Effects of Daily Interruption of Sedatives in Critically Ill Children

NCT ID: NCT00441506

Last Updated: 2010-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2006-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

daily interruption of sedatives

Intervention Type: DRUG

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

• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Peter Pickkers, MD, PhD

Role: STUDY_DIRECTOR

Radboud University Medical Center

Locations

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

PP04

Identifier Type: -

Identifier Source: org_study_id