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

Magnetic Resonance Imaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06467045
• Other study ID #: Sislietfal-kozturk-001
• Status: Not yet recruiting
• Start date: June 24, 2024
• Est. completion date: October 5, 2024

Study information

• Verified date: June 2024
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: Kubra OZTURK
• Phone: 0905385078036
• Email: kubrizt[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: October 5, 2024
• Est. primary completion date: September 21, 2024
• Gender: All
• Age group: 0 Days to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

References & Publications (2)

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. — View Citation

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 a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative adverse events	In the study, the investigators will record the adverse effects includes respiratory, circulatory, neurological systems observed during the procedure. Respiratory adverse effects includes bronchospasm, laryngospasm, apnea, pulmonary aspiration, anaphylaxis. Circulatory system adverse affects includes hypotension, hypertension, cardiac arrest. In the study, neurological side effects such as glasgow coma scale impairment and convulsions will be recorded.	1 hours
Primary	Postoperative adverse events	In the study, the investigators will record the adverse effects includes respiratory, circulatory, neurological systems the 2 hours following the procedure. Respiratory adverse effects includes bronchospasm, laryngospasm, apnea, pulmonary aspiration, anaphylaxis. Circulatory system adverse affects includes hypotension, hypertension, cardiac arrest. In the study, neurological side effects such as glasgow coma scale impairment and convulsions will be recorded.	2 hours
Secondary	Electrocardiography	Participants will be monitored with electrocardiography during the procedure and 2 hours following it.	3 hours
Secondary	SPO2	Participants will be monitored with pulse oximetry during the procedure and 2 hours following it.	3 hours
Secondary	Caphnography	Participants will be monitored with capnograph during the procedure and 2 hours following it.	3 hours
Secondary	Temperature Monitoring	Participants will be monitored with temperature probe during the procedure and 2 hours following it.	3 hours
Secondary	Systolic and Diastolic blood pressure	Participants will be monitored with blood pressure monitoring during the procedure and 2 hours following it.	3 hours
Secondary	Glasgow Coma Scale	Participants will be followed with glaskow coma scale during the procedure and 2 hours following it. Minimum value is 3 and maximum value is 15.	3 hours
Secondary	Aldrete Score	Participants will be assessed for recovery using the Aldrete score during the 2-hour follow-up period after the procedure. Minimum value is 0 and maximum value is 10.	2 hours