Intranasal Ketamine With Dexmedetomidine for the Treatment of Children With Autism Spectrum Disorder
NCT ID: NCT03434366
Last Updated: 2022-04-12
Study Results
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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SUSPENDED
PHASE2
50 participants
INTERVENTIONAL
2018-01-20
2023-12-30
Brief Summary
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The purpose of the study is to determine the efficacy and safety of intranasal ketamine with dexmedetomidine in children with ASD.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ketamine and dexmedetomidine group
intranasal ketamine and dexmedetomidine was treated in the children
ketamine and dexmedetomidine
intranasal ketamine and dexmedetomidine for treatment for autism spectrum disorder
ketamine group
intranasal ketamine was treated in the children
ketamine
intranasal ketamine for treatment for autism spectrum disorder
control group
intranasal insaline was used in the children
Saline
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
ketamine
intranasal ketamine for treatment for autism spectrum disorder
Saline
intranasal saline for treatment for autism spectrum disorder
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
2 Years
15 Years
ALL
Yes
Sponsors
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Guangzhou Women and Children's Medical Center
OTHER
Responsible Party
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Ying Jun She, MD
Department of Anesthesiology
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
Countries
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Other Identifiers
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intranasal ketamine
Identifier Type: -
Identifier Source: org_study_id
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