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

Study Description

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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.

Condition or disease
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 Design

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Study Type :	Observational
Actual Enrollment :	416 participants
Time Perspective:	Retrospective
Official Title:	Sedation for Brainstem Evoked Auditory Response (BEAR) Testing Using Intravenous Pentobarbital - A Retrospective Study
Study Start Date :	January 2011
Actual Primary Completion Date :	July 2012
Actual Study Completion Date :	July 2012

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Determine the efficacy of intravenous pentobarbital during BEAR testing in the pediatric population using a standardized protocol. [ Time Frame: 2002 through 2010 ]
2. Evaluate the incidence of adverse events (major and minor) [ Time Frame: 2002 through 2010 ]

Secondary Outcome Measures :

1. Evaluate the incidence of paradoxical reaction [ Time Frame: 2002 through 2010 ]
2. Evaluate the incidence of failed sedation [ Time Frame: 2002 through 2010 ]
3. Identify predictors for failure and adverse events, if any [ Time Frame: 2002 through 2010 ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
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.

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Akron Children's Hospital

Investigators

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

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. 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.

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.

Responsible Party:	Akron Children's Hospital
ClinicalTrials.gov Identifier:	NCT01282112 History of Changes
Other Study ID Numbers:	101014
First Posted:	January 24, 2011
Last Update Posted:	June 26, 2014
Last Verified:	June 2014

Additional relevant MeSH terms:

Pentobarbital; Adjuvants, Anesthesia; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs	GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action