Effects of Daily Interruption of Sedatives in Critically Ill Children

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; (submitted: August 23, 2010)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: February 28, 2007)	amount of (near) incidents; total amount of sedatives administered; time to wake up (after sedation is stopped), comfort scale; BIS monitoring
Change History	Complete list of historical versions of study NCT00441506 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 23, 2010)	time on ventilator [ Time Frame: Until extubation or 28 days ]; LOS on ICU [ Time Frame: Until extubation or 28 days ]
Original Secondary Outcome Measures ICMJE; (submitted: February 28, 2007)	time on ventilator; LOS on ICU
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; (submitted: February 28, 2007)	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: Intubated and mechanically ventilated for > 24 hours; Expect further mechanical ventilation for > 48 hours; Receiving midazolam and morphine for sedation; Written informed consent given by parents Exclusion Criteria: Inclusion in another trial; Transfer from an outside institution where sedatives had been administered; Neuromuscular blockers; Metabolic disease; Neuromuscular disease; Encephalopathy; Epilepsy; Pulmonary hypertension; Neurotrauma; Raised intracranial pressure; Life expectancy less than a month/infaust prognosis
Sex/Gender	Sexes Eligible for Study: All
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	Study Director: Peter Pickkers, MD, PhD Radboud University
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