Effect of Topical Anesthesia on Patient's Pain Discomfort and Radial Artery Spasm in Transradial Catheterization
Primary Purpose
Radial Artery Spasm
Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Topical Anesthetic
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Radial Artery Spasm
Eligibility Criteria
Inclusion Criteria:
- Patients age >18 years.
- Patients who was schedule to performed coronary angiogram
Exclusion Criteria:
Previous ipsilateral transradial approach Raynaud's syndrome ESRD History of sensitivity to local anesthetics Non-palpable redial pulse Abnormal Barbeau's test Local site infection Patient's refusal
Sites / Locations
- Department of Internal MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Interventional
Placebo
Arm Description
EMLA group layer of 2.5 gr EMLA cream (standard adult dose) was applied to both wrists
Placebo cream was applied to both wrists
Outcomes
Primary Outcome Measures
Radial pain assessed during artery puncture
Record pain by visual analog score sub-scale 0(no pain)-10(max pain)
Secondary Outcome Measures
Radial pain assessed 30 min after sheath removal
Record pain by visual analog score
Number of puncture attempts
Number of puncture attempts
Occurrence of radial artery spasm
NuNumber of radial artery spasm
Full Information
NCT ID
NCT03501212
First Posted
March 21, 2018
Last Updated
August 28, 2018
Sponsor
Phramongkutklao College of Medicine and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03501212
Brief Title
Effect of Topical Anesthesia on Patient's Pain Discomfort and Radial Artery Spasm in Transradial Catheterization
Official Title
Effect of Topical Anesthesia on Patient's Pain Discomfort and Radial Artery Spasm in Transradial Catheterization
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 27, 2019 (Anticipated)
Primary Completion Date
June 27, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phramongkutklao College of Medicine and Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluate topical anaesthesia application for 30 minutes before tranradial catheterization during cardiac catheterization can reduce pain and decrease radial artery spasm
Detailed Description
The incidence of Radial artery spasm (RAS) has varied from 5-30% RAS refers to friction between the artery and wires or guide catheters accompanied by a subjective feeling of pain.
EMLA anesthetic ointment (AO-Astra Zeneca) is an emulsion of lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight Previous study showed that EMLA cream can increase the success rate of femoral cannulation in children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radial Artery Spasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Active Comparator
Arm Description
EMLA group layer of 2.5 gr EMLA cream (standard adult dose) was applied to both wrists
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo cream was applied to both wrists
Intervention Type
Drug
Intervention Name(s)
Topical Anesthetic
Intervention Description
EMLA Cream 2.5 gr applied to both wrists
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Cream 2.5gr applied to both wrist
Primary Outcome Measure Information:
Title
Radial pain assessed during artery puncture
Description
Record pain by visual analog score sub-scale 0(no pain)-10(max pain)
Time Frame
30 min
Secondary Outcome Measure Information:
Title
Radial pain assessed 30 min after sheath removal
Description
Record pain by visual analog score
Time Frame
4 hr post procedure
Title
Number of puncture attempts
Description
Number of puncture attempts
Time Frame
imediate post procedure
Title
Occurrence of radial artery spasm
Description
NuNumber of radial artery spasm
Time Frame
during and post procedure up to 1 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients age >18 years.
Patients who was schedule to performed coronary angiogram
Exclusion Criteria:
Previous ipsilateral transradial approach Raynaud's syndrome ESRD History of sensitivity to local anesthetics Non-palpable redial pulse Abnormal Barbeau's test Local site infection Patient's refusal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anuwat Rintaravitoon
Phone
+66869920022
Email
Rintaravitoon@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nakarin Sansanatudh
Phone
+666444755
Facility Information:
Facility Name
Department of Internal Medicine
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anuwat Rintaravitoon, MD
Phone
+66869920022
Ext
33334
Email
Rintaravitoon@hotmail.com
First Name & Middle Initial & Last Name & Degree
Nakarin Sansanayudh, MD,Phd
Phone
+6623547600
Ext
93827
Email
dr_nakarin@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Topical Anesthesia on Patient's Pain Discomfort and Radial Artery Spasm in Transradial Catheterization
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