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Pharmacokinetics of Lorazepam Oral Liquid in Paediatric ICU Patients


- candidate number21838
- NTR NumberNTR5112
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mrt-2015
- Secondary IDs2015-001043-37 LORA01
- Public TitlePharmacokinetics of Lorazepam Oral Liquid in Paediatric ICU Patients
- Scientific TitlePharmacokinetics of Lorazepam Oral Liquid in Paediatric ICU Patients Improving the weaning guideline at the Paediatric ICU
- ACRONYMPK of Lorazepam Oral Liquid in PICU Patients
- hypothesis
- Healt Condition(s) or Problem(s) studiedCritically ill children, Sedation, Oral
- Inclusion criteriaage 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 criteriaconcomitant 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-aug-2015
- planned closingdate1-aug-2016
- Target number of participants20
- InterventionsI.V. and oral administration of lorazepam
- Primary outcomePK parameters
- Secondary outcomeinfluence of co-variates
- Timepoints48 hrs
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESPh.D, Pharm.D L. Hanff
- CONTACT for SCIENTIFIC QUERIESDr. L.M. Hanff
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD23-mrt-2015 - 14-jul-2015


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