Therapeutic Drug Monitoring of Anxiolytics in Children

Phase 4

• Conditions: Anxiolytics
• Interventions: Drug: Midazolam/diazepam/propofol

• Registration Number: NCT03960671
• Lead Sponsor: Wei Zhao

Brief Summary

In this study, the therapeutic drug monitoring of anxiolytics is carried out among children to obtain the drug concentration, clinical efficacy and safety data of children patients in different gender and age groups. Then the investigators analyze the relationship between blood drug concentration and efficacy and safety, and provide recommendations for the treatment window of anxiolytics in Chinese children.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-04-27
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-21
• Last Update Submitted: 2019-05-21
• Study First Posted: 2019-05-23
• Last Update Posted: 2019-05-23
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

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

Inclusion Criteria

• Anxiolytics was used for therapeutic purposes;
• Age:≤18 years;
• Patients with therapeutic concentration monitoring of anxiolytics.

Exclusion Criteria

• Patients without therapeutic concentration monitoring of anxiolytics;
• The blood concentrations of the patient was not approved by the quality control center
• Use foods or products that inhibit or induce CYP 3A activity.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anxiolytics	Midazolam/diazepam/propofol	Pediatric patients treated with sedation using anxiolytics

Primary Outcome Measures

Name	Time	Method
Plasma drug concentration	Through study completion, an average of 14 days	To detect the plasma concentrations of teicoplanin at therapeutic drug monitoring (TDM).

Trial Locations

Locations (1)

Shandong Provincial Qianfoshan Hospital; 🇨🇳 Ji'nan, Shandong, China