Procedure Sedation With Dexmedetomidine in Children With Autism Spectrum Disorders During Magnetic Resonance Imaging

Guangzhou Women and Children's Medical Center

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Drug: Dexmedetomidine

Study type: Observational

Funder types: Other

Identifiers

NCT03597477

Intranasal dexmedetomidine

Details and patient eligibility

About

Autism spectrum disorders (ASD) is a neurodevelopmental disorder and is characterized by functional impairment in social communication, restricted interests, and repetitive behaviors.The children with ASD has been shown different drug responses from the normal population of children. The children with ASD maybe more prone to elevate anxiety and the difficult of sedation during MRI scanning.The purpose of this investigation was to compare the effectiveness of dexmedetomidine sedation in children with and without ASD undergoing MRI scanning.

Full description

The use of medications in adolescents and young adults with ASD is extremely common. However, few data address the effectiveness and harms of medications for procedural sedation in this population. It's advisable to be used as a first line medication with alpha-2 agonists for procedure sedation. The primary goal of this study was to compare the effectiveness of dexmedetomidine sedation, also determine the 50% and 95% effective doses in children with and without ASD undergoing MRI scanning.

Enrollment: 136 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA physical status I or II,
• Patients aged 2 years through 12 years of age scheduled for procedure sedation during MRI scanning
• Patients must have a diagnosis of Autism Spectrum Disorder (ASD) according to the DSM V (autism group) or no history of neurodevelopmental concerns (control group). Child in control group is matched to an autism spectrum disorder participant according to age, gender, and ASA level.

Exclusion criteria

• Known allergy or hypersensitive reaction to dexmedetomidine
• Organ dysfunction, and significant developmental delays or behavior problems
• Cardiac arrhythmia
• Known. acyanotic congenital heart disease or children after cardiac interventional procedures for follow-up examination

Trial design

136 participants in 2 patient groups

Autism Spectrum Disorder

Description:

Patients with a diagnosis of autism spectrum disorder

Treatment:

Drug: Dexmedetomidine

Control

Description:

Patients with no developmental diagnoses

Treatment:

Drug: Dexmedetomidine