Sedation for Brainstem Evoked Auditory Response (BEAR) Testing Using Intravenous Pentobarbital
|ClinicalTrials.gov Identifier: NCT01282112|
Recruitment Status : Completed
First Posted : January 24, 2011
Last Update Posted : June 26, 2014
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:
- to determine the efficacy of intravenous pentobarbital during BEAR testing in the pediatric population using a standardized protocol; and
- 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|
- 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|
|Actual Enrollment :||416 participants|
|Official Title:||Sedation for Brainstem Evoked Auditory Response (BEAR) Testing Using Intravenous Pentobarbital - A Retrospective Study|
|Study Start Date :||January 2011|
|Primary Completion Date :||July 2012|
|Study Completion Date :||July 2012|
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282112
|United States, Ohio|
|Akron Children's Hospital|
|Akron, Ohio, United States, 44308|
|Principal Investigator:||Urmila Tirodker, MD||Akron Children's Hospital|