Delirium | Efficacy of Quetiapine for Pediatric Delirium
Delirium research study
What is the primary objective of this study?
This study is designed to assess the safety and efficacy of quetiapine as treatment for pediatric delirium.
Who is eligible to participate?
Inclusion Criteria: - Any patient in the PICU aged 1 year to 21 years old who is diagnosed with delirium Exclusion Criteria: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:quetiapinePatients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.
Other:PlaceboPatients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
QuetiapineA randomized group will receive quetiapine as treatment for delirium.
PlaceboA randomized group will receive placebo, and not quetiapine.
Start Date: March 2015
Completed Date: December 2016
Phase: Phase 1/Phase 2
Primary Outcome: Time to First Resolution of Delirium
Secondary Outcome: Total ICU Days With Delirium
Study sponsors, principal investigator, and references
Principal Investigator: Chani Traube, MD
Lead Sponsor: Weill Medical College of Cornell University