An interventional study of daily interruption of sedatives in Critical Illness, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged Up to 12 Years. Per ClinicalTrials.gov, last updated 2010-08-24.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 30 is below the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Inclusion Criteria:
Exclusion Criteria:
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
This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center