NCT03597477

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

Intranasal Dexmedetomidine Combined With Oral Midazolam for Procedure Sedation in Children With Autism Spectrum Disorders During Magnetic Resonance Imaging

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 136 (actual)
• Sponsor: Guangzhou Women and Children's Medical Center · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	participants were randomly allocated to receive sedation with oral midazolam(0.3 mg/kg) combined with 4 doses of intranasal dexmedetomidine(1.0, 1.5, 2.0, 2.5)

Timeline

• Start date: 2018-07-16
• Primary completion: 2020-09-17
• Completion: 2020-09-18
• First posted: 2018-07-24
• Last updated: 2021-02-25

Locations

1 site across 1 country: China