NCT06467045

Frequency of Adverse Events in Pediatric Patients Receiving Sedation for Magnetic Resonance Imaging

Frequency of Adverse Events and Factors Causing Adverse Events in Pediatric Patients Receiving Sedation for Magnetic Resonance Imaging: Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital · Academic / Other
• Sex: All
• Age: 0 Days – 16 Years
• Healthy volunteers: —

Summary

Introduction:The application of anesthesia outside the operating room for pediatric patients has increased in recent years. For diagnostic and treatment follow-up purposes, magnetic resonance imaging (MRI) requires the pediatric patient to remain still, necessitating sedation. The study aimed to determine the frequency of adverse effects and influencing factors in pediatric patients undergoing sedation during MRI. 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.

Detailed description

In modern times, the application of anesthesia outside the operating room is increasingly common in pediatric patients for day procedures and imaging by clinics such as gastroenterology, cardiology, oncology, and radiology . In addition to the difficulty of airway control in pediatric patients, the risks increase in non-operating room settings due to the unfamiliarity of the environment and being far from the operating room. Moreover, anesthesia application is risky due to patient-independent reasons such as the insufficient number of auxiliary staff, the inadequate emergency experience of the personnel in the units, and the limited number and variety of materials . Therefore, anesthesia application in pediatric patients is specialized and requires an experienced anesthesia team . 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

• Sedation
• Pediatric Anesthesia
• Magnetic Resonance Imaging
• Adverse Effect

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2024-06-24
• Primary completion: 2024-09-21
• Completion: 2024-10-05
• First posted: 2024-06-20
• Last updated: 2024-06-25

Locations

1 site across 1 country: Turkey (Türkiye)