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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06203522
Study type Observational
Source Centre Hospitalier Régional Metz-Thionville
Contact Arpiné EL NAR, PhD
Phone 0033387557766
Email arpine.el-nar@chr-metz-thionville.fr
Status Recruiting
Phase
Start date January 1, 2024
Completion date March 1, 2024

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