Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04646135
Status:
UNKNOWN
Last Update Posted:
2020-11-27
First Post:
2020-06-18
Brief Title:
Lorazepam for the Analgosedation of Pediatric Patients in Mechanical Ventilation
Sponsor:
Bambino Gesù Hospital and Research Institute
Organization:
Bambino Gesù Hospital and Research Institute
Study Overview
Official Title:
Not for Profit Monocentric Open Label Trial of Lorazepam Randomized to Three Different Sequences of Boli and Continuous Infusion for Sedation of Children Aged 1 and 12 Years Admitted in Intensive Care and Mechanically Ventilated
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to better define the pharmacokinetic and pharmacodynamic profile of lorazepam for the analgosedation in pediatric intensive care unit This will help to better define the dosages and administration modalities bolus or continue infusion required to achieve analgosedation with lorazepam in pediatric patients undergoing mechanical ventilation
Detailed Description:
The prolonged use of certain sedative drugs such as midazolam whose metabolism is associated with the production of active metabolites can lead to difficult management of sedative therapy and ventilatory weaning The active metabolites whose production is variable determine in fact a difficulty in establishing a precision therapy thus making it necessary to identify new molecules for sedation in pediatric intensive care unit PICU Lorazepam LZ is a benzodiazepine with an intermediate duration of activity administered by continuous infusion or intermittent bolus which has the advantages of higher potency compared to other benzodiazepines a low cost and a metabolism that does not produce active metabolites However the presence of propylene glycol PG an excipient present in intravenous LZ formulations although generally well tolerated is potentially associated with episodes of tissue toxicity due to accumulation phenomena this may represent a risk in cases where LZ is administered in high doses This study based on pharmacokinetic models obtained from data already available in the scientific literature aims to define the pharmacokinetic and pharmacodynamic characteristics of LZ for the analgosedation of pediatric patients admitted to intensive care and subjected to mechanical ventilation Preliminary evaluation of sedative efficacy will be carried out through COMFORT-B scale assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-003901-93 | EUDRACT_NUMBER | None | None |