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

NCT01855581 | Unknown

• 1 other identifier: 4-2012-0923
• Study Type: observational
• Target: 3,739
• Locations: 1 country
• Sites: 1

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.

Conditions

Children Requiring Sedation for MRI/CT

Outcome Measures

Primary Outcomes (1)

• Frequency of Adverse Events

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

  24 hours

Study Arms (1)

sedation group

Children requiring sedation for MRI/CT

Drug: pediatric sedation (propofol, ketamine, etc)

Interventions

pediatric sedation (propofol, ketamine, etc) 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.

sedation group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children requiring sedation for MRI/CT

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 22177990 BACKGROUND

MeSH Terms

Interventions

Propofol; Ketamine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 16, 2013
• Study Start: November 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 16, 2013

Record last verified: 2013-05

Locations

KR (1)