Sedation for Brainstem Evoked Auditory Response (BEAR) Testing Using Intravenous Pentobarbital

Study Overview
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Brief Summary
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This is a retrospective chart review study (700 charts from 2002 to 2010)of children from 0 to 18 years of age who have undergone Brainstem Evoked Auditory Response (BEAR)testing using midazolam and pentobarbital protocol for moderate sedation. The specific aims of this study are two-fold: to determine the efficacy of intravenous pentobarbital during BEAR testing in the pediatric population using a standardized protocol; and to evaluate the incidence of adverse events (major and minor), paradoxical reaction and failed sedation and identify predictors for failure and adverse events if any.

Detailed Description
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Sedation Protocol: Versed: 0.1mg/kg IV Induction: 2mg/kg IV in children <1 year; 3mg/kg IV in children >1year Maintenance phase: 1mg/kg IV every 3 to 5 minutes with a maximal dose of 8mg/kg or 200 mg Definition of terms: Failed Sedation: A case in which a patient is inadequately sedated after receiving maximum required dosages such that the test cannot be completed. Paradoxical Reaction: Also known as 'pentobarbital rage' is defined as a patient experiencing sustained, inconsolable, and severe irritability or combativeness. This can occur anywhere between 30 minutes after administration of pentobarbital to post recovery phase. Prolonged Sedation: A case in which either the patient cannot be discharged 3 hours after administration of the last sedating medication. It could also be a case in which patient is not back to baseline in 24 hours. Hypoxia: This is defined as a sustained decrease in oxygen saturation (>30 seconds) of more than 10% from baseline. Time to goal sedation: Time in minutes from initial administration of midazolam to the achievement of adequate sedation of the patient/start of procedure. Time to recovery: time in minutes from the last dose of pentobarbital to recovery of baseline status. Time to discharge: Time in minutes from administration of midazolam to discharge of patient from recovery room.

Official Title
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Sedation for Brainstem Evoked Auditory Response (BEAR) Testing Using Intravenous Pentobarbital - A Retrospective Study

Conditions
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Childrens 0 to 18 Years of Age Who Require Moderate Sedation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children from 0 to 18 years of age undergoing BEAR testing using midazolam and pentobarbital protocol for moderate sedation Exclusion Criteria: Children greater that 18 years of age Patients with incomplete data

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the efficacy of intravenous pentobarbital during BEAR testing in the pediatric population using a standardized protocol. |  | 2002 through 2010 | 
| Evaluate the incidence of adverse events (major and minor) |  | 2002 through 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the incidence of paradoxical reaction |  | 2002 through 2010 | 
| Evaluate the incidence of failed sedation |  | 2002 through 2010 | 
| Identify predictors for failure and adverse events, if any |  | 2002 through 2010 |