Quetiapine Treatment for Pediatric Delirium

Withdrawn before enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Delirium

In brief

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)

Key facts

Study ID

NCT03572257

Run by

Medical College of Wisconsin

People needed

0

Starts

2019-04-15

Expected to finish

2020-03-02

Last updated by the study team

2020-04-08

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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