Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441506
Status:
COMPLETED
Last Update Posted:
2010-08-24
First Post:
2007-02-28
Brief Title:
Effects of Daily Interruption of Sedatives in Critically Ill Children
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Effects of Daily Interruption of Sedatives in Critically Ill Children
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Critically ill children are often sedated in order to relieve them from anxiety and discomfort and to facilitate their care There is little information on the effects of prolonged and continuous use of sedatives and analgesic agents in critically ill children In adult intensive care unit ICU patients daily interruption of sedative infusions accelerates recovery resulting in a reduction in the average duration of mechanical ventilation of 24 days as well as a reduction in average ICU length of stay of 35 days These results were achieved without an increased rate of adverse events potentially linked to less sedation and associated with a reduction of common complications of critical illness and without negative psychological effects
It is unknown whether these results can be extrapolated to critically ill children Moreover the possible risk of complications associated with less sedation such as accidental self-extubation is probably higher in children Also the need for intermittent bolus administrations in children treated with intermittent sedation could nullify the reduction in the use of sedatives
It is unknown if daily interruption of sedatives is feasible in critically ill children The researchers studied the effects of daily interruption of sedatives in critically ill children on the total amount of sedatives used and risks of complications
It is unknown whether these results can be extrapolated to critically ill children Moreover the possible risk of complications associated with less sedation such as accidental self-extubation is probably higher in children Also the need for intermittent bolus administrations in children treated with intermittent sedation could nullify the reduction in the use of sedatives
It is unknown if daily interruption of sedatives is feasible in critically ill children The researchers studied the effects of daily interruption of sedatives in critically ill children on the total amount of sedatives used and risks of complications
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None