Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Effects of Daily Interruption of Sedatives in Critically Ill Children
This study is currently recruiting participants.
Verified by Radboud University, February 2007
Sponsored by: Radboud University
Information provided by: Radboud University
ClinicalTrials.gov Identifier: NCT00441506
  Purpose

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
Critically Ill, Ventilated Children
Drug: daily interruption of sedatives

U.S. FDA Resources
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

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • amount of (near)incidents
  • total amount of sedatives administered
  • time to wake up (after sedation is stopped), comfort scale
  • BIS monitoring

Secondary Outcome Measures:
  • time on ventilator
  • LOS on ICU

Estimated Enrollment: 30
Study Start Date: November 2004
Estimated Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • · Intubated and mechanically ventilated for > 24 hours

    • Expectation further mechanically 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
    • ife expectancy less than a month / infaust prognosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00441506

Contacts
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

Locations
Netherlands, Gelderland
Radboud University Nijmegen Medical Center Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Investigators
Study Director: Peter Pickkers, MD, PhD Radboud University
  More Information

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)

Keywords provided by Radboud University:
interruption
critically ill
sedation
pediatrics

Study placed in the following topic categories:
Critical Illness

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009