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

Overview

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.

Full Title of Study: “Sedation for Brainstem Evoked Auditory Response (BEAR) Testing Using Intravenous Pentobarbital – A Retrospective Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: July 2012

Detailed Description

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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Akron Children’s Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Urmila Tirodker, MD, Principal Investigator, Akron Children’s Hospital

References

Mason KP, Zurakowski D, Karian VE, Connor L, Fontaine PJ, Burrows PE. Sedatives used in pediatric imaging: comparison of IV pentobarbital with IV pentobarbital with midazolam added. AJR Am J Roentgenol. 2001 Aug;177(2):427-30.

Mason KP, Zurakowski D, Connor L, Karian VE, Fontaine PJ, Sanborn PA, Burrows PE. Infant sedation for MR imaging and CT: oral versus intravenous pentobarbital. Radiology. 2004 Dec;233(3):723-8. Epub 2004 Oct 29.

Karian VE, Burrows PE, Zurakowski D, Connor L, Mason KP. Sedation for pediatric radiological procedures: analysis of potential causes of sedation failure and paradoxical reactions. Pediatr Radiol. 1999 Nov;29(11):869-73.

Strain JD, Campbell JB, Harvey LA, Foley LC. IV Nembutal: safe sedation for children undergoing CT. AJR Am J Roentgenol. 1988 Nov;151(5):975-9.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.