Stellate Ganglion Block in Children With Autistic Disorder

Copka Sonpashan

Status: Not yet enrolling

Conditions: Autistic Disorder

Treatments: Drug: Lidocaine hydrochloride; Behavioral: placebo injection; Procedure: Stellate ganglion block; Behavioral: Routine therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06319599

SGB GUDU

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 4 months to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed as Autistic Disorder.
• Aged between 4 years old and 8 years old.
• No contraindications to stellate ganglion block.

Exclusion criteria

• Other significant physical or neurodevelopmental disorders.
• Other significant medical conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Routine therapy+Stellate ganglion block

Experimental group

Description:

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)

Treatment:

Drug: Lidocaine hydrochloride

Behavioral: Routine therapy

Procedure: Stellate ganglion block

Routine therapy+placebo

Placebo Comparator group

Description:

The study lasts 10d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy.

Treatment:

Behavioral: Routine therapy

Behavioral: placebo injection