Effects of Daily Interruption of Sedatives in Critically Ill Children
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00441506 |
Recruitment Status
:
Completed
First Posted
: March 1, 2007
Last Update Posted
: August 24, 2010
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | February 28, 2007 | |||
First Posted Date ICMJE | March 1, 2007 | |||
Last Update Posted Date | August 24, 2010 | |||
Study Start Date ICMJE | November 2004 | |||
Actual Primary Completion Date | June 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE |
|
|||
Change History | Complete list of historical versions of study NCT00441506 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
|
|||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Effects of Daily Interruption of Sedatives in Critically Ill Children | |||
Official Title ICMJE | Effects of Daily Interruption of Sedatives in Critically Ill Children | |||
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 2.4 days as well as a reduction in average ICU length of stay of 3.5 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. |
|||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Critical Illness | |||
Intervention ICMJE | Drug: daily interruption of sedatives | |||
Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
30 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | July 2006 | |||
Actual Primary Completion Date | June 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | up to 12 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Netherlands | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00441506 | |||
Other Study ID Numbers ICMJE | PP04 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Radboud University | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Radboud University | |||
Verification Date | February 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |