Opioid Withdrawal Symptoms in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Incidence of opioid withdrawal symptoms
研究概览
简要总结
Most critically ill patients encounter pain and distress from acute illness, medical procedures and devices as well as routine care in the intensive care units (ICU). Opioids are principal analgesics that alleviate moderate to severe pain and facilitate patients to co-operate the course of treatment. However, prolong administration of opioids especially in mechanically ventilated patients can cause withdrawal symptoms if analgesics are rapidly weaning or acutely disruption. The opioid withdrawal symptoms (OWS) are well reported in critically ill children that cause discomfort and prolong weaning from mechanical ventilation. Weaning opioids and treatment of withdrawal symptoms are needed in order to decrease ventilator days, ICU and hospital length of stay. Conversely, there is lack of knowledge about incidence, clinical presentation, time course and appropriated assessment tool for withdrawal detection. Therefore, we conduct the study to explore an incidence of OWS, to identify factors associated OWS, to establish the assessment tool for OWS, and to report efficacy of the pharmacological treatment for OWS, in adult critically ill patients.
详细描述
The primary objective of the study is to explore incidence of OWS in adult critically ill patients. The secondary objectives are 1) to identify factor associated OWS, 2) establish the assessment tool for OWS for adults and 3) to report efficacy of the pharmacological treatment in OWS in adults patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •On mechanical ventilator at least 24 hours
- •Received continuous infusion of opioid at least 24 hours
- •Patient or legal surrogate who is willing and able to provide written informed consent and comply with all protocol requirements
排除标准
- •Severely disturbed behavior pattern on account of underlying neurological disease (status epilepticus, encephalopathy, head trauma, brain injury, spinal cord injury)
- •Preexisting psychiatric diagnosis
- •Substance abuse prior to ICU admission
- •Chronic alcohol drinking
- •Pregnancy
- •End-of-life care
- •Death during ICU admission or during opioid IV infusion
研究组 & 干预措施
Mechanically ventilated critically ill patients
Mechanically ventilated critically ill patients who receive opioid as continuous infusion for more than 24 hours
干预措施: Opioids (Drug)
结局指标
主要结局
Incidence of opioid withdrawal symptoms
时间窗: 0, 1, 3, 6, 24 and 72 hour after reduction or discontinuation of intravenous opioid
Incidence of opioid withdrawal symptoms detected by self-developed assessment tool or the Diagnostic and Statistical Manual 5th edition (DSM-V)
次要结局
- Weaning days(28 days)
- ICU length of stay(28 days)
- Ventilator days(28 days)
研究者
Suthinee Taesotikul
Principal investigator
Mahidol University