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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT01855555

Collaborator

(none)

2,948

Enrollment

Location

Duration (Months)

122.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Children Requiring Sedation for MRI/CT	Drug: sedation with propofol

Study Design

Study Type:

Observational

Actual Enrollment :

2948 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
sedation group Children requiring sedation for MRI/CT	Drug: sedation with propofol 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.

Arm

Intervention/Treatment

sedation group

Children requiring sedation for MRI/CT

Drug: sedation with propofol

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Parent refusal of participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01855555

Other Study ID Numbers:

4-2012-0688

First Posted:

May 16, 2013

Last Update Posted:

Jan 21, 2015

Last Verified:

Jan 1, 2015

Additional relevant MeSH terms:

Propofol

Study Results

No Results Posted as of Jan 21, 2015