Efficacy of Quetiapine for Pediatric Delirium

Weill Cornell Medicine (WCM)

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Delirium

Treatments

Drug: quetiapine

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02056171

1309014323

Details and patient eligibility

About

This study is designed to assess the safety and efficacy of quetiapine as treatment for pediatric delirium.

Full 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.

Enrollment

6 patients

Sex

All

Ages

1 to 22 years old

Volunteers

No Healthy Volunteers

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