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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-06-30

Brief Summary

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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

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Conditions

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Blood Gas Analysis Topical Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

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.

Group Type ACTIVE_COMPARATOR

Lidocaine spray

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Intervention Type DRUG

Lidocaine spray

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haydarpasa Numune Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sinem Dogruyol

Associate Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Haydarpasa Numune Training and Research Hospital

Istanbul, Uskudar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2024-KAEK-64

Identifier Type: -

Identifier Source: org_study_id

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