Completed

NCT Number: NCT01855555

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

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.

Completed

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Key information

Conditions

Children Requiring Sedation for MRI/CT

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Parent refusal of participation

Treatment and study plan

sedation with propofol

Drug

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.

Primary outcomes

Frequency of Adverse Events

Time frame: 24 hours

The investigators will record all adverse events that are associated with pediatric sedation for MRI/CT

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: May 16, 2013
Registry last updated: Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.