Cycling of Sedative Infusions in Critically Ill Pediatric Patients
Stopped early · Not applicable · Has a placebo group
Conditions studied: Respiratory Failure
In brief
The purpose of this study is to determine if the reduction of the total amount of sedative critically pediatric ill patients receive in the PICU will achieve a significant decrease in mechanical ventilation days and a decrease in the overall length of stay in the PICU and hospital.
Key facts
- Study ID
- NCT01333059
- Run by
- Javier Gelvez, MD
- People needed
- 25
- Starts
- 2010-09-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2019-01-15
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Less than or equal to 18 years of age
- Intubated and mechanically ventilated
- Expected to require continuous infusions of sedatives for at least 48 hours
- Parent or legal guardian available for informed consent
- Males and females of any race are eligible
You may not qualify if…
- Less than 72 hours after surgery
- Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
- Critical airway (according to PICU Attending)
- Ventilator dependent (including noninvasive) on PICU admission
- Greater than 48 hours of continuous sedation infusion(s)
- Neuromuscular respiratory failure
- Managed by patient controlled analgesia (PCA) or epidural catheter
- Known allergy to any of the study medications (fentanyl or midazolam)
- Family/Medical team have decided not to provide full support (patient treatment considered futile)
- Patient requires ECMO
- Head trauma requiring intracranial pressure monitoring
- Pregnancy
- Following resuscitation from cardiorespiratory arrest whose initial pH is < 6.9
- ICU Attending judgment that patient should be excluded for safety reasons
Where it is running
- Cook Children's Medical Center — Fort Worth, Texas, United States
Full record on ClinicalTrials.gov
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