditions

Blood Gas Analysis; Topical Analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (3)

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.

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.

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.

Other: Placebo

Interventions

Diclofenac DRUG

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

Group II: topical 1% diclofenac spray

Lidocaine spray DRUG

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

Group I: 5-6 puffs of topical 10% lidocaine spray

Placebo OTHER

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

Group III: topical 70% alcohol solution spray

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

Study Sites (1)

Haydarpasa Numune Training and Research Hospital

Istanbul, Uskudar, 34843, Turkey (Türkiye)

Location

Related Publications (1)

• 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. 2025 Dec 16;81:39-47. doi: 10.1016/j.jemermed.2025.12.015. Online ahead of print.

  PMID: 41576782 DERIVED

MeSH Terms

Interventions

Diclofenac

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Topical treatments will be administered in 100 cc amber coloured glass spray bottles to ensure blinding in all three treatment groups. The bottles will be prepared by the responsible investigator and numbered with the number on the sealed envelope. Thus, it will be ensured that the treating staff and the patient will be blinded to the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Doctor

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 9, 2025
• Study Start: November 1, 2024
• Primary Completion: December 15, 2024
• Study Completion: June 30, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: 12 months ( 01.01.2025-01.01.2026)
• Access Criteria: The researcher responsible for data analysis will be authorised to access IPD for 1 year.

Locations

TU (1)