Comparison of Low-cost Interventions for Pain Reduction During Radial Artery Puncture in the Emergency Department: A Three-arm Randomized Controlled Trial

The objective of this clinical trial is to investigate if local anesthesia using topical analgesic drug (10% lidocaine spray) or cryo-analgesic (Ice pack) can reduce pain levels during and after arterial blood sampling procedure. The research questions of this study includes:

• Can local anesthesia using topical analgesic drug (10% lidocaine spray) or cryo-analgesic (Ice pack) reduce pain levels during arterial blood sampling?
• Is the first-attempt success rate of arterial blood sampling higher when using local anesthesia (lidocaine spray or ice pack) compared to standard practice without anesthesia?

Study Overview

• Status: Completed
• Conditions: Pain Control
• Intervention / Treatment: Other: Local anesthesia methods

Detailed Description

This single center randomized controlled trial was conducted at the Emergency Department of Queen Savang Vadhana Memorial Hospital, Thailand.

Total of 126 Participants will be sequentially assigned to one of three study groups (A, B, or C) to receive different local anesthesia methods prior to arterial blood sampling procedure.

• Group A (Cold Application): A standard cold pack chilled to -4°C will be applied to the arterial puncture site for 2 minutes. Following cleaning, the physician will immediately perform the arterial blood sampling.
• Group B (Topical Anesthetic): 10% lidocaine spray will be applied to the puncture site, covering a circular area with a 2-3 cm radius. After allowing 2 minutes for anesthetic effect, the site will be cleaned and the physician will perform the arterial blood sampling.
• Group C (Control): This group will receive standard antiseptic preparation with chlorhexidine in alcohol applied in a circular area with a 2-3 cm around the puncture site. After 2 minutes, the site will be cleaned and the physician will perform the arterial blood sampling.

Participants will complete a questionnaire assessing pain levels both during and after the arterial blood sampling procedure. Arterial blood sampling procedure was conducted by trained research assistants or attending experienced physicians.

All collected data will be entered into a secure, encrypted form, ensuring patient confidentiality and preventing access to individual patient identifiers.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chon Buri, Thailand, 20110
    • Queen Savang Vadhana Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18 years or older, who present to the emergency department of Queen Savang Vadhana Memorial Hospital that requires arterial blood sampling procedure for diagnostic purposes

Exclusion Criteria:

• Altered level of consciousness (Glasgow Coma Scale < 15)
• Cognitive impairment or communication barriers precluding accurate pain assessment (e.g., severe dementia, aphasia, intoxication, delirium)
• Contraindications to radial artery cannulation (e.g., severe peripheral vascular disease, history of arteriovenous fistula at the puncture site, active infection at the puncture site)
• Pregnancy
• Need for emergency management which any delay could worsen patient care (e.g., cardiac arrest, respiratory failure requiring immediate intubation)
• Known allergy or hypersensitivity to lidocaine or amide-type local anesthetics
• Severe pain from other sources that could distracting pain assessment related to the arterial blood sampling procedure (e.g., significant trauma, bone fractures, severe burns)
• Failure to obtain successful arterial access after two attempts by an experienced operator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryo-analgesic group (Ice pack); A standard cold pack chilled to -4°C will be applied to the arterial puncture site for 2 minutes. Following antiseptic cleaning and the physician will immediately perform the arterial blood sampling procedure with heparinized 3mL arterial blood gas syringe with a 22G x 1" needle.	Other: Local anesthesia methods; Local pain control method before arterial blood sampling procedure
Experimental: Analgesic drug group (10% lidocaine spray); 10% lidocaine spray will be applied to the puncture site, covering a circular area (2-3 cm radius) around the puncture site for 2 minutes. Following antiseptic cleaning and the physician will immediately perform the arterial blood sampling procedure with heparinized 3mL arterial blood gas syringe with a 22G x 1" needle.	Other: Local anesthesia methods; Local pain control method before arterial blood sampling procedure
No Intervention: Control group (2% Chlorhexidine alcohol); This group will receive standard antiseptic preparation with chlorhexidine in alcohol applied in a circular area (2-3 cm radius) around the puncture site for 2 minutes. Following antiseptic cleaning and the physician will immediately perform the arterial blood sampling procedure with heparinized 3mL arterial blood gas syringe with a 22G x 1" needle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score both during and after the arterial blood sampling procedure.	Pain score will be assessed using a horizontal numeric Rating Scale (NRS) ranging from 0 to 10, with 0 representing "no pain" and 10 representing "the worst pain."	Participants will rate their pain score both during and at 30 seconds after the arterial blood sampling procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The first-attempt success rate for arterial blood sampling procedure when using local anesthesia.	First-attempt success refer to blood sample being successfully drawn from the radial artery at the first trial of skin penetration without needle being withdrawn	During the arterial blood sampling procedure.
explore the relationship between associated factors and overall time for arterial blood draw.	Multivariate linear regression analysis was performed to determine factors associated with time taken for arterial blood draw.	procedure time was recorded since intervention was performed by physician. end point is when physician withdraw an ABG needle from patient skin.

Collaborators and Investigators

• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
• Investigators: Principal Investigator: Chawin Taveekijakarn, MD, QSMVH

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 002/2567

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No