Effects of Daily Interruption of Sedatives in Critically Ill Children

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00441506
First received: February 28, 2007
Last updated: August 23, 2010
Last verified: February 2007

February 28, 2007
August 23, 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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Critical Illness
Drug: daily interruption of sedatives
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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
Both
up to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00441506
PP04
No
Not Provided
Radboud University
Not Provided
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