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

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

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.

Study Overview

• Status: Completed
• Conditions: Deep Sedation; Intensive Care Pediatric
• Intervention / Treatment: Other: PK analysis

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pediatric patients with long-term analgosedation at the Pediatric Intensive Care Unit of the University Medical Center Hamburg-Eppendorf.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Midazolam/fentanyl: PK analysis; Pediatric intensive care patients under analgosedation with midazolam and fentanyl.	Other: PK analysis; Quantification of Serum Levels and subsequent pharmacokinetic (PK) modelling.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Dominique Singer, Prof. Dr., University Medical Center Hamburg-Eppendorf, Department of Pediatrics

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: November 24, 2014
• First Submitted That Met QC Criteria: November 26, 2014
• First Posted (Estimate): November 27, 2014

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PV4546