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. Identifier: NCT00441506
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : August 24, 2010
Information provided by:
Radboud University

February 28, 2007
March 1, 2007
August 24, 2010
November 2004
June 2006   (Final data collection date for primary outcome measure)
  • 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 ]
  • amount of (near) incidents
  • total amount of sedatives administered
  • time to wake up (after sedation is stopped), comfort scale
  • BIS monitoring
Complete list of historical versions of study NCT00441506 on Archive Site
  • time on ventilator [ Time Frame: Until extubation or 28 days ]
  • LOS on ICU [ Time Frame: Until extubation or 28 days ]
  • time on ventilator
  • LOS on ICU
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Effects of Daily Interruption of Sedatives in Critically Ill Children
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.

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Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Critical Illness
Drug: daily interruption of sedatives
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2006
June 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 12 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
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Radboud University
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Study Director: Peter Pickkers, MD, PhD Radboud University
Radboud University
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP