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

NCT ID: NCT03434366

Last Updated: 2022-04-12

Study Results

Results pending

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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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-20

Study Completion Date

2023-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ketamine and dexmedetomidine group

intranasal ketamine and dexmedetomidine was treated in the children

Group Type EXPERIMENTAL

ketamine and dexmedetomidine

Intervention Type DRUG

intranasal ketamine and dexmedetomidine for treatment for autism spectrum disorder

ketamine group

intranasal ketamine was treated in the children

Group Type EXPERIMENTAL

ketamine

Intervention Type DRUG

intranasal ketamine for treatment for autism spectrum disorder

control group

intranasal insaline was used in the children

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

intranasal saline for treatment for autism spectrum disorder

Interventions

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ketamine and dexmedetomidine

intranasal ketamine and dexmedetomidine for treatment for autism spectrum disorder

Intervention Type DRUG

ketamine

intranasal ketamine for treatment for autism spectrum disorder

Intervention Type DRUG

Saline

intranasal saline for treatment for autism spectrum disorder

Intervention Type DRUG

Other Intervention Names

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intranasal ketamine and dexmedetomidine intranasal ketamine intranasal saline

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ying Jun She, MD

Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qing Zhao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Women and Children's Medical Center

Locations

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Guangzhou Women and Children Medical Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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intranasal ketamine

Identifier Type: -

Identifier Source: org_study_id

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