Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder

Guangzhou Women and Children's Medical Center

Status and phase: Suspended; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Drug: Saline; Drug: ketamine and dexmedetomidine; Drug: ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03434366

intranasal ketamine

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 2 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. meet autism diagnostic criteria based on DSM-5/ADI-R/ADOS
2. children aged 2 years through 15 years of age
3. parents/guardians can cooperate with the study and sign informed consent
4. ASA score I or II

Exclusion criteria

1. with epilepsy or other genetic diseases
2. changes in drugs or in any intervention during the study
3. Presence of cardiac disease including coronary artery disease, congestive heart failure, or uncontrolled hypertension per medical history
4. Airway instability, tracheal surgery, or tracheal stenosis per medical history.
5. History of drug or alcohol abuse
6. Central nervous system masses or hydrocephalus per medical history

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 3 patient groups, including a placebo group

ketamine and dexmedetomidine group

Experimental group

Description:

intranasal ketamine and dexmedetomidine was treated in the children

Treatment:

Drug: ketamine and dexmedetomidine

ketamine group

Experimental group

Description:

intranasal ketamine was treated in the children

Treatment:

Drug: ketamine

control group

Placebo Comparator group

Description:

intranasal insaline was used in the children

Treatment:

Drug: Saline