Clinical trial NCT01282112: Sedation for Brainstem Evoked Auditory Response (BEAR) Testing Using Intravenous Pentobarbital
Official title: Sedation for Brainstem Evoked Auditory Response (BEAR) Testing Using Intravenous Pentobarbital - A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childrens 0 to 18 Years of Age Who Require Moderate Sedation
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
First posted: 2011-01-24
Enrollment: 416
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children from 0 to 18 years of age undergoing BEAR testing using midazolam and pentobarbital protocol for moderate sedation.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine the efficacy of intravenous pentobarbital during BEAR testing in the pediatric population using a standardized protocol.
timeFrame: 2002 through 2010
measure: Evaluate the incidence of adverse events (major and minor)
timeFrame: 2002 through 2010
Secondary outcomes:
measure: Evaluate the incidence of paradoxical reaction
timeFrame: 2002 through 2010
measure: Evaluate the incidence of failed sedation
timeFrame: 2002 through 2010
measure: Identify predictors for failure and adverse events, if any
timeFrame: 2002 through 2010
Other outcomes:
Locations:
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
Study officials:
affiliation: Akron Children's Hospital
name: Urmila Tirodker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.2214/ajr.177.2.1770427.
citation: 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. doi: 10.1148/radiol.2333031872. Epub 2004 Oct 29.
citation: 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. doi: 10.1007/s002470050715.
citation: 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. doi: 10.2214/ajr.151.5.975.