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

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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

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.


Condition or disease Intervention/treatment
Children Requiring Sedation for MRI/CT Drug: pediatric sedation (propofol, ketamine, etc)

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Study Type : Observational
Estimated Enrollment : 3739 participants
Time Perspective: Retrospective
Study Start Date : November 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
sedation group
Children requiring sedation for MRI/CT
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.





Primary Outcome Measures :
  1. Frequency of Adverse Events [ Time Frame: 24 hours ]
    The investigators will review all adverse events that are associated with pediatric sedation for MRI/CT



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children requiring sedation for MRI/CT
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855581


Locations
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Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Eun Mi Kim    82-2-2227-3552    med0204@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01855581     History of Changes
Other Study ID Numbers: 4-2012-0923
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: May 16, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
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Propofol
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action