The Incidence and Nature of Adverse Events During Pediatric Sedation for MRI/CT in One Korean University Hospital: Prospective Study

Completed

• Conditions: Children Requiring Sedation for MRI/CT
• Interventions: Drug: sedation with propofol

• Registration Number: NCT01855555
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-05-09
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-16
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-18
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2948

Inclusion Criteria

• Requiring sedation for MRI/CT, aged 0- 18 years

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Exclusion Criteria

• Parent refusal of participation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sedation group	sedation with propofol	Children requiring sedation for MRI/CT

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events	24 hours	The investigators will record all adverse events that are associated with pediatric sedation for MRI/CT

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of