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Effects of Daily Interruption of Sedatives in Critically Ill Children

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

Study Description
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.


Condition or disease Intervention/treatment
Critical Illness Drug: daily interruption of sedatives

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Daily Interruption of Sedatives in Critically Ill Children
Study Start Date : November 2004
Primary Completion Date : June 2006
Study Completion Date : July 2006
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. amount of (near) incidents [ Time Frame: Until extubation or 28 days ]
  2. total amount of sedatives administered [ Time Frame: Until extubation or 28 days ]
  3. time to wake up (after sedation is stopped), comfort scale [ Time Frame: Until extubation or 28 days ]
  4. BIS monitoring [ Time Frame: Until extubation or 28 days ]

Secondary Outcome Measures :
  1. time on ventilator [ Time Frame: Until extubation or 28 days ]
  2. LOS on ICU [ Time Frame: Until extubation or 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00441506


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

ClinicalTrials.gov Identifier: NCT00441506     History of Changes
Other Study ID Numbers: PP04
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: August 24, 2010
Last Verified: February 2007

Keywords provided by Radboud University:
interruption
critically ill
sedation
pediatrics
critically ill, ventilated children

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs