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Sedation Management in Pediatric Patients With Acute Respiratory Failure (The RESTORE Study)

Principal Investigator

Gwenn Mclaughlin

Clinical Trial ID

Institutional Protocol # 20100564
National Clinical Trials Identifier NCT00814099

Clinical Trial Summary


Phase 3

Funding Agency/Sponsor



Intensive Care

Enrollment Eligibility

Inclusion Criteria:
- At least 2 weeks of age (and at least 42 weeks post-menstrual age) and less than 18
years of age
- Intubated and mechanically ventilated for acute lung 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 paralysis
- Primary pulmonary hypertension
- Critical airway or anatomical obstruction of the lower airway
- Ventilator dependent upon pediatric ICU admission
- Neuromuscular respiratory failure
- Spinal cord injury above the lumbar region
- Pain managed by patient-controlled analgesia or epidural catheter
- Patient transferred from an outside ICU where sedatives had already been administered
for more than 24 hours
- Family or medical team has decided not to provide full support
- Enrolled in any other critical care interventional clinical trial concurrently or in
the 30 days before study entry
- Known allergy to any of the study medications
- Pregnancy

Contact Information

Study Contact Gwenn Mclaughlin
Phone Number 3055856051
Get detailed information on ClinicalTrials.Gov