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

Completed

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

• Registration Number: NCT01282112
• Lead Sponsor: Akron Children's Hospital

Brief Summary

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:

1. to determine the efficacy of intravenous pentobarbital during BEAR testing in the pediatric population using a standardized protocol; and

2. 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

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-01-21
• Study First Posted: 2011-01-24
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

• Children from 0 to 18 years of age
• undergoing BEAR testing using midazolam and pentobarbital protocol for moderate sedation

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Exclusion Criteria

• Children greater that 18 years of age
• Patients with incomplete data

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Akron Children's Hospital; 🇺🇸 Akron, Ohio, United States