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OpenTrials
Completed

NCT Number: NCT00441506

Effects of Daily Interruption of Sedatives in Critically Ill Children

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.

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Key information

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6500HB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

daily interruption of sedatives

Drug

Primary outcomes

  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 outcomes

  1. time on ventilator

    Time frame: Until extubation or 28 days

  2. LOS on ICU

    Time frame: Until extubation or 28 days

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Mar 1, 2007
Registry last updated
Aug 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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