Therapeutic Drug Monitoring of Anxiolytics in Children

Wei Zhao

Status and phase: Unknown; Phase 4

Conditions: Anxiolytics

Treatments: Drug: Midazolam/diazepam/propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT03960671

2019-anxiolytics-001

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 29 days to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Anxiolytics

Experimental group

Description:

Pediatric patients treated with sedation using anxiolytics

Treatment:

Drug: Midazolam/diazepam/propofol