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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01855581
Recruitment Status : Unknown
Verified May 2013 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : May 16, 2013
Last Update Posted : May 16, 2013
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date May 9, 2013
First Posted Date May 16, 2013
Last Update Posted Date May 16, 2013
Study Start Date November 2012
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2013)
Frequency of Adverse Events [ Time Frame: 24 hours ]
The investigators will review all adverse events that are associated with pediatric sedation for MRI/CT
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Incidence and Nature of Adverse Events During Pediatric Sedation for MRI/CT in One Korean University Hospital: Retrospective Study
Official Title Not Provided
Brief Summary

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 Not Provided
Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children requiring sedation for MRI/CT
Condition Children Requiring Sedation for MRI/CT
Intervention Drug: 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.

Study Groups/Cohorts sedation group
Children requiring sedation for MRI/CT
Intervention: Drug: pediatric sedation (propofol, ketamine, etc)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 13, 2013)
3739
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2013
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01855581
Other Study ID Numbers 4-2012-0923
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Yonsei University
Original Responsible Party Same as current
Current Study Sponsor Yonsei University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Yonsei University
Verification Date May 2013