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

NCT06505889 | Completed DMC

• 1 other identifier: 002/2567
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Pain Control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The first-attempt success rate for arterial blood sampling procedure when using local anesthesia.

  During the arterial blood sampling procedure.

• explore the relationship between associated factors and overall time 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.

Study Arms (3)

Cryo-analgesic group (Ice pack)

EXPERIMENTAL

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

Analgesic drug group (10% lidocaine spray)

EXPERIMENTAL

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

Control group (2% Chlorhexidine alcohol)

NO INTERVENTION

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.

Interventions

Local anesthesia methods OTHER

Local pain control method before arterial blood sampling procedure

Analgesic drug group (10% lidocaine spray); Cryo-analgesic group (Ice pack)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Queen Savang Vadhana Memorial Hospital

Chon Buri, 20110, Thailand

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chawin Taveekijakarn, MD

  QSMVH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to one of three study groups (A, B, or C) to receive different local anesthesia methods prior to arterial blood sampling: Group A (Ice pack), Group B (10% lidocaine spray), Group C (Control)

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 17, 2024
• Study Start: July 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

TH (1)