Trials / Completed
CompletedNCT02302391
Pharmacokinetic Analysis of Midazolam and Fentanyl in Pediatric Patients With Long-term Analgosedation
Pharmacokinetic Analysis of Midazolam and Fentanyl in Pediatric Patients With Long-term Analgosedation.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (actual)
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf · Academic / Other
- Sex
- All
- Age
- 28 Days – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | PK analysis | Quantification of Serum Levels and subsequent pharmacokinetic (PK) modelling. |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2018-03-01
- Completion
- 2018-10-01
- First posted
- 2014-11-27
- Last updated
- 2021-04-30
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02302391. Inclusion in this directory is not an endorsement.