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

Akron Children's Hospital

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT01282112

101014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 416 patients

Sex: All

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

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