Pharmacologic Impact on Sedation Assessments

Completed

Conditions studied: Pediatric Acute Lung Injury

In brief

PISA is an ancillary study to the NIH funded clinical RESTORE Trial (U01 HL086622). This study will provide data that may allow for improved dosing recommendations in this critically ill population of children.

Key facts

Study ID

NCT01105663

Run by

Children's Hospital of Philadelphia

People needed

175

Starts

2010-03-01

Expected to finish

2013-12-01

Last updated by the study team

2017-01-27

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Intubated and mechanically ventilated for immediate post-operative care and stabilization
• 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 (e.g., post laryngotracheal construction) or anatomical obstruction of the lower airway (e.g., mediastinal mass)
• Ventilator dependent (including noninvasive) on Pediatric Intensive Care Unit (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
• Family/medical team has decided not to provide full support (patient treatment considered futile)
• Enrolled in any other sedation clinical trial concurrently or within the last 30 days
• Known allergy to any of the study medications.

Where it is running

• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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