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

Completed

• Conditions: Deep Sedation; Intensive Care Pediatric
• Interventions: Other: PK analysis

• Registration Number: NCT02302391
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-11-27
• Primary Completion: 2018-03
• Study Completion: 2018-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Midazolam/fentanyl: PK analysis	PK analysis	Pediatric intensive care patients under analgosedation with midazolam and fentanyl.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Sedation depth	Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days
Duration of mechanical ventilation	Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany