Lorazepam for the Analgosedation of Pediatric Patients in Mechanical Ventilation.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Analgesia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Arm I: Day 1: 6 Boluses at 0.1 mg/kg LZ every 4 hr Day 2: 6 Boluses at 0.2 mg/kg LZ every 4 hr Day 3: Continuous Infusion at 0.025 mg/kg/hr LZ Arm II: Day 1: 6 Boluses at 0.2 mg/kg LZ every 4 hr Day 2: 6 Boluses at 0.1 mg/kg LZ every 4 hr Day 3: Continuous Infusion at 0.03 mg/kg/hr LZ Arm III: Day 1: 6 Boluses at 0.3 mg/kg LZ every 4 hr Day 2: 6 Boluses at 0.1 mg/kg LZ every 4 hr Day 3: Continuous Infusion at 0.025 mg/kg/hr LZ Patients will be monitored for further 3 days of follow-up, after the end of the administration sequence. In case they would still need to undergo analgosedation, other drugs will be administered (e.g. midazolam, dexmedetomidine). Patients will also be divided into two age groups - 6 patients: age ?1 year <5 years (COHORT 1); 3 patients: age ?5 years - <12 years (COHORT 2)Masking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 1 years and 11 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04646135
- Collaborators
- Ministero della Salute, Italy
- University College, London
- Investigators
- Principal Investigator: Marco Marano, MD Bambino Gesù Hospital and Research Institute
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