Pharmacokinetics of Lorazepam Oral Liquid in Paediatric ICU Patients

Pharmacokinetics of Lorazepam Oral Liquid in Paediatric ICU Patients Improving the weaning guideline at the Paediatric ICU

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24356

Enrollment

Registered

2015-03-23

Start date

2015-08-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

PICU, sedation, weaning, withdrawal, IC kinderen, ontwenning, sedatie, afbouwen, oraal

Interventions

I.V. and oral administration of lorazepam

Eligibility

Inclusion criteria

Inclusion criteria: age between 2 weeks and 12 years, signed consent from the parent or legal assent, admitted to the paediatric ICU, indwelling intravenous or arterial catheter, scheduled to start the weaning protocol with oral lorazepam.

Exclusion criteria

Exclusion criteria: concomitant treatment with another investigational drug, contraindications for lorazepam use; Severe liver insufficiency, defined as 5 times upper level of ALAT and ASAT Hypersensitivity to lorazepam, Myasthenia gravis.

Design outcomes

Primary

Measure	Time frame
PK parameters	—

Secondary

Measure	Time frame
influence of co-variates	—

Contacts

Public ContactL. Hanff

l.hanff@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)