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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 416

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Akron, Ohio, United States, 44308
      • Akron Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Akron Children's Hospital
• Investigators: Principal Investigator: Urmila Tirodker, MD, Akron Children's Hospital

Publications and helpful links

General Publications

• Mason KP, Zurakowski D, Karian VE, Connor L, Fontaine PJ, Burrows PE. Sedatives used in pediatric imaging: comparison of IV pentobarbital with IV pentobarbital with midazolam added. AJR Am J Roentgenol. 2001 Aug;177(2):427-30. doi: 10.2214/ajr.177.2.1770427.
• Mason KP, Zurakowski D, Connor L, Karian VE, Fontaine PJ, Sanborn PA, Burrows PE. Infant sedation for MR imaging and CT: oral versus intravenous pentobarbital. Radiology. 2004 Dec;233(3):723-8. doi: 10.1148/radiol.2333031872. Epub 2004 Oct 29.
• Karian VE, Burrows PE, Zurakowski D, Connor L, Mason KP. Sedation for pediatric radiological procedures: analysis of potential causes of sedation failure and paradoxical reactions. Pediatr Radiol. 1999 Nov;29(11):869-73. doi: 10.1007/s002470050715.
• Strain JD, Campbell JB, Harvey LA, Foley LC. IV Nembutal: safe sedation for children undergoing CT. AJR Am J Roentgenol. 1988 Nov;151(5):975-9. doi: 10.2214/ajr.151.5.975.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 21, 2011
• First Submitted That Met QC Criteria: January 21, 2011
• First Posted (Estimate): January 24, 2011

Study Record Updates

• Last Update Posted (Estimate): June 26, 2014
• Last Update Submitted That Met QC Criteria: June 25, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 101014