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NCT Number: NCT01282112

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

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.

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Key information

Conditions

Childrens 0 to 18 Years of Age Who Require Moderate Sedation

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Akron Children's Hospital

Akron, Ohio, 44308, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Determine the efficacy of intravenous pentobarbital during BEAR testing in the pediatric population using a standardized protocol.

    Time frame: 2002 through 2010

  2. Evaluate the incidence of adverse events (major and minor)

    Time frame: 2002 through 2010

Secondary outcomes

  1. Evaluate the incidence of paradoxical reaction

    Time frame: 2002 through 2010

  2. Evaluate the incidence of failed sedation

    Time frame: 2002 through 2010

  3. Identify predictors for failure and adverse events, if any

    Time frame: 2002 through 2010

Sponsors and collaborators

Lead sponsor

Akron Children's Hospital

Other

Registry information

Official study title

Sedation for Brainstem Evoked Auditory Response (BEAR) Testing Using Intravenous Pentobarbital - A Retrospective Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 24, 2011
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.