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

Deep Sedation Clinical Trial

— Morpheus  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302391
• Other study ID #: PV4546
• Status: Completed
• Start date: October 2014
• Est. completion date: October 2018

Study information

• Verified date: April 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Sedation
• Intensive Care Pediatric

Intervention

Other:
• PK analysis
Quantification of Serum Levels and subsequent pharmacokinetic (PK) modelling.

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of mechanical ventilation		Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days
Secondary	Sedation depth		Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days
Secondary	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