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Clinical Trials/NCT02829710
NCT02829710
Completed
Not Applicable

Implementation and Evaluation of a Paediatric Nurse-driven Sedation Protocol in a Paediatric Intensive Care Unit

Hospices Civils de Lyon1 site in 1 country200 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Analgesia
Sponsor
Hospices Civils de Lyon
Enrollment
200
Locations
1
Primary Endpoint
Duration of mechanical ventilation (days)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Management of analgesia and sedation is an integral component of the medical care of a critically-ill child. Its role is to assure comfort and safety to a patient undergoing painful cares and technical procedures; it can also be, in particular situations like acute respiratory distress syndrome or acute brain injury, a full processing treatment.

Sedation involves, most of the time, the association of an opioid and a sedative. The use of these drugs is difficult in children, because of a specific metabolism, inducing tolerance and withdrawal in case of prolonged administration.

The COMFORT-BEHAVIOR (COMFORT-B) scale is a validated, simple, reliable and reproducible score evaluating sedation and analgesia. Sedation scoring systems must be used regularly to avoid inadequate sedation.

Excessive sedation is associated with poor outcomes like prolonged mechanical ventilation, longer hospitalisation and more frequent withdrawal symptoms. Adult and paediatric data suggest that goal-directed sedation algorithms allow a more appropriate adaptation of the treatment to the patient's need and permit a reduction in the duration of mechanical ventilation.

The objective was to evaluate the impact of a nurse-driven sedation protocol in a paediatric intensive care unit on duration of mechanical ventilation, total doses and duration of medications, Paediatric Intensive Care Unit (PICU) length of stay, incidence of ventilator-associated-pneumonia and occurrence of withdrawal.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
April 2015
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Mechanically-ventilated patients aged from 0 to 18 years receiving sedation for more than 24 hours

Exclusion Criteria

  • Patients with tracheostomy

Outcomes

Primary Outcomes

Duration of mechanical ventilation (days)

Time Frame: Over the PICU stay of each child (Day 5)

Secondary Outcomes

  • Length of PICU stay (days)(Over the PICU stay of each child (Day 5))
  • Occurrence of withdrawal symptoms(Over the PICU stay of each child (Day 5))
  • Total doses of sedatives (unit/kg)(Over the PICU stay of each child (Day 5))

Study Sites (1)

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