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临床试验/NCT05691088
NCT05691088招募中不适用

To Evaluate the Clinical Efficacy of Standardized Use of Acetaminophen in Mechanical Ventilation in Children With New Coronary Pneumonia

The Second Clinical Medical College of Jinan University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2022年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
128
试验地点
1
主要终点
Mechanical ventilation time

研究概览

简要总结

Patients were randomized to receive either paracetamol during mechanical ventilation. When patients were randomized to receive paracetamol (40 mg/kg per day in 4 doses), a placebo infusion of normal saline was administered continuously at the same rate as an equivalent infusion. Placebos could not be distinguished from the active study drug in color, odor, or viscosity.

In both study groups, IMV was maintained with sufentanil (0-0.2 mcg/kg/h), propofol (0-4 mg/kg/h), and dexmedetomidine (0-1 mcg/kg/h). Assessment of sedation levels by the bedside nurse using the FLACC pain scale to determine if the child is adequately comfortable or in need of more or less medication to maintain adequate ventilation. Assessment of sedation levels by the bedside nurse using the FLACC pain scale (every 6 hours as a minimum time interval).

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
0 Years 至 16 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Inclusion criteria were body weight greater than 1500 g; and mechanically ventilated patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

排除标准

  • •Exclusion criteria were admitted with a tracheostomy in situ; extracorporeal membrane oxygenation treatment; neurologic dysfunction, hepatic dysfunction, or renal insufficiency; known allergy to or intolerance for paracetamol; and administration of paracetamol in the 24 hours prior to mechanical ventilation.

研究组 & 干预措施

Group B

No Intervention

Equivalent physiological saline

Group A

Experimental

Paracetamol injection

干预措施: Paracetamol injection (Device)

结局指标

主要结局

Mechanical ventilation time

时间窗: an average of 5 days

次要结局

  • Length of ICU stay time(an average of 1 week)

研究者

发起方
The Second Clinical Medical College of Jinan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hu Anmin

The Second Clinical Medical College of Jinan University

The Second Clinical Medical College of Jinan University

研究点 (1)

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