Effectiveness of Lidocaine Injection on Stellate Ganglion in Pediatric Patients With Autism Spectrum Disorder: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Routine therapy
- Conditions
- Autistic Disorder
- Sponsor
- Muhammad
- Enrollment
- 80
- Primary Endpoint
- Childhood Autism Rating Scale
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Muhammad
Research Director
Ahmadu Bello University Teaching Hospital
Eligibility Criteria
Inclusion Criteria
- •Diagnosed as Autistic Disorder.
- •Aged between 3 years old and 6 years old.
- •No contraindications to stellate ganglion block.
Exclusion Criteria
- •Other significant physical or neurodevelopmental disorders.
- •Other significant medical conditions
Arms & Interventions
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.
Intervention: Routine therapy
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)
Intervention: Routine therapy
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)
Intervention: Injection
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)
Intervention: Lidocaine Hydrochloride
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.
Intervention: Injection
Outcomes
Primary Outcomes
Childhood Autism Rating Scale
Time Frame: 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.
Secondary Outcomes
- Childhood Anxiety Sensitivity Index(day 1 and day 10)
- 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)