Population Pharmacokinetics of Propafenone and Propranolol in Children Patients

Recruiting

• Conditions: Arrhythmia

• Registration Number: NCT05463614
• Lead Sponsor: Shandong University

Brief Summary

The use of propafenone and propranolol in children during clinical treatment was depending mostly on experience. Besides, there was no recommended dose for children in drug instruction. Therefore, the investigators' aim is to study the pharmacokinetics and pharmacodynamics in children.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-17
• Last Update Submitted: 2022-07-17
• Study First Posted: 2022-07-19
• Last Update Posted: 2022-07-19
• Primary Completion: 2022-08-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients aged ≤18years. Parental written consent to participate in the study. Patients treat with Propafenone and Propranolol

Exclusion Criteria

• Patients can not complete the research; Abnormal hepatic and renal function; Patient is allergic to propafenone; There are conditions that researchers do not consider it appropriate to join the research.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventricular premature beats of 24 hours	From date of randomization until the date of discharge, assessed up to 12 months	frequency of Ventricular premature beats of 24 hours

Secondary Outcome Measures

Name	Time	Method
P-R interval	From date of randomization until the date of discharge, assessed up to 12 months	P-R interval time
QT interval	From date of randomization until the date of discharge, assessed up to 12 months	QT interval time

Trial Locations

Locations (1)

Hebei province Children's Hospital; 🇨🇳 Shijiazhuang, Hebei, China