Status:

COMPLETED

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

Lead Sponsor:

Universitätsklinikum Hamburg-Eppendorf

Conditions:

Deep Sedation

Intensive Care Pediatric

Eligibility:

All Genders

28-17 years

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 quantifi...

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 se...

Eligibility Criteria

Inclusion

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

Exclusion

  • missing informed consent

Key Trial Info

Start Date :

October 1 2014

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 1 2018

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT02302391

Start Date

October 1 2014

End Date

October 1 2018

Last Update

April 30 2021

Active Locations (1)

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1

University Medical Center Hamburg-Eppendorf

Hamburg, Germany, 20246