Pharmacokinetics and pharmacodynamics of esketamine during longterm sedation of children at the intensive care

Pharmacokinetics and pharmacodynamics of esketamine during longterm sedation of children at the intensive care - PK - PD of esketamine during sedation of children

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35741

Enrollment

Registered

2011-11-03

Start date

2011-09-19

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Sedatie bij intubatie tbv beademing sedation

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Sedation with ketamine and lorazepam with protocol: Sedation and analgesia during artificial respiration > 1 week 2. Presence of an arterial or central line for blood sampling 3. Presence of an Informed Consent

Exclusion criteria

Exclusion criteria: 1. A contra indication for the use of ketamine: ** Increased intracranial pressure leading to serious risks. ** Hypersensitivity for the farmacon 2. Absence of Informed Consent

Design outcomes

Primary

Measure	Time frame
1. The PK parameters of esketamine; clearance, distributionvolume and half life. 2.The PD parameters of esketamine; EC50 (concentration at half Emax) and Emax (maximal effect). These parameters characterize the relationship between plasmaconcentration of esketamine and the sedative effect (COMFORT-B score).	—

Secondary

Measure	Time frame
Inter- and intra-patient variability of the PK and PD parameters of esketamine.	—

Countries

Netherlands

Outcome results