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

C

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Conditions

MRI
EEG
Procedural Sedation

Treatments

Procedure: Data collection of successful completion of MRI

Study type

Observational

Funder types

Other

Identifiers

NCT06203522
2023-12'Obs-CHRMT

Details and patient eligibility

About

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.

Full 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.

Enrollment

81 patients

Sex

All

Ages

3 months to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients under 18 years of age sedated with DEX IN prior to MRI.

Exclusion criteria

  • incomplete or missing medical records

Trial design

81 participants in 1 patient group

MRI with Dexmedetomidin
Description:
Mean age is compared between the "pass" and "fail" groups using a Student's t-test accounting for inequality of variances. MRI success rates are compared between subgroups using Fischer's exact tests. Finally, factors related to MRI success rates are investigated using multivariate logistic regression, including all the factors described above.
Treatment:
Procedure: Data collection of successful completion of MRI

Trial contacts and locations

1

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Central trial contact

Arpiné EL NAR, PhD

Data sourced from clinicaltrials.gov

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