Efficacy of Quetiapine for Pediatric Delirium
- Registration Number
- NCT02056171
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
This study is designed to assess the safety and efficacy of quetiapine as treatment for pediatric delirium.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- Any patient in the PICU aged 1 year to 21 years old who is diagnosed with delirium
- Age <1
- Richmond Agitation Sedation Scale (RASS) score of -4 or -5 (deeply sedated or unarousable).
- current treatment for alcohol withdrawal
- hepatic encephalopathy
- pregnancy
- diagnosis of major depressive disorder or bipolar disorder
- diagnosis of movement disorder
- diagnosis of diabetic ketoacidosis
- baseline QTc >500 milliseconds
- non-English speaking subjects and/or parent/guardian
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Quetiapine quetiapine A randomized group will receive quetiapine as treatment for delirium. Placebo Placebo A randomized group will receive placebo, and not quetiapine.
- Primary Outcome Measures
Name Time Method Time to First Resolution of Delirium Within the first 10 days after study enrollment Participants were screened for delirium daily. This describes the number of days from study drug initiation (either quetiapine or placebo) to first resolution of delirium (defined as a score of less than 9 on teh Cornell Assessment of Pediatric Delirium \[CAPD\]). If delirium did not resolve within the 10 day period, this defaults to 10 days.
- Secondary Outcome Measures
Name Time Method Total ICU Days With Delirium Within 10 days after study enrollment Participants were screened for delirium daily. This describes the number of days with delirium within the 10 day study period.
Trial Locations
- Locations (2)
Columbia University Medical Center
🇺🇸New York, New York, United States
NY Prebyterian Hospital/Weill Cornell Medical Center
🇺🇸New York, New York, United States