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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06467045
Enrollment
500
Registered
2024-06-20
Start date
2024-06-24
Completion date
2024-10-05
Last updated
2024-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effect, Magnetic Resonance Imaging, Pediatric Anesthesia, Sedation

Keywords

pediatric, adverse effects, magnetic resonance imaging, sedation, anesthesia

Brief 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.

Interventions

OTHERPediatric 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.

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 16 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Perioperative adverse events1 hoursIn 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.
Postoperative adverse events2 hoursIn 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.

Secondary

MeasureTime frameDescription
Caphnography3 hoursParticipants will be monitored with capnograph during the procedure and 2 hours following it.
Temperature Monitoring3 hoursParticipants will be monitored with temperature probe during the procedure and 2 hours following it.
Electrocardiography3 hoursParticipants will be monitored with electrocardiography during the procedure and 2 hours following it.
Glasgow Coma Scale3 hoursParticipants will be followed with glaskow coma scale during the procedure and 2 hours following it. Minimum value is 3 and maximum value is 15.
Aldrete Score2 hoursParticipants 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.
Systolic and Diastolic blood pressure3 hoursParticipants will be monitored with blood pressure monitoring during the procedure and 2 hours following it.
SPO23 hoursParticipants will be monitored with pulse oximetry during the procedure and 2 hours following it.

Countries

Turkey (Türkiye)

Contacts

Primary ContactKubra OZTURK
kubrizt@hotmail.com0905385078036
Backup ContactAyse Surhan CINAR
asurhan@yahoo.com0905326850929

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026