Clinical trial NCT00441506: 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
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: interruption
critically ill
sedation
pediatrics
critically ill, ventilated children
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2007-03-01
Enrollment: 30
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: amount of (near) incidents
timeFrame: Until extubation or 28 days
measure: total amount of sedatives administered
timeFrame: Until extubation or 28 days
measure: time to wake up (after sedation is stopped), comfort scale
timeFrame: Until extubation or 28 days
measure: BIS monitoring
timeFrame: Until extubation or 28 days
Secondary outcomes:
measure: time on ventilator
timeFrame: Until extubation or 28 days
measure: LOS on ICU
timeFrame: Until extubation or 28 days
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Peter Pickkers, MD, PhD
role: STUDY_DIRECTOR
References: