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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON31394
Enrollment
28
Registered
2007-07-23
Start date
2007-04-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

betreft kinderen opgenomen op een kinder intensive care afdeling met een diversiteit aan aandoeningen sleep medication

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
- Mean daily dosage of midazolam per day will be comapred between different ages (Kruskall Wallis test). - Analysis of pharmacokinetics (plasma concentrations) and pharmacodynamics (Comfort-B score) with the NON-linear Mixed Effect Modelling (NONMEM).

Secondary

MeasureTime frame
not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)