Effects of Daily Interruption of Sedatives in Critically Ill Children

NCT00441506 | Completed

• 1 other identifier: PP04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

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

Outcome Measures

Primary Outcomes (4)

• amount of (near) incidents

  Until extubation or 28 days

• total amount of sedatives administered

  Until extubation or 28 days

• time to wake up (after sedation is stopped), comfort scale

  Until extubation or 28 days

• BIS monitoring

  Until extubation or 28 days

Secondary Outcomes (2)

• time on ventilator

  Until extubation or 28 days

• LOS on ICU

  Until extubation or 28 days

Interventions

daily interruption of sedatives DRUG

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Pickkers, MD, PhD

  Radboud University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 1, 2007
• Study Start: November 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: July 1, 2006
• Last Updated: August 24, 2010

Record last verified: 2007-02

Locations

NL (1)