Table 1 Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) eligibility criteria

Inclusion criteria:

 • ≥ 2 weeks of age, ≥ 42 weeks post-menstrual age, and < 18 years of age

 • Supported on mechanical ventilation for acute lung disease. Lung disease includes both airways and parenchymal disease

Exclusion criteria:

 • Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt

 • History of single ventricle at any stage of repair

 • Congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis

 • Primary pulmonary hypertension

 • Critical airway (e.g., post laryngotracheal reconstruction) or anatomical obstruction of the lower airway (e.g., mediastinal mass)

 • Ventilator dependent (including non-invasive) on PICU admission (chronic assisted ventilation)

 • Neuromuscular respiratory failure

 • Spinal cord injury above the lumbar region

 • Pain managed by patient-controlled analgesia (PCA) or epidural catheter

 • Patient transferred from an outside ICU where sedatives had already been administered for more than 24 h

 • Family/medical team have decided not to provide full support (patient treatment considered futile)

 • Enrolled in any other critical care interventional clinical trial concurrently or within the last 30 days

 • Known allergy to any of the study medications

 • Pregnancy