Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Autism Diagnostic Interview Revised (ADI-R)
研究概览
简要总结
Autism spectrum disorder (ASD) is a life-long neurodevelopmental disorder characterized by qualitative abnormalities in reciprocal social interactions and patterns of communication, and by a restricted, stereotyped, repetitive repertoire of interests and activities. The use of medications in adolescents and young adults with ASD is extremely common. However, few data address the effectiveness and harms of medications specifically in this population.
The purpose of the study is to determine the efficacy and safety of intranasal ketamine with dexmedetomidine in children with ASD.
详细描述
The use of medications in adolescents and young adults with ASD is extremely common. few data address the effectiveness and harms of medications specifically in this population. A previous study reported the first case study demonstrating clinical improvement in mood and eye fixation scores from intranasal ketamine treatment in a "complicated" subject with autism spectrum disorderHowever,The purpose of the study is to determine the efficacy and safety of intranasal ketamine with dexmedetomidine in children with ASD.
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
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •meet autism diagnostic criteria based on DSM-5/ADI-R/ADOS
- •children aged 2 years through 15 years of age
- •parents/guardians can cooperate with the study and sign informed consent
- •ASA score I or II
排除标准
- •with epilepsy or other genetic diseases
- •changes in drugs or in any intervention during the study
- •Presence of cardiac disease including coronary artery disease, congestive heart failure, or uncontrolled hypertension per medical history
- •Airway instability, tracheal surgery, or tracheal stenosis per medical history.
- •History of drug or alcohol abuse
- •Central nervous system masses or hydrocephalus per medical history
研究组 & 干预措施
ketamine and dexmedetomidine group
intranasal ketamine and dexmedetomidine was treated in the children
干预措施: ketamine and dexmedetomidine (Drug)
ketamine group
intranasal ketamine was treated in the children
干预措施: ketamine (Drug)
control group
intranasal insaline was used in the children
干预措施: Saline (Drug)
结局指标
主要结局
Autism Diagnostic Interview Revised (ADI-R)
时间窗: change from baseline at 2, 5 and 12 weeks
The Autism Diagnostic Interview Revised is an investigator-based semi-structured diagnostic interview, The ADI-R provides empirically derived diagnostic algorithms for three subdomains of qualitative impairments. The social interaction domain includes questions about emotional sharing, offering and seeking comfort, social smiling, and social responding comprising four subscores. The second domain (communication) assesses stereotyped expressions, pronoun reversal, and the social usage of language (B1-B4). In the third domain repetitive and stereotyped behavior as hand- and finger mannerisms, unusual sensory interest or activities are investigated by four subscales. Most items are scored from zero to three, relying on the interviewer to make judgements on child's behaviour based on the recall of information from parents/carers. . A total score is then calculated for each of the three subdomains. The ADI-R has an algorithm for autism based on scores in these three areas and on onset.
Autism Diagnostic Observation Schedule (ADOS)
时间窗: change from baseline at 2, 5 and 12 weeks
The Autism Diagnostic Observation Schedule (ADOS) is a semi-structured assessment of communication, social interaction and play or imaginative use of materials for individuals suspected of having autism or other ASD. It consists of four modules, each of which is appropriate for children, adolescents and adults of differing developmental and language levels, ranging from no expressive or receptive language to verbally fluent adults. The examiner selects the module that is most appropriate for a particular child, adolescent on the basis of his/her expressive language level and chronological age. Selected algorithm items relating to social interaction and communication are then entered into an algorithm. The scores must meet the separate cut-offs for both the communication and social domains and the cut-off for the summation of the two. Repetitive behaviours are recorded and coded as part of the clinical observations but do not contribute to the ADOS summary algorithm.
次要结局
- Childhood Autism Rating Scale (CARS)(change from baseline at 2, 5 and 12 weeks)
- autism behavior checklist (ABC)(change from baseline at 2, 5 and 12 weeks)
- magnetic resonance spectroscopy(MRS)(change from baseline at 5 and 12 weeks)
研究者
Ying Jun She, MD
Department of Anesthesiology
Guangzhou Women and Children's Medical Center