Evaluating sedation effectiveness with dexmedetomidine in children undergoing brain MRI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy of moderate sedation using intra-nasal dexmedetomidine (DEX) in children undergoing brain MRI. It focuses on utilizing a sedation score derived from electroencephalogram (EEG) monitoring to determine whether a standard dose of DEX is sufficient or if a higher dose is necessary for successful sedation. The study targets children aged 12 months to 18 years, particularly those with conditions that may hinder cooperation during the procedure. By identifying the appropriate dosage of DEX, the study seeks to enhance the safety and effectiveness of procedural sedation in pediatric patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Indication of DEX sedation for brain NMRI at the CHR de Metz-Thionville

  * in a patient aged between 12 months and 5 years or
  * for a patient aged between 5 and 18 whose cooperation during the examination appears compromised (previous failure, autism spectrum disorders, etc.).
* Membership of a social security scheme
* Free and informed consent obtained from the patient's legal guardian(s).

Exclusion Criteria:

* Weight \< 10 kg
* Patients with contraindications to the use of DEX

  * Hypersensitivity to the active ingredient or to any of the excipients listed in the section on "Hypersensitivity".
  * Advanced heart block (level 2 or 3), unless pacemaker implanted
  * Uncontrolled hypotension
  * Acute cerebrovascular pathologies
* Patients with nasal obstruction
* Parental refusal of DEX administration
* Minors under guardianship
* Minors under judicial sanction

Where it's running

• CHR Metz-Thionville Hopital Femme-Mère Enfant
  Metz, France Recruiting

Study contacts

• Principal investigator: Anne-Charlotte CULLIER, MD — CHR Metz Thionville Hopital Femme Mère Enfant
• Study coordinator: Arpiné EL NAR, PhD
• Email: projet-recherche-clinique@chr-metz-thionville.fr
• Phone: 0033387557766

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.