Effect of Topical Anesthesia on Patient's Pain Discomfort... | NCT03501212

Studies
Effect of Topical Anesthesia on Patient's Pain Discomfort and Radial Artery Spasm in Transradial Catheterization

NCT03501212

Sponsor

Phramongkutklao College of Medicine and Hospital

Status

Unknown status

Last Update Posted

Aug 29, 2018Actual

Enrollment

120Estimated

Phase

Phase 4

Conditions

Radial Artery Spasm

Interventions

Topical Anesthetic
Placebo

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 27, 2019Estimated

Primary Completion Date

Jun 27, 2019Estimated

Completion Date

Jun 30, 2019Estimated

First Submitted Date

Mar 21, 2018

First Submission Date that Met QC Criteria

Apr 16, 2018

First Posted Date

Apr 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2018

Last Update Posted Date

Aug 29, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventional	Active Comparator	EMLA group layer of 2.5 gr EMLA cream (standard adult dose) was applied to both wrists	Drug: Topical Anesthetic
Placebo	Placebo Comparator	Placebo cream was applied to both wrists	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Topical Anesthetic	Drug	EMLA Cream 2.5 gr applied to both wrists	Interventional

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radial pain assessed during artery puncture	Record pain by visual analog score sub-scale 0(no pain)-10(max pain)	30 min

Secondary Outcomes

Measure	Description	Time Frame
Radial pain assessed 30 min after sheath removal	Record pain by visual analog score	4 hr post procedure
Number of puncture attempts	Number of puncture attempts

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anuwat Rintaravitoon	Contact	+66869920022		Rintaravitoon@hotmail.com
Nakarin Sansanatudh	Contact	+666444755

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Internal Medicine	Recruiting	Bangkok		10400	Thailand

Intervention Browse Module

MeSH Terms

ID	Term
D000779	Anesthetics, Local

Ancestor Terms

ID	Term
D000777	Anesthetics
D002492	Central Nervous System Depressants
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Browse Leaves

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Browse Branches

Not provided