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

Pharmacokinetic Analysis of Midazolam and Fentanyl in Pediatric Patients With Long-term Analgosedation.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02302391

Acronym

Morpheus

Enrollment

Registered

2014-11-27

Start date

2014-10-31

Completion date

2018-10-31

Last updated

2021-04-30

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

Conditions

Deep Sedation, Intensive Care Pediatric

Brief summary

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.

Detailed 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.

Interventions

OTHERPK analysis

Quantification of Serum Levels and subsequent pharmacokinetic (PK) modelling.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

28 Days to 17 Years

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

Design outcomes

Primary

Measure	Time frame
Plasma levels of midazolam, 1'-Hydroxymidazolam and fentanyl and resulting pharmacokinetic parameters	Once daily during analgosedation [expected average of 10 days) and 0, 1, 2, and 4h after stopping of midazolam

Secondary

Measure	Time frame
Duration of mechanical ventilation	Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days
Sedation depth	Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days
Length of stay at the intensive care unit (ICU)	Participants will be followed for the duration of stay at the ICU, an expected average of 3 weeks

Countries

Germany

Outcome results

None listed

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