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

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Guangzhou Women and Children's Medical Center
• Treatments: Dexmedetomidine; Ketamine

Criteria

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