Effects of Daily Interruption of Sedatives in Critically Ill Children
Primary Purpose
Critical Illness
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
daily interruption of sedatives
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring interruption, critically ill, sedation, pediatrics, critically ill, ventilated children
Eligibility 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
Sites / Locations
- Radboud University Nijmegen Medical Center
Outcomes
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
Full Information
NCT ID
NCT00441506
First Posted
February 28, 2007
Last Updated
August 23, 2010
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00441506
Brief Title
Effects of Daily Interruption of Sedatives in Critically Ill Children
Official Title
Effects of Daily Interruption of Sedatives in Critically Ill Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
interruption, critically ill, sedation, pediatrics, critically ill, ventilated children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
daily interruption of sedatives
Primary Outcome Measure Information:
Title
amount of (near) incidents
Time Frame
Until extubation or 28 days
Title
total amount of sedatives administered
Time Frame
Until extubation or 28 days
Title
time to wake up (after sedation is stopped), comfort scale
Time Frame
Until extubation or 28 days
Title
BIS monitoring
Time Frame
Until extubation or 28 days
Secondary Outcome Measure Information:
Title
time on ventilator
Time Frame
Until extubation or 28 days
Title
LOS on ICU
Time Frame
Until extubation or 28 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Pickkers, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Radboud University Nijmegen Medical Center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500HB
Country
Netherlands
12. IPD Sharing Statement
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Effects of Daily Interruption of Sedatives in Critically Ill Children
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