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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06203522
Other study ID # 2023-12'Obs-CHRMT
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date March 1, 2024

Study information

Verified date January 2024
Source Centre Hospitalier Régional Metz-Thionville
Contact Arpiné EL NAR, PhD
Phone 0033387557766
Email arpine.el-nar@chr-metz-thionville.fr
Is FDA regulated No
Health authority
Study type Observational

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers
Gender All
Age group 3 Months to 18 Years
Eligibility Inclusion Criteria: - patients under 18 years of age sedated with DEX IN prior to MRI. Exclusion Criteria: - incomplete or missing medical records

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Data collection of successful completion of MRI
age, sex, autistic disorders, epilepsy, polyhandicap, non-autistic neurodevelopmental disorders, success of MRI procedure

Locations

Country Name City State
France CHR Metz-Thionville/Hopital Mercy Metz

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Successful Completion of MRI, defined as the radiologist having no reservations about the interpretation of the images. Successful Completion of MRI, defined as the radiologist having no reservations about the interpretation of the images (yes/no) Immediately after procedure
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