Sedation for Brainstem Evoked Auditory Response (BEAR) Testing Using Intravenous Pentobarbital
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|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|
|Actual Primary Completion Date :||July 2012|
|Actual 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 ]
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
|United States, Ohio|
|Akron Children's Hospital|
|Akron, Ohio, United States, 44308|
|Principal Investigator:||Urmila Tirodker, MD||Akron Children's Hospital|