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

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.

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Key information

Conditions

Procedural Sedation EEG MRI

Age range

3 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Metz-Thionville/Hopital Mercy

Metz, 57085, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

incomplete or missing medical records

Treatment and study plan

Data collection of successful completion of MRI

Procedure

age, sex, autistic disorders, epilepsy, polyhandicap, non-autistic neurodevelopmental disorders, success of MRI procedure

Primary outcomes

Successful Completion of MRI, defined as the radiologist having no reservations about the interpretation of the images.

Time frame: Immediately after procedure

Successful Completion of MRI, defined as the radiologist having no reservations about the interpretation of the images (yes/no)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

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

Acronym: RIDEX

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jan 12, 2024
Registry last updated: Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed