Observing adverse effects in children sedated for MRI
Frequency of Adverse Events and Factors Causing Adverse Events in Pediatric Patients Receiving Sedation for Magnetic Resonance Imaging: Observational Study
This study looks at how often kids under 16 experience side effects from sedation during MRI scans to help make the process safer for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 0 Days to 16 Years |
| Sex | All |
| Sponsor | Sisli Hamidiye Etfal Training and Research Hospital Academic / other |
| Locations | 1 site (Istanbul, Sarıyer) |
| Trial ID | NCT06467045 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the frequency of adverse effects in pediatric patients receiving sedation for magnetic resonance imaging (MRI). Conducted between June and September 2024, it will involve approximately 500 non-intubated patients under the age of 16. The study will collect data on patient demographics, comorbidities, medications, anesthetic drugs used, and any adverse effects experienced during the sedation process. The findings will help identify factors influencing the safety of sedation in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are non-intubated pediatric patients under the age of 16 who require sedation for MRI.
Not a fit: Patients who are intubated or older than 16 years will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety protocols for sedation in pediatric patients undergoing MRI, potentially reducing adverse effects.
How similar studies have performed: While the approach of observing adverse effects in pediatric sedation is common, this specific study focuses on MRI sedation, which may provide novel insights into this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All non-intubated patients under the age of 16 were included in the study. Exclusion Criteria: * Intubated pediatric patients or older than 16 years patients were excluded.
Where this trial is running
Istanbul, Sarıyer
- Sisli Hamidiye Etfal Research and Training Hospital — Istanbul, Sarıyer, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Kubra OZTURK
- Email: kubrizt@hotmail.com
- Phone: 0905385078036
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.