Effects of Daily Interruption of Sedatives in Critically Ill Children

Critical Illness Clinical Trial

Official title:

Effects of Daily Interruption of Sedatives in Critically Ill Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441506
• Other study ID #: PP04
• Status: Completed
• Phase: N/A
• First received: February 28, 2007
• Last updated: August 23, 2010
• Start date: November 2004
• Est. completion date: July 2006

Study information

• Verified date: February 2007
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• daily interruption of sedatives

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of (near) incidents		Until extubation or 28 days
Primary	total amount of sedatives administered		Until extubation or 28 days
Primary	time to wake up (after sedation is stopped), comfort scale		Until extubation or 28 days
Primary	BIS monitoring		Until extubation or 28 days
Secondary	time on ventilator		Until extubation or 28 days
Secondary	LOS on ICU		Until extubation or 28 days