Pharmacodynamics and Pharmacokinetics of Dexmedetomidine in Pediatric

The Safety、Efficacy and Pharmacokinetics of Dexmedetomidine Administered Through Different Routes in Pediatric

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03337581

Enrollment

187

Registered

2017-11-09

Start date

2017-10-20

Completion date

2019-07-31

Last updated

2017-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dexmedetomidine, Pediatrics, Pharmacodynamics, Pharmacokinetics

Keywords

Dexmedetomidine, pediatrics, Pharmacodynamics, Pharmacokinetics

Brief summary

1. Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of Dexmedetomidine in Pediatric. 2. Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric. 3. Pharmacokinetics after a single dose of Dexmedetomidine administered as a nasal spray in Pediatric.

Interventions

DRUGDexmedetomidine

see arms

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 9 Years

Healthy volunteers

Inclusion criteria

* selective operation of inguinal hernia repair、orthopedics operation or general surgery operation in children * aged 3-9 years * ASA I - II * enter the operating room by himself without parents * normal liver and kidney function * no history of anesthesia medication allergy.

Exclusion criteria

* allergic to dexmedetomidine, similar active ingredients or excipients * G-6-PD deficiency * a history of arrhythmia, bronchial and cardiovascular diseases, abnormal liver function and so on * a history of use of alpha 2 receptor agonists or antagonists.

Design outcomes

Primary

Measure	Time frame	Description
Acute Hemodynamic and respiratory Changes After Rapid Intravenous of Dexmedetomidine	up to 4 months	Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of Dexmedetomidine in Pediatric
Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric	up to 6 months	After a single Rapid Intravenous dose of Dexmedetomidine in Pediatric，blood samples will be collected ,and dexmedetomidine plasma concentrations were measured with High Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS).
Pharmacokinetics of Dexmedetomidine administered as a nasal spray	up to 6 months	After a single dose of Dexmedetomidine administered as a nasal spray in Pediatric,blood samples will be collected ,and dexmedetomidine plasma concentrations were measured with High Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS).

Countries

China

Contacts

Primary ContactFang Chen

15254896@qq.com+86 13957776300

Backup ContactChengyu Wang

15158719196@163.com+8615158719196

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026