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A population pharmacokinetic study of S(+)-ketamine in children

A population pharmacokinetic study of S(+)-ketamine in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066077
Enrollment
Unknown
Registered
2022-11-23
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Population pharmacokinetics of S(+)-ketamine in children

Interventions

A:0.5mg/kg of S(+)-ketamine was injected intravenously, and 1ml of arterial blood was collected at 1min, 20min and 4h after drug administration
B:0.5mg/kg of S(+)-ketamine was injected intravenously, and 1ml of arterial blood was collected at 2min, 30min and 6h after drug administration
C:0.5mg/kg of S(+)-ketamine was injected intravenously, and 1ml of arterial blood was collected at 4min, 1h and 8h after drug administration
D:0.5mg/kg of S(+)-ketamine was injected intravenously, and 1ml of arterial blood was collected before, 6min, 1.5h and 12h after drug administration
E:0.5mg/kg of S(+)-ketamine was injected intravenously, and 1ml of arterial blood was collected immediately, 10min, 2h and 24h after drug administration

Sponsors

The Children's Hospital of ZheJiang University of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 12 Years

Inclusion criteria

Inclusion criteria: (1) American Society of Anesthesiologists (ASA) patient classification I-II. (2) Normal liver and kidney function. (3) No tumor, hematologic, immunologic, or metabolic system disease. (4) Need to be admitted to ICU with a tube.

Exclusion criteria

Exclusion criteria: (1) Bilateral urinary tract obstruction. (2) Hypoproteinemia. (3) Patients on recent liver drug enzyme inhibitors/inducers.

Design outcomes

Primary

MeasureTime frame
Blood concentration of S(+)-ketamine;Blood concentration of S(+)-norketamine;Hepatocyte cytochrome P450 enzyme genotype(CYP2B6?CYP3A4?CYP2E1?CYP2A6?CPY2C9);NMDA receptor-related genotypes (GRIN2B, GRIN1, GRIN2A);

Secondary

MeasureTime frame
Blood pressure;Heart rate;Breathing rate;Oxygen saturation;

Countries

China

Contacts

Public ContactYaoqin Hu

The Children’s hospital of ZheJiang University School of Medicine

huyaoqin@zju.edu.cn15167112579

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026