Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505889
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
The Effect of Local Anesthesia for Pain Reduction During Radial Arterial Puncture in the Emergency Department
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Local Anesthesia for Pain Reduction During Radial Arterial Puncture in the Emergency Department A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Do individuals with prior experience of arterial blood sampling report lower pain scores during and after the procedure compared to those without prior experience
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
Do individuals with prior experience of arterial blood sampling report lower pain scores during and after the procedure compared to those without prior experience
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 -4C 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
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 -4C 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None