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Effects of Daily Interruption of Sedatives in Critically Ill Children

Effects of Daily Interruption of Sedatives in Critically Ill Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00441506
Enrollment
30
Registered
2007-03-01
Start date
2004-11-30
Completion date
2006-07-31
Last updated
2010-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

interruption, critically ill, sedation, pediatrics, critically ill, ventilated children

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.

Interventions

DRUGdaily interruption of sedatives

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
BIS monitoringUntil extubation or 28 days
amount of (near) incidentsUntil extubation or 28 days
total amount of sedatives administeredUntil extubation or 28 days
time to wake up (after sedation is stopped), comfort scaleUntil extubation or 28 days

Secondary

MeasureTime frame
time on ventilatorUntil extubation or 28 days
LOS on ICUUntil extubation or 28 days

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026