Status:
COMPLETED
CARE--Childhood Awareness and Recall Evaluation
Lead Sponsor:
Medtronic - MITG
Conditions:
Anesthesia
Eligibility:
All Genders
5-15 years
Brief Summary
The purpose of this study is to describe the incidence of recall or awareness under anesthesia in children aged 5-15 by collecting anesthetic and post-operative follow-up data relating to intra-operat...
Detailed Description
Awareness, or the unwanted recall of intra-operative events occurring during general anesthesia, is a potentially avoidable anesthetic complication that poses the risk for psychological sequelae. Whil...
Eligibility Criteria
Inclusion
- Children 5-15 years of age scheduled for a surgical procedure that requires general anesthesia.
- Children able to respond to and answer post-operative follow-up questions at 3 time intervals post anesthesia: prior to discharge from the post-operative recovery area (or within the first 24 hours following surgery as clinically indicated), 3 (+ 1) days and 14 (+ 2) days post-operatively.
- Ability to speak and understand English.
- Anticipated length of general anesthesia of at least 30 minutes.
Exclusion
- Children with known cognitive or neurologic impairment, psychiatric illness or developmental delay consistent with inability to accurately or adequately respond to or answer post-operative follow-up recall questions relating to their anesthesia experience.
- Expectation that the child will remain endotracheally intubated beyond 24 hours postoperatively.
- Anticipated use of ketamine for anesthetic management.
- Children that have had surgery or general anesthesia within the past 6 months or it is anticipated that child will require additional surgeries within the 14 day study follow-up time period.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
1784 Patients enrolled
Trial Details
Trial ID
NCT00308984
Start Date
January 1 2006
End Date
May 1 2008
Last Update
March 7 2012
Active Locations (3)
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1
The Children's Hospital, University of Colorado School of Medicine
Denver, Colorado, United States, 80218
2
Children's Hospital of Atlanta at Egleston, Emory University
Atlanta, Georgia, United States, 30322
3
Mott Children's Hospital, University of Michigan Health System
Ann Arbor, Michigan, United States, 48109