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
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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shandong Provincial Qianfoshan Hospital
🇨🇳Ji'nan, Shandong, China