A Randomized Controlled Trial Comparing Lorazepam With Midazolam for Sedation of Mechanically Ventilated Pediatric Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Drug dose required to maintain a target comfort score of 17 ≤ 26
研究概览
简要总结
This clinical trial is being performed under the Best Pharmaceuticals for Children Act, signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The purpose of this study is to make sure that lorazepam, when given to children who are very sick in the Intensive Care Unit and who are on a breathing machine, is safe and works as well as a drug called midazolam. Midazolam is already approved by the FDA for this use, but lorazepam is not, even though both drugs are commonly used for sedation.
详细描述
Lorazepam is used clinically for sedation of mechanically ventilated children, but has not been approved by the FDA for this indication in children. The purpose of this study, in response to the Written Request by FDA, is to determine the safety, efficacy, and dosage required for lorazepam compared with midazolam, which is approved by FDA for children for this indication.
Study participants must be children who are critically ill and receiving mechanical ventilation who require sedation. Participants will be randomized to lorazepam (intermittent bolus or continuous infusion) or midazolam (continuous infusion). Sedation will be monitored using the COMFORT score. Blood will be drawn to measure lorazepam/midazolam plasma concentrations, and to measure the plasma concentrations of excipients (benzyl alcohol and glycols) in patients receiving lorazepam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females from full term birth (at least 38 weeks post conceptual age) through 18 years
- •Patients must be intubated and mechanically ventilated in the PICU less than or equal to 24 hr
- •Patients in whom the use of neuromuscular blocking agents would normally NOT be expected to be used.
- •Patient's parent or guardian has signed a consent form prior to initiation of study procedures
- •Patients with cardiac, renal, or hepatic dysfunction will be actively sought
排除标准
- •Life expectancy < 48 hr
- •Expected duration of sedation < 48 hr
- •Patient with history of hypersensitivity to any component of lorazepam, midazolam, fentanyl, thiopental
- •Females pregnant or breast feeding
- •Patient requires sedatives or analgesics other than study drug
研究组 & 干预措施
Lorazepam Intermittent bolus
lorazepam administered by intermittent bolus
干预措施: Lorazepam (Drug)
lorazepam continuous infusion
lorazepam administered by continuous infusion
干预措施: Lorazepam CI (Drug)
midazolam continous infusion
midazolam administered by continous infusion
干预措施: Midazolam (Drug)
结局指标
主要结局
Drug dose required to maintain a target comfort score of 17 ≤ 26
时间窗: Minimum of 8 hours
Measurement of efficacy
Number of bolus doses required to achieve a comfort score of 17 ≤ 26
时间窗: minimum of 8 hours
A measurement of drug efficacy
Rate of Severe Adverse Events
时间窗: Minimum 8 hours
Duration of study participation
次要结局
未报告次要终点