The Use of Antiarrhythmic Drugs in Pediatrics

February 20, 2024 updated by: Reham Abdel-Aziz mohamed, Assiut University

Clinical Audit on the Use of Antiarrhythmic Drugs in Pediatric Age Group

A study on the use of antiarrhythmic drugs in pediatric age group, in Assiut University Children's Hospital, a clinical audit

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Arrhythmias occur in children and adolescents with congenital heart disease as well as those with structurally normal hearts.

Rhythm disturbances (arrhythmias) are not uncommon in sick children admitted in pediatric intensive care unit. These occur as a result of abnormalities in, or insults to, the cardiac conduction system or heart tissues. A rhythm disturbance in a child should be treated as life threatening emergency.

The generation of the action potential and the regional differences that are observed throughout the heart are the result of the selective permeability of ion channels distributed on the cell membrane.

Abnormalities in surface membrane ion channel function are central to arrhythmogenesis.

Antiarrhythmic medications primarily affect the ion channels in cardiac myocytes that are responsible for generating currents that create the action potential.

By altering the activity of these ion channels, the action potential is changed to reduce the likelihood of sustained arrhythmias.

These drugs are predominantly used in treatment of arrhythmia but in addition they are also used as a treatment of other cardiac and non-cardiac conditions.

For example, Calcium channel blockers have been one of the most widely used classes of antihypertensive agents in the last 20 years.

Carvedilol (a beta blocker agent) can be safely used for treatment of chronic heart dysfunction in pediatric patients with dilated cardiomyopathy.

β-blockers are also an essential component of pharmacologic therapy for children with congestive heart failure.

There is a wide range of antiarrhythmic drugs used in treatment of arrhythmias. The modernized comprehensive classification of both established and potential antiarrhythmic drugs was proposed in 2018 Class 0: HCN channel-mediated pacemaker current (If) block Class I: Antiarrhythmic that affect sodium channels (slow depolarization) Class II: Drugs that counteract the sympathetic nervous system, predominantly beta-blockers Class III: drugs that affect the potassium channels (prolong repolarization) Class IV: Drugs that affect calcium channels (Calcium channel blockers) Class V: mechanically sensitive ion channels, Mechanosensitive channel blockers Class VI: Gap junction channel blockers Class VII: Upstream target modulators.

In this study the aim is to describe the use of Cardiovascular Drugs in Pediatric Cardiology unit Assiut University. As regard: indications of use, proper dosage and proper management of side effects of their use.

Study Type

Observational

Enrollment (Estimated)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Reham Abdel-Aziz Mohamed, Resident doctor
  • Phone Number: +201098345222
  • Email: rema31997@gmail.com

Study Contact Backup

  • Name: Salah-Eldin Amry, professor
  • Phone Number: +201146082024
  • Email: S_amry@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All Patients with Arrhythmic cardiac diseases admitted at cardiology unit Assiut University Hospital aged from 1 month to 18 years.

Description

Inclusion Criteria:

  • All Patients with Arrhythmic cardiac diseases admitted at cardiology unit Assiut University Hospital aged from 1 month to 18 years.
  • All patient receiving antiarrhythmic drugs admitted to Assiut University Hospital for Children.

Exclusion Criteria:

• Any patient on drugs other than antiarrhythmics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detect the rate of use of antiarrhythmic drugs in pediatrics and the different indications for them other than the control of arrhythmia.
Time Frame: Baseline
A study on the use of antiarrhythmic drugs in pediatric age group, in Assiut University Children's Hospital and the different indications for them other than the control of arrhythmia
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

November 23, 2023

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Actual)

February 22, 2024

Study Record Updates

Last Update Posted (Actual)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Antiarrhythmic drugs

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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