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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

About this trial

This is an interventional treatment trial for Radial Artery Spasm

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Studies a U.S. FDA-regulated Device Product

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

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

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

Rintaravitoon@hotmail.com

First Name & Middle Initial & Last Name & Degree

Nakarin Sansanayudh, MD,Phd

Phone

+6623547600

Ext

93827

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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