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Clinical trial

Stellate Ganglion Block in Children With Autistic Disorder: A Randomized Controlled Trial

ID
Name
SGB GUDU
Description
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.
Trial arms
Trial start
2024-03-01
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Not yet recruiting
Treatment
Routine therapy
During the treatment, All the participants are provided with the routine therapy, which included routine rehabilitation, cognitive training.
Arms:
Routine therapy+Stellate ganglion block, Routine therapy+placebo
Stellate ganglion block
The percutaneous approach via the paratracheal route was used for Stellate ganglion block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.
Arms:
Routine therapy+Stellate ganglion block
Lidocaine hydrochloride
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). Once a day, totally 10 days.
Arms:
Routine therapy+Stellate ganglion block
placebo injection
The percutaneous approach via the paratracheal route was used for Stellate ganglion block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.
Arms:
Routine therapy+placebo
Size
80
Primary endpoint
Childhood Autism Rating Scale
day 1 and day 10
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-03-20

1 organization

1 product

1 indication

Organization
Copka Sonpashan
Product
Lidocaine
Indication
Autism