跳至主要内容
临床试验/NCT01282112
NCT01282112已完成不适用

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

Akron Children's Hospital1 个研究点 分布在 1 个国家目标入组 416 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
416
试验地点
1
主要终点
Determine the efficacy of intravenous pentobarbital during BEAR testing in the pediatric population using a standardized protocol.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children from 0 to 18 years of age
  • undergoing BEAR testing using midazolam and pentobarbital protocol for moderate sedation

排除标准

  • Children greater that 18 years of age
  • Patients with incomplete data

结局指标

主要结局

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

时间窗: 2002 through 2010

Evaluate the incidence of adverse events (major and minor)

时间窗: 2002 through 2010

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验