The Incidence and Nature of Adverse Events During Pediatric Sedation for MRI/CT in One Korean University Hospital: Prospective Study
1 other identifier
observational
2,948
1 country
1
Brief Summary
Sedation and anesthesia for which to perform diagnostic imaging represents a rapidly growing field of practice, especially in children. Propofol is the most common sedative drug administered for MRI/CT. However, this drug is associated with adverse events, including pulmonary complications, and there has been no report on these complications in Korea. In this prospective observation study, the investigators will report the nature and frequency of adverse events associated with propofol-based sedation for MRI/CT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 9, 2013
CompletedFirst Posted
Study publicly available on registry
May 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedJanuary 21, 2015
January 1, 2015
2 years
May 9, 2013
January 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of Adverse Events
The investigators will record all adverse events that are associated with pediatric sedation for MRI/CT
24 hours
Study Arms (1)
sedation group
Children requiring sedation for MRI/CT
Interventions
When a patient is admitted to the Pediatric Sedation Center, a presedation assessment is performed by hospitalists. Then Pediatric sedation is performed by protocol in the sedation unit. Data on demographics, primary illness, ASA, snoring history, URI symptom, medications used, procedure and recovery times, medication doses, outcomes of anesthesia, airway interventions and adverse events will be reported.
Eligibility Criteria
Children requiring sedation for MRI/CT
You may qualify if:
- Requiring sedation for MRI/CT, aged 0- 18 years
You may not qualify if:
- Parent refusal of participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, Seoul, 120-752, South Korea
Related Publications (1)
Cravero JP, Beach ML, Blike GT, Gallagher SM, Hertzog JH; Pediatric Sedation Research Consortium. The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium. Anesth Analg. 2009 Mar;108(3):795-804. doi: 10.1213/ane.0b013e31818fc334.
PMID: 19224786BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2013
First Posted
May 16, 2013
Study Start
November 1, 2012
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
January 21, 2015
Record last verified: 2015-01