Actively Recruiting

Age: 0Days - 16Years
All Genders
ID06467045

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

Led by Sisli Hamidiye Etfal Training and Research Hospital · Updated on 2024-06-25

500

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to determine how often adverse effects occur and what factors influence them in children undergoing sedation for magnetic resonance imaging (MRI). Sedation is often necessary because children must remain still during MRI scans, which can be challenging due to the noisy and lengthy procedure. Pediatric anesthesia outside the operating room carries risks, especially since many children have other health issues or congenital conditions that may increase complications. The study is observational and focuses on sedation-related side effects in this setting. The study observes approximately 500 pediatric patients under 16 years old who undergo MRI with sedation, excluding those who are intubated. Researchers will collect information on patients' demographics, medical conditions, medications, the anesthesia drugs used, and the anesthesiologist's experience. All participants belong to one group receiving sedation during MRI; no treatment comparisons are made. The study period spans from June to September 2024. Participants will be monitored for any adverse events during and after sedation, including respiratory and cardiovascular issues. Assessments include electrocardiography, oxygen saturation, capnography, blood pressure, temperature monitoring, and neurological scales such as the Glasgow Coma Scale and Aldrete Score. Monitoring will continue for several hours after the procedure to track both immediate and postoperative side effects. The total observation helps researchers understand the frequency and causes of sedation-related adverse events in pediatric MRI settings.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0Days - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All non-intubated patients under the age of 16 were included in the study.
Not Eligible

You will not qualify if you...

  • Intubated pediatric patients were excluded.
  • Patients older than 16 years were excluded.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 3 hours

Participants who receive sedation for magnetic resonance imaging are observed for adverse events during and after the procedure.

1 visit (in-person) during and after MRI sedation

Trial Site Locations

Total: 1 location

1

Sisli Hamidiye Etfal Research and Training Hospital

Istanbul, Sarıyer, Turkey (Türkiye), 34060

Actively Recruiting

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Research Team

K

Kubra OZTURK

A

Ayse Surhan CINAR

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Incidence of severe critical events in paediatric anaesthesia (APRICOT): a prospective multicentre observational study in 261 hospitals in Europe.

Walid Habre, Nicola Disma, Katalin Virag...

https://pubmed.ncbi.nlm.nih.gov/28363725