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

NCT ID: NCT01855581

Last Updated: 2013-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3739 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-10-31

Brief Summary

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Sedation and anesthesia for 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.

The investigators reviewed 3739 charts of pediatric patients sedated for MRI/CT between January and November 2012.

In this study, the investigators will report the nature and frequency of adverse events associated with sedation for MRI/CT between January and November 2012.

Detailed Description

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Conditions

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Children Requiring Sedation for MRI/CT

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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sedation group

Children requiring sedation for MRI/CT

pediatric sedation (propofol, ketamine, etc)

Intervention Type DRUG

Presedation assessment was performed by hospitalists and pediatric sedation was 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 were collected retrospectively.

Interventions

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pediatric sedation (propofol, ketamine, etc)

Presedation assessment was performed by hospitalists and pediatric sedation was 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 were collected retrospectively.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Eun Mi Kim

Role: primary

82-2-2227-3552

References

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Srinivasan M, Turmelle M, Depalma LM, Mao J, Carlson DW. Procedural sedation for diagnostic imaging in children by pediatric hospitalists using propofol: analysis of the nature, frequency, and predictors of adverse events and interventions. J Pediatr. 2012 May;160(5):801-806.e1. doi: 10.1016/j.jpeds.2011.11.003. Epub 2011 Dec 16.

Reference Type BACKGROUND
PMID: 22177990 (View on PubMed)

Other Identifiers

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4-2012-0923

Identifier Type: -

Identifier Source: org_study_id

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