Effects of Daily Interruption of Sedatives in Critically Ill Children

Study Overview
=================
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.

Official Title
-----------------
Effects of Daily Interruption of Sedatives in Critically Ill Children

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Drug: daily interruption of sedatives


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: daily interruption of sedatives|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time on ventilator |  | Until extubation or 28 days | 
| LOS on ICU |  | Until extubation or 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
interruption, critically ill, sedation, pediatrics, critically ill, ventilated children