Quetiapine Treatment for Pediatric Delirium

• Status: Withdrawn
• Trial end date: 2020-03-02
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, double-blind, randomized controlled trial to begin determining the efficacy of quetiapine as a treatment for pediatric delirium in patients admitted to the pediatric intensive care unit (PICU)

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Treatments: Quetiapine Fumarate

Criteria

Inclusion Criteria:

• Age 0 - 21 years old

• PICU admission

• Positive CAPD scoring

• For developmentally normal children a CAPD score of ≥ 9

• For developmentally delayed a CAPD score of ≥ 9 and a Richmond Agitation Sedation Scale (RASS) fluctuation of at least 2 points in the last 24 hours

Exclusion Criteria:

• Patients under neuromuscular blockade and/or therapeutic hypothermia.

• Patients undergoing treatment of alcohol withdrawal.

• Patients unable to tolerate enteral medications

• Patients on antipsychotics

• Patients with a history of:

• hepatic encephalopathy, hepatitis

• elevated liver enzymes defined ALT or AST above normal range for age since hospitalization

• baseline QTc prolongation (defined as greater than 97th percentile for age or greater than 20% increase from baseline or previous QTc)

• major depressive disorder or bipolar disorder, and movement disorder.

• Patients who are pregnant

• Non-English and non-Spanish speaking subjects and/or parent/guardian