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Radboud University |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00441506 |
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 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-extubations, 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. We studied the effects of daily interruption of sedatives in critically ill children on the total amount of sedatives used and risks of complications.
Condition | Intervention |
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Critically Ill, Ventilated Children |
Drug: daily interruption of sedatives |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Daily Interruption of Sedatives in Critically Ill Children |
Estimated Enrollment: | 30 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | July 2006 |
Ages Eligible for Study: | up to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
· Intubated and mechanically ventilated for > 24 hours
Exclusion Criteria:
· Inclusion in another trial
Contact: Ger Heesen, RN, RCCN | 31-24-3617273 | g.heesen@ic.umcn.nl |
Contact: Peter Pickkers, MD, PhD | 31-24-3617273 ext 2378 | p.pickkers@ic.umcn.nl |
Netherlands, Gelderland | |
Radboud University Nijmegen Medical Center | Recruiting |
Nijmegen, Gelderland, Netherlands, 6500HB |
Study Director: | Peter Pickkers, MD, PhD | Radboud University |
Study ID Numbers: | PP04 |
Study First Received: | February 28, 2007 |
Last Updated: | February 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00441506 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
interruption critically ill sedation pediatrics |
Critical Illness |
Disease Attributes Pathologic Processes |