Childrens 0 to 18 Years of Age Who Require Moderate Sedation
Conditions
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.
Interventions
None listed
Sponsors
Akron Children's Hospital
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the efficacy of intravenous pentobarbital during BEAR testing in the pediatric population using a standardized protocol. | 2002 through 2010 |
| Evaluate the incidence of adverse events (major and minor) | 2002 through 2010 |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the incidence of paradoxical reaction | 2002 through 2010 |
| Evaluate the incidence of failed sedation | 2002 through 2010 |
| Identify predictors for failure and adverse events, if any | 2002 through 2010 |
Countries
United States
Outcome results
None listed