Efficacy of Quetiapine for Pediatric Delirium
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of Quetiapine for Pediatric Delirium|
- Time to first resolution of delirium [ Time Frame: Within the first 10 days after study enrollment ] [ Designated as safety issue: No ]
- Total ICU days with delirium [ Time Frame: Within 30 days after study enrollment ] [ Designated as safety issue: No ]
- Change in delirium severity [ Time Frame: within 10 days of study enrollment ] [ Designated as safety issue: No ]
|Study Start Date:||March 2015|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
A randomized group will receive quetiapine as treatment for delirium.
Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.
Other Name: Seroquil
Placebo Comparator: Placebo
A randomized group will receive placebo, and not quetiapine.
Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.
Many children in the ICU become confused, due to their underlying illness or treatment effects. The medical term for this confusion is delirium. In adults, a medication called quetiapine has been effective in treating delirium. This is considered an "off label" use as the FDA has not approved quetiapine for this indication.
Pediatricians have been using quetiapine to treat delirium in children as well, but there is currently no data proving that it is effective in children. This study is being done to determine if quetiapine is effective for the treatment of ICU delirium in children.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02056171
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|NY Prebyterian Hospital/Weill Cornell Medical Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Chani Traube, MD||Weill Medical College of Cornell University|