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NCT Number: NCT02302391

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.

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Key information

Conditions

Deep Sedation Intensive Care Pediatric

Age range

28 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PK analysis

Other

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

Primary outcomes

  1. Plasma levels of midazolam, 1'-Hydroxymidazolam and fentanyl and resulting pharmacokinetic parameters

    Time frame: Once daily during analgosedation [expected average of 10 days) and 0, 1, 2, and 4h after stopping of midazolam

Secondary outcomes

  1. Duration of mechanical ventilation

    Time frame: Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days

  2. Sedation depth

    Time frame: Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days

  3. Length of stay at the intensive care unit (ICU)

    Time frame: Participants will be followed for the duration of stay at the ICU, an expected average of 3 weeks

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: Morpheus

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 27, 2014
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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