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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT01282112
First received: January 21, 2011
Last updated: June 25, 2014
Last verified: June 2014

January 21, 2011
June 25, 2014
January 2011
July 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01282112 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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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.

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.
Observational
Time Perspective: Retrospective
Not Provided
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Non-Probability Sample

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

Childrens 0 to 18 Years of Age Who Require Moderate Sedation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
416
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
up to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01282112
101014
No
Akron Children's Hospital
Akron Children's Hospital
Not Provided
Principal Investigator: Urmila Tirodker, MD Akron Children's Hospital
Akron Children's Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP