Effectiveness of Lidocaine Injection on Stellate Ganglion in Pediatric Patients With Autism Spectrum Disorder
NCT ID: NCT06301685
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2024-03-31
2024-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Routine therapy+Stellate ganglion block
The study lasts 10 days for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy.
Based on the invention above, the patients were provided with stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)
Routine therapy
The study lasts 10 days for each patient. During the treatment, All the participants are provided with the routine therapy, which included routine rehabilitation, cognitive training.
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.
Lidocaine Hydrochloride
the patients were provided with Stellate ganglion block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). 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. once a day.
Routine therapy+Placebo
The study lasts 20d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy and placebo injection.
Routine therapy
The study lasts 10 days for each patient. During the treatment, All the participants are provided with the routine therapy, which included routine rehabilitation, cognitive training.
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.
Interventions
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Routine therapy
The study lasts 10 days for each patient. During the treatment, All the participants are provided with the routine therapy, which included routine rehabilitation, cognitive training.
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.
Lidocaine Hydrochloride
the patients were provided with Stellate ganglion block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). 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. once a day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged between 3 years old and 6 years old.
* No contraindications to stellate ganglion block.
Exclusion Criteria
* Other significant medical conditions
3 Years
6 Years
ALL
No
Sponsors
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Muhammad
OTHER
Responsible Party
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Muhammad
Research Director
Principal Investigators
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Nieto Luis, Master
Role: STUDY_DIRECTOR
Site Coordinator of United Medical Group
Central Contacts
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Other Identifiers
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SGB-AST
Identifier Type: -
Identifier Source: org_study_id
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