Age dependency of midazolam requirements in a pediatric intensive care unit: a prospective clinical study

• Conditions: betreft kinderen opgenomen op een kinder intensive care afdeling met een diversiteit aan aandoeningen; sleep medication

• Registration Number: NL-OMON31394
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

All children, age between 0-12 years, being admitted between July 2007 and July 2008 to the pediatric intensive care unit and to be expected being mechanically ventilated for 48 h and permesiion obtained within 24 h after admission.

Exclusion Criteria

If midazolam is not the first line drug for sedation. Use of midazolam as anti-epileptic medication. No arteila line or central venous line present. Known liver or renal function disorders or head trauma or psychomotoric retardation.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Mean daily dosage of midazolam per day will be comapred between different ages<br /><br>(Kruskall Wallis test).<br /><br><br /><br>- Analysis of pharmacokinetics (plasma concentrations) and pharmacodynamics<br /><br>(Comfort-B score) with the NON-linear Mixed Effect Modelling (NONMEM).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable.</p><br>