Safety and Efficacy of Fentanyl Citrate in Combination With Midazolam in Critically Ill Children With Mechanical Ventilation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- difference between measured Comfort behavior scale and target Comfort behavior scale
研究概览
简要总结
Title: Safety and efficacy of fentanyl citrate in combination with midazolam in critically ill children with mechanical ventilation
Objective: To evaluate the safety and efficacy of fentanyl citrate in combination with midazolam in children with mechanical ventilation.
Design: Double-blind randomized controlled study
Patients: Patients age 2 months through 18 years who are admitted in Seoul National University Hospital pediatric intensive care unit, and applied with mechanical ventilation.
Interventions: After enrollment of patient, blind reagent (fentanyl citrate or normal saline) is prepared by assigned pharmacist. Investigators, caregivers, patient, and parents of the patient don't know whether the blind reagent is fentanyl citrate or not, but only preparing pharmacist knows that.
Protocol: All enrolled patients receive continuous infusion of midazolam and blind reagent. The start time of study is when the continuous infusion of midazolam and blind reagent are begun. Assigned research nurse check Comfort behavior scale of the patient every hour regularly, and whenever the patient seem to be overactive. Endpoint of the study is 48 hours after begining. If there is any adverse effect or unexpected event, however, the study can be early terminated.
详细描述
Comfort behavior scale consists of 7 components of alertness, calmness, respiratory response, crying, physical movement, muscle tone, and facial tension. Because intubated patients cannot be evaluated 'crying', however, we use 6 components among total of all 7 components, except 'crying'.
Adverse effect of fentanyl include hypotension, coma, and ileus. Unexpected event means the situation which study cannot last in, such as withdrawal of consent, necessity of drugs which can affect the level of consciousness of the patient, emergent interventional procedure, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children mechanically ventilated
- •age : from 2 months to 18 years
排除标准
- •children with neurologic disease
- •children with drugs which can affect the level of consciousness
- •children with renal disease
- •children with hypotension (systolic blood pressure < 70 + (2 x age in year) mmHg)
研究组 & 干预措施
Fentanyl
midazolam and fentanyl citrate infusion
干预措施: midazolam and fentanyl citrate infusion (Drug)
Control
midazolam and normal saline infusion
干预措施: midazolam and normal saline infusion (Drug)
结局指标
主要结局
difference between measured Comfort behavior scale and target Comfort behavior scale
时间窗: from the start of fentanyl/placebo infusion to 48 hours after start of infusion
次要结局
- adverse effect(from the start of fentanyl/placebo infusion to 48 hour after start of infusion)
- renal dysfunction(from the start of fentanyl/placebo infusion to 48 hour after start of infusion)
- sedation failure(from the start of fentanyl/placebo infusion to 48 hour after start of infusion)
- mortality(from the start of fentanyl/placebo infusion to 48 hour after start of infusion)
研究者
June Dong Park, MD
Professor
Seoul National University Hospital