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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT01282112
First received: January 21, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • Evaluate the incidence of adverse events (major and minor) [ Time Frame: 2002 through 2010 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 700
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: March 2011 (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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Urmila Tirodker, M.D., Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT01282112     History of Changes
Other Study ID Numbers: 101014
Study First Received: January 21, 2011
Last Updated: January 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pentobarbital
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
 Central Nervous System Depressants
Physiological Effects of Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013