Efficacy of Quetiapine for Pediatric Delirium

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

Detailed Description
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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.

Official Title
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Efficacy of Quetiapine for Pediatric Delirium

Conditions
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Delirium

Intervention / Treatment
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* Drug: quetiapine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quetiapine<br>A randomized group will receive quetiapine as treatment for delirium. | Drug: quetiapine<br>* Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.<br>* Other names: Seroquil;|
| Placebo Comparator: Placebo<br>A randomized group will receive placebo, and not quetiapine. | Other: Placebo<br>* Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Resolution of Delirium | 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. | Within the first 10 days after study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total ICU Days With Delirium | Participants were screened for delirium daily. This describes the number of days with delirium within the 10 day study period. | Within 10 days after study enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delirium, pediatrics, critical care, quetiapine