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

NCT ID: NCT03501212

Last Updated: 2018-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-27

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Radial Artery Spasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Interventional

EMLA group layer of 2.5 gr EMLA cream (standard adult dose) was applied to both wrists

Group Type ACTIVE_COMPARATOR

Topical Anesthetic

Intervention Type DRUG

EMLA Cream 2.5 gr applied to both wrists

Placebo

Placebo cream was applied to both wrists

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Cream 2.5gr applied to both wrist

Interventions

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Topical Anesthetic

EMLA Cream 2.5 gr applied to both wrists

Intervention Type DRUG

Placebo

Placebo Cream 2.5gr applied to both wrist

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Internal Medicine

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Anuwat Rintaravitoon

Role: CONTACT

+66869920022

Nakarin Sansanatudh

Role: CONTACT

+666444755

Facility Contacts

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Anuwat Rintaravitoon, MD

Role: primary

+66869920022 ext. 33334

Nakarin Sansanayudh, MD,Phd

Role: backup

+6623547600 ext. 93827

Other Identifiers

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PMK-2018

Identifier Type: -

Identifier Source: org_study_id

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