CARE--Childhood Awareness and Recall Evaluation
Completed
Conditions studied: Anesthesia
In brief
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-operative recall during general anesthesia. The hypothesis is that the implementation of routine awareness follow-up evaluation in children undergoing general anesthesia will identify that the incidence of intra-operative awareness in children is equal to or greater than in adults.
Key facts
- Study ID
- NCT00308984
- Run by
- Medtronic - MITG
- People needed
- 1784
- Starts
- 2006-01-01
- Expected to finish
- 2008-05-01
- Last updated by the study team
- 2012-03-07
Who can join
Age: 5 and older, up to 15. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The Children's Hospital, University of Colorado School of Medicine — Denver, Colorado, United States
- Children's Hospital of Atlanta at Egleston, Emory University — Atlanta, Georgia, United States
- Mott Children's Hospital, University of Michigan Health System — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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