To acquire more insight in the relation between age and pharmacodynamics and more insight in the relation between age and pharmacokinetics of midazolam in children.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
betreft kinderen opgenomen op een kinder intensive care afdeling met een diversiteit aan aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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 outcome
not applicable.
Background summary
Adequate sedation is an important aspect of care in a Paediatric Intensive Care
Unit (PICU). Midazolam is the most widely used sedative agent in critically ill
children. Retrospective study shows that midazolam requirements in the PICU are
age-related. Prospective studies that investigate this age-related effect in
pharmacodynamics of midazolam are lacking. A possible explanation of the
age-related variation in sedative effect of midazolam might be found in
age-related pharmacokinetic differences
Study objective
To acquire more insight in the relation between age and pharmacodynamics and
more insight in the relation between age and pharmacokinetics of midazolam in
children.
Study design
Prospective, observational study, at the PICU and Clinical Pharmacology and
Pharmacy, VUmc Amsterdam.
Methods: Demographic data and routinely acquired laboratorial data will be
collected of each included patient. Also the total dose of midazolam in
milligrams per kilograms per day will be registered. During the first three
days after acquiring informed consent, three times a day at fixed hours and
when changing the midazolam dosage, a blood sample of ca. 1 ml (max. 2 ml if
possible) will be taken. Also while running down the midazolam dosage, blood
samples (max. 3 of ca. 1 ml with an interval of ca. 3 hours) will be taken. In
the blood samples the concentration of midazolam and her metabolites will be
determined. Before each blood taking, the COMFORT-B-score, that measures the
depth of sedation, will be determined.
Study burden and risks
The extra burden for the patient is the taking of max. 15 ml of blood via the
already existing artery line or central venous line. This means the patient
won*t be pricked for this study alone. All the time the amount of blood that is
taken will be checked, especially in the youngest children. The actions that
are undertaken in this study belong to the normal health care that is provided
to all admitted children
Postbus 7057
1007 MB
Nederland
Postbus 7057
1007 MB
Nederland
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL16584.029.07 |