Population Pharmacokinetics of Propafenone and Propranolol in Children Patients

Shandong University500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Arrhythmia

Interventions

Propafenone and PropranololDRUG

Propafenone Hydrochloride Tablets, 100-200mg, 1 or 2 times per day; Propranolol Hydrochloride Sustained-Release Capsules, 40mg, 1 times per day

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hebei province Children's Hospital

Shijiazhuang, Hebei, China

RECRUITING

Outcomes

Primary Outcomes

Ventricular premature beats of 24 hours

frequency of Ventricular premature beats of 24 hours

Time frame: From date of randomization until the date of discharge, assessed up to 12 months

Secondary Outcomes

P-R interval

P-R interval time

Time frame: From date of randomization until the date of discharge, assessed up to 12 months

QT interval

QT interval time

Time frame: From date of randomization until the date of discharge, assessed up to 12 months

Data from ClinicalTrials.gov

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