Sedation for Brainstem Evoked Auditory Response (BEAR) Testing Using Intravenous Pentobarbital
NCT01282112 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 416
Last updated 2014-06-26
Summary
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.
Conditions
- Childrens 0 to 18 Years of Age Who Require Moderate Sedation
Sponsors & Collaborators
-
Akron Children's Hospital
lead OTHER
Principal Investigators
-
Urmila Tirodker, MD · Akron Children's Hospital
Eligibility
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2012-07-31
- Completion
- 2012-07-31
Countries
- United States
Study Locations
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