Protocolized Sedative Weaning Versus Usual Care in Pediatric Critically Ill, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- incidence of withdrawal symptom
研究概览
简要总结
Sedative and analgesic agents are widely used in the ICU. These agents can provide hypnotic effect, pain alleviation, cooperation, and synchronizing ventilatory support. Prolonged use of the agents can lead to withdrawal symptoms when the drugs are weaned.
Prior study showed the longer duration of sedative drugs, cumulative dose of medications and younger age were the risk factors of withdrawal syndrome. Additional, some study showed the sedation protocol can reduce the incidence of withdrawal syndrome. However, no worldwide standardized sedative weaning protocol including our hospital. The objectives in this study are to establish the sedative weaning protocol and to compare the protocol sedative weaning with the usual care weaning.
详细描述
Sedative and analgesic agents, particularly benzodiazepines and opioids, are widely used in PICU. These agents can provide calmness, hypnotic effect, pain alleviation, cooperation, immobilization and synchronizing ventilatory support.
Prolonged use of the agents can lead to withdrawal symptoms when the drugs are weaned.
Incidence of withdrawal syndrome is about 50%. Withdrawal syndrome can lead to unnecessary and costly diagnostic tests, prolongation of mechanical ventilation and hospital stay, and increasing of suffering. Prior study showed the longer duration of sedative drugs, cumulative dose of medications and younger age were the risk factors of withdrawal syndrome. Additional, some study showed the sedation protocol can reduce the incidence of withdrawal syndrome. However, no worldwide standardized sedative weaning protocol including our hospital.
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
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 1 mo to 18 yrs, at least 37 week of postmenstrual age
- •Patient who was admitted in PICU or intermediate ward at Ramathibodi hospital
- •use analgesic/sedative drugs (parenteral)≥ 3 days
排除标准
- •Patients in whom level of sedation or withdrawal assessment cannot be scored.
- •Patients transferred from other hospitals in which the patients have already presented of withdrawal symptoms
- •patient/parent refuse this study
研究组 & 干预措施
Sedative weaning protocol
We create the new sedative weaning protocol and then use the sedative weaning protocol.
干预措施: The sedative weaning protocol group (Other)
Usual Care
no use sedative weaning protocol. Sedative or/and analgesic medications are adjusted base on physician
干预措施: The usual group (Other)
结局指标
主要结局
incidence of withdrawal symptom
时间窗: 72 hour
次要结局
- sedation related adverse events(7 days)
- length of PICU stay(30 days)
研究者
Nattachai Anantasit
Assistant Professor
Ramathibodi Hospital