Pain ControlNCT06505889
Comparison of Low-cost Interventions for Pain Reduction During Radial Artery Puncture in the Emergency Department: A Three-arm Randomized Controlled Trial
A study testing Local anesthesia methods in people with Pain Control, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Control
- What is being tested?
- Local anesthesia methods
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read the 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.
- Conditions
- Pain Control
- Being tested
- Local anesthesia methods
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthesia methodsOther
Local pain control method before arterial blood sampling procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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.
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
Measured: 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.
Measured: procedure time was recorded since intervention was performed by physician. end point is when physician withdraw an ABG needle from patient skin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Jul 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chawin Taveekijakarn, MD, Principal investigator, QSMVH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505889
- Sponsor's protocol ID
- 002/2567
- Status last verified
- May 2025
- First submitted
- 1 Jul 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Low-cost Interventions for Pain Reduction During Radial Artery Puncture in the Emergency Department: A Three-arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06505889
- Acronym / sponsor ID
- 002/2567
- Conditions
- Pain Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Cryo-analgesic group (Ice pack) | Experimental | Other: Local anesthesia methodsA 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. |
| Analgesic drug group (10% lidocaine spray) | Experimental | Other: Local anesthesia methods10% 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local anesthesia methodsLocal pain control method before arterial blood sampling procedure | Other | Analgesic drug group (10% lidocaine spray), Cryo-analgesic group (Ice pack) |
Primary outcome
Pain score both during and after the arterial blood sampling procedure.
Time frame: Participants will rate their pain score both during and at 30 seconds 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."
2 secondary outcomes
The first-attempt success rate for arterial blood sampling procedure when using local anesthesia.
Time frame: During the arterial blood sampling procedure.
explore the relationship between associated factors and overall time for arterial blood draw.
Time frame: procedure time was recorded since intervention was performed by physician. end point is when physician withdraw an ABG needle from patient skin.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chawin Taveekijakarn, MD principal investigator
QSMVH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anesthesia methods in people with Pain Control, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score both during and after the arterial blood sampling procedure. (time frame: Participants will rate their pain score both during and at 30 seconds after the arterial blood sampling procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.