Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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;
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac | Drug | Group II: 5-6 puffs of topical 1% diclofenac spray will be applied before radial artery blood gas sampling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haydarpasa Numune Training and Research Hospital | Istanbul | Uskudar | 34843 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41576782 | Derived | 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. 2026 Feb;81:39-47. doi: 10.1016/j.jemermed.2025.12.015. Epub 2025 Dec 16. |
Not provided
Not provided
all collected IPD, all IPD that underlie results in a publication
12 months ( 01.01.2025-01.01.2026)
The researcher responsible for data analysis will be authorised to access IPD for 1 year.
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 10, 2025 | |
| Reset | Jul 28, 2025 | |
| Release | Aug 18, 2025 |
Not provided
Not provided
Not provided
Not provided
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.
| 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. |
|
| Reset | Sep 5, 2025 |
| Release | Dec 13, 2025 |
| Reset | Dec 31, 2025 |
| Release | Jan 5, 2026 |
| Reset | Jan 21, 2026 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 10, 2025 | Jul 28, 2025 | |||
| Aug 18, 2025 | Sep 5, 2025 | |||
| Dec 13, 2025 | Dec 31, 2025 | |||
| Jan 5, 2026 | Jan 21, 2026 |
| ID | Term |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided