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Therapeutic Drug Monitoring of Anxiolytics in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03960671
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Information provided by (Responsible Party):
Wei Zhao, Shandong University

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.

Condition or disease Intervention/treatment Phase
Anxiolytics Drug: Midazolam/diazepam/propofol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Therapeutic Drug Monitoring of Anxiolytics in Children
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Diazepam

Arm Intervention/treatment
Experimental: Anxiolytics
Pediatric patients treated with sedation using anxiolytics
Drug: Midazolam/diazepam/propofol
Therapeutic drug monitoring of anxiolytics

Primary Outcome Measures :
  1. Plasma drug concentration [ Time Frame: Through study completion, an average of 14 days ]
    To detect the plasma concentrations of teicoplanin at therapeutic drug monitoring (TDM).

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03960671

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Contact: Zhao Wei, Ph.D 86053188383308

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China, Shandong
Shandong Provincial Qianfoshan Hospital Recruiting
Ji'nan, Shandong, China, 250014
Contact: Zhao Wei, Ph.D.    86053188383308   
Sponsors and Collaborators
Wei Zhao

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Responsible Party: Wei Zhao, Professor; Head of department of clinical pharmacy and pharmacology, Shandong University Identifier: NCT03960671     History of Changes
Other Study ID Numbers: 2019-anxiolytics-001
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anti-Anxiety Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Adjuvants, Anesthesia
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Muscle Relaxants, Central
Neuromuscular Agents