Stellate Ganglion Block in Children With Autistic Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Childhood Autism Rating Scale
研究概览
简要总结
The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:
Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.
详细描述
Autistic Disorder in children is becoming increasingly more. The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:
Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Months 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as Autistic Disorder.
- •Aged between 4 years old and 8 years old.
- •No contraindications to stellate ganglion block.
排除标准
- •Other significant physical or neurodevelopmental disorders.
- •Other significant medical conditions
研究组 & 干预措施
Routine therapy+Stellate ganglion block
The study lasts 10d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy.
Based on the invention above, the patients in the experimental group were provided with stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)
干预措施: Routine therapy (Behavioral)
Routine therapy+placebo
The study lasts 10d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy.
干预措施: Routine therapy (Behavioral)
Routine therapy+Stellate ganglion block
The study lasts 10d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy.
Based on the invention above, the patients in the experimental group were provided with stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)
干预措施: Stellate ganglion block (Procedure)
Routine therapy+Stellate ganglion block
The study lasts 10d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy.
Based on the invention above, the patients in the experimental group were provided with stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)
干预措施: Lidocaine hydrochloride (Drug)
Routine therapy+placebo
The study lasts 10d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy.
干预措施: placebo injection (Behavioral)
结局指标
主要结局
Childhood Autism Rating Scale
时间窗: day 1 and day 10
In the Childhood Autism Rating Scale, the rater observes the behavior of the child in specific situations and assigns scores based on a series of descriptive items. Each item is scored on a range of 0 to 4, with 0 indicating no abnormality and 4 indicating severe abnormality. The rater also considers the overall impression and severity of the child, resulting in a total score. The total score falls between 15 and 60, with higher scores indicating a higher level of autism severity.
次要结局
- Children's Communication Checklist(day 1 and day 10)
- Social Interaction Assessment Scale(day 1 and day 10)
- Children's Depression Inventory(day 1 and day 10)
- Childhood Anxiety Sensitivity Index(day 1 and day 10)
研究者
Copka Sonpashan
Research Director
Chao Phya Abhaibhubejhr Hospital