Trial intelligence / Profile preview

Lorazepam PK/PD for Sedation in Pediatric ICU

NCT04646135Phase 2

Key facts

Status: Unknown
Start: Dec 2020
Primary completion: Jul 2021
Modality: Small Molecules

Drugs: lorazepam
Conditions: sedation

Overview

Phase 2, randomised, open-label trial of lorazepam in sedation (3 arms). Primary endpoint: Lorazepam Pharmacokinetics (AUC) at 72 hours. Status: unknown.

Design

3 arms

Study design: RandomizedOpen-label

Sequence 1
Day 1: 6 Boluses 0.1 mg/kg; Day 2: 6 Boluses 0.2 mg/kg; Day 3: Continuous Infusion 0.025 mg/kg/h
Sequence 2
Day 1: 6 Boluses 0.2 mg/kg; Day 2: 6 Boluses 0.1 mg/kg; Day 3: Continuous Infusion 0.03 mg/kg/h
Sequence 3
Day 1: 6 Boluses 0.3 mg/kg; Day 2: 6 Boluses 0.1 mg/kg; Day 3: Continuous Infusion 0.025 mg/kg/h

Who it enrols

Critically ill children aged 1 to <12 years requiring mechanical ventilation and sedation in PICU. Excludes patients with severe renal, liver, or cardiac dysfunction, recent lorazepam exposure, or need for neuromuscular blockers.

Endpoints

Primary

Lorazepam Pharmacokinetics (AUC)72 hours

Secondary

Analgosedative efficacy of Lorazepam72 hours
COMFORT-BEHAVIOURAL scale72 hours
Dropouts due to any adverse event72 hours
Adverse Events (AEs)/ Serious Adverse Events (SAEs)6 days
Vital signs (Blood Pressure)6 days
Vital signs (Heart Rate)6 days
Vital signs (Body Temperature)6 days
Plasma concentrations of Propylene Glycol72 hours

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