Effects of Daily Interruption of Sedatives in Critically Ill Children
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Daily Interruption of Sedatives in Critically Ill Children|
- amount of (near) incidents [ Time Frame: Until extubation or 28 days ]
- total amount of sedatives administered [ Time Frame: Until extubation or 28 days ]
- time to wake up (after sedation is stopped), comfort scale [ Time Frame: Until extubation or 28 days ]
- BIS monitoring [ Time Frame: Until extubation or 28 days ]
- time on ventilator [ Time Frame: Until extubation or 28 days ]
- LOS on ICU [ Time Frame: Until extubation or 28 days ]
|Study Start Date:||November 2004|
|Study Completion Date:||July 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00441506
|Radboud University Nijmegen Medical Center|
|Nijmegen, Gelderland, Netherlands, 6500HB|
|Study Director:||Peter Pickkers, MD, PhD||Radboud University|