Pharmacokinetic Analysis of Midazolam and Fentanyl in Pediatric Patients With Long-term Analgosedation (Morpheus)

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Deep Sedation; Intensive Care Pediatric

Treatments: Other: PK analysis

Study type: Observational

Funder types: Other

Identifiers

NCT02302391

PV4546

Details and patient eligibility

About

Pharmacokinetic monitoring of midazolam, it's active metabolite and fentanyl in pediatric patients with long-term analgosedation will be performed. Especially, the chronologic sequence of the quantified plasma levels during sedation and during wake-up as well as the correlation to dose and sedation depth will be focused.

Full description

At pre-defined timepoints (see below) serum Levels of the above mentioned drugs and metabolites will be determined and pharmakokinetic (PK) modeling will be performed. PK data will be correlated to sedation depth, as assessed using a validated score.

Three Age Groups (infants, children and adolescents) will be evaluated considering the physiologic properties during pediatric development.

Enrollment: 25 patients

Sex: All

Ages: 28 days to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pediatric patients between 28 days and 17 years of age
• mechanical ventilation more than 3 days
• analgosedation with midazolam and fentanyl

Exclusion criteria

• missing informed consent

Trial design

25 participants in 1 patient group

Midazolam/fentanyl: PK analysis

Description:

Pediatric intensive care patients under analgosedation with midazolam and fentanyl.

Treatment:

Other: PK analysis