Frequency of Adverse Events in Pediatric Patients Receiving Sedation for Magnetic Resonance Imaging
NCT ID: NCT06467045
Last Updated: 2024-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2024-06-24
2024-10-05
Brief Summary
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Methods: Between 19.06.2024 and 16.09.2024, estimated 500 pediatric patients who underwent MRI under sedation will be prospectively observed. All non-intubated patients under the age of 16 will be included in the study. The demographic data, comorbidities, and medications of the patients, the procedures performed, the anesthetic drugs used, the expertise duration of the anesthesiologist, and the adverse effects encountered will be recorded.
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Detailed Description
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MRI imaging is a noisy, long-lasting technique that must be performed motionless . Pediatric patients requiring MRI imaging often have congenital anomalies, accompanying diseases, and acquired diseases due to birth trauma. Additionally, the complication rate related to the procedure may increase with a cooperative, mobile child. For this reason, day procedures in pediatric patients should be performed under sedation .
Some of the undesirable side effects encountered after sedation in pediatric patients include nausea, vomiting, cough, laryngospasm, bronchospasm, pulmonary aspiration, allergic reactions, anaphylaxis, extravasation, neurological damage, cardiovascular instability, and cardiac arrest . Although serious side effects are rarely encountered, minor undesirable side effects are frequently encountered . Many studies emphasize that serious undesirable side effects following sedation and general anesthesia in children are respiratory complications .
In our country, pediatric anesthesia applications outside the operating room are performed in a limited number of centers. Although there are retrospective studies on pediatric patients undergoing magnetic resonance imaging under sedation in the literature, it has been observed that there is insufficient data on large-scale observational studies.
The hypothesis of the study is that the frequency of anesthesia-related adverse effects is high in pediatric patients sedated in non-operating room environments. The primary aim of our study is to determine the frequency of adverse events in pediatric patients sedated for magnetic resonance imaging. Secondly, the investigators aimed to identify the factors causing these adverse events.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pediatric patients who received sedation for magnetic resonance imaging
All pediatric patients who received sedation for magnetic resonance imaging(MRI) in radiology unit will be added to this study. In the study, there is only one group. No comparisons are being made.
Pediatric patients who received sedation for magnetic resonance imaging
Pediatric patients who underwent MRI under sedation will be prospectively observed. All non-intubated patients under the age of 16 will be included in the study. The demographic data, comorbidities, and medications of the patients, the procedures performed, the anesthetic drugs used, the expertise duration of the anesthesiologist, and the adverse effects encountered will be recorded.
Interventions
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Pediatric patients who received sedation for magnetic resonance imaging
Pediatric patients who underwent MRI under sedation will be prospectively observed. All non-intubated patients under the age of 16 will be included in the study. The demographic data, comorbidities, and medications of the patients, the procedures performed, the anesthetic drugs used, the expertise duration of the anesthesiologist, and the adverse effects encountered will be recorded.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
0 Days
16 Years
ALL
No
Sponsors
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Sisli Hamidiye Etfal Training and Research Hospital
OTHER
Responsible Party
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Kubra OZTURK
principal investigator, medical doctor, anesthesiology and reanimation
Locations
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Sisli Hamidiye Etfal Research and Training Hospital
Istanbul, Sarıyer, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Cosgrove P, Krauss BS, Cravero JP, Fleegler EW. Predictors of Laryngospasm During 276,832 Episodes of Pediatric Procedural Sedation. Ann Emerg Med. 2022 Dec;80(6):485-496. doi: 10.1016/j.annemergmed.2022.05.002. Epub 2022 Jun 23.
Habre W, Disma N, Virag K, Becke K, Hansen TG, Johr M, Leva B, Morton NS, Vermeulen PM, Zielinska M, Boda K, Veyckemans F; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Incidence of severe critical events in paediatric anaesthesia (APRICOT): a prospective multicentre observational study in 261 hospitals in Europe. Lancet Respir Med. 2017 May;5(5):412-425. doi: 10.1016/S2213-2600(17)30116-9. Epub 2017 Mar 28.
Other Identifiers
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Sislietfal-kozturk-001
Identifier Type: -
Identifier Source: org_study_id
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