NCT06203522

Factors Associated With Successful Completion of MRI in Children Undergoing a Vigil Sedation With Dexmedetomidin

Factors Associated With Successful Completion of MRI in Children Undergoing a Vigil Sedation With Dexmedetomidin: an Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: Centre Hospitalier Régional Metz-Thionville · Academic / Other
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: —

Summary

This is a retrospective cohort study aiming to determine whether the use of Dexmedetomidine (DEX) to sedate children prior to MRI scanning is more or less effective in children with autism spectrum disorders or other neurodevelopmental disorders compared to other children.

Detailed description

Performing brain MRI on children under 5, or in cases of autism or disability, is often complex. In fact, this examination requires total immobilization of the child for at least 20 minutes. The noise and the fact that the child is lying in a sort of tunnel add to the child's stress. General anesthesia with propofol is widely used in France, but requires invasive orotracheal intubation or mask ventilation. There are no national or international recommendations for pediatric MRI sedation procedures. Intranasal dexmedetomidine (DEX) is used for brain MRI, cardiac ultrasound, ophthalmology, dental treatment and brain computed tomography (CT) in patients aged 3 months to 12 years. Its superior efficacy has been demonstrated in a number of studies compared with the most commonly used medicated procedural sedation techniques, but only one study in France has prospectively analyzed the efficacy of DEX IN for performing cerebral MRIs, but without assessing efficacy and tolerance in subgroups of children: with or without neurodevelopmental disorders, epilepsy, autism, age.

Conditions

• Procedural Sedation
• EEG
• MRI

Interventions

Type	Name	Description
PROCEDURE	Data collection of successful completion of MRI	age, sex, autistic disorders, epilepsy, polyhandicap, non-autistic neurodevelopmental disorders, success of MRI procedure

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-03-30
• Completion: 2024-03-30
• First posted: 2024-01-12
• Last updated: 2024-08-09

Locations

1 site across 1 country: France