No registrations found.
ID
NL-OMON24356
Source
NTR
Brief title
PK of Lorazepam Oral Liquid in PICU Patients
Health condition
PICU, sedation, weaning, withdrawal, IC kinderen, ontwenning, sedatie, afbouwen, oraal
Sponsors and support
Primary sponsor
:
Erasmus MC
Source(s) of monetary or material Support
:
ZonMW
Intervention
Outcome measures
Primary outcome
PK parameters
Secondary outcome
influence of co-variates
Study design
48 hrs
Intervention
I.V. and oral administration of lorazepam
Public
L. Hanff
Hospital Pharmacy Erasmus MC
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
l.hanff@erasmusmc.nl
Hospital Pharmacy Erasmus MC
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
l.hanff@erasmusmc.nl
Scientific
L. Hanff
Hospital Pharmacy Erasmus MC
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
l.hanff@erasmusmc.nl
Hospital Pharmacy Erasmus MC
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
l.hanff@erasmusmc.nl
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
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
Study type
:
Interventional
Intervention model
:
Crossover
Allocation
:
Non controlled trial
Masking
:
Open (masking not used)
Control
:
Active
Recruitment
NL
Recruitment status
:
Pending
Start date (anticipated)
:
Enrollment
:
20
Type
:
Anticipated
Positive opinion
Date
:
Application type
:
First submission
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 |
|---|---|
| NTR-new | NL4974 |
| NTR-old | NTR5112 |
| Other | LORA01 : 2015-001043-37 |