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

NCT02302391 | Completed

• 1 other identifier: PV4546
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Sedation; Intensive Care Pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Midazolam/fentanyl: PK analysis

Pediatric intensive care patients under analgosedation with midazolam and fentanyl.

Other: PK analysis

Interventions

PK analysis OTHER

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

Midazolam/fentanyl: PK analysis

Eligibility Criteria

• Age: 28 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• missing informed consent

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Study Officials

• Dominique Singer, Prof. Dr.

  University Medical Center Hamburg-Eppendorf, Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Section Neonatology and Pediatric Intensive Care, University Medical Center Hamburg-Eppendorf

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 27, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: October 1, 2018
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

DE (1)