NCT01282112已完成不适用
Sedation for Brainstem Evoked Auditory Response (BEAR) Testing Using Intravenous Pentobarbital - A Retrospective Study
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:
- to determine the efficacy of intravenous pentobarbital during BEAR testing in the pediatric population using a standardized protocol; and
- 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
- 是
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
研究点 (1)
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