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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01282112
First Posted: January 24, 2011
Last Update Posted: June 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Akron Children's Hospital
  Purpose

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
Childrens 0 to 18 Years of Age Who Require Moderate Sedation

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Sedation for Brainstem Evoked Auditory Response (BEAR) Testing Using Intravenous Pentobarbital - A Retrospective Study

Resource links provided by NLM:


Further study details as provided by Akron Children's Hospital:

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

Secondary Outcome Measures:
  • Evaluate the incidence of paradoxical reaction [ Time Frame: 2002 through 2010 ]
  • Evaluate the incidence of failed sedation [ Time Frame: 2002 through 2010 ]
  • Identify predictors for failure and adverse events, if any [ Time Frame: 2002 through 2010 ]

Enrollment: 416
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282112


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