NCT03501212

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
1 year until next milestone

Study Start

First participant enrolled

April 27, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

March 21, 2018

Last Update Submit

August 28, 2018

Conditions

Radial Artery Spasm

Outcome Measures

Primary Outcomes (1)

  • Radial pain assessed during artery puncture

    Record pain by visual analog score sub-scale 0(no pain)-10(max pain)

    30 min

Secondary Outcomes (3)

  • Radial pain assessed 30 min after sheath removal

    4 hr post procedure

  • Number of puncture attempts

    imediate post procedure

  • Occurrence of radial artery spasm

    during and post procedure up to 1 years

Study Arms (2)

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

Topical AnestheticDRUG

EMLA Cream 2.5 gr applied to both wrists

Interventional
PlaceboDRUG

Placebo Cream 2.5gr applied to both wrist

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients age \>18 years.
  • Patients who was schedule to performed coronary angiogram

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine

Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Interventions

Anesthetics, Local

Intervention Hierarchy (Ancestors)

AnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Central Study Contacts

Anuwat Rintaravitoon

CONTACT

+66869920022Rintaravitoon@hotmail.com

Nakarin Sansanatudh

CONTACT

+666444755

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2018

First Posted

April 18, 2018

Study Start

April 27, 2019

Primary Completion

June 27, 2019

Study Completion

June 30, 2019

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations

TH(1)