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Implementation and Evaluation of a Pediatric Nurse-driven Sedation Protocol in a PICU (SEDATIDE)

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Civil Hospices of Lyon

Status

Completed

Conditions

Deep Sedation
Analgesia

Treatments

Behavioral: Nurse-driven sedation protocol

Study type

Observational

Funder types

Other

Identifiers

NCT02829710
69HCL15_0312

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Patients with tracheostomy

Trial design

200 participants in 2 patient groups

group 1 : pre implementation group
Description:
All children aged less than 18 years, requiring mechanical ventilation for at least 24 hours and admitted in PICU between January 2013 and December 2013. Prior to implementation of the protocol, analgesia and sedation were managed by the attending physician's order.
group 2 : post implementation group
Description:
All children aged less than 18 years, requiring mechanical ventilation for at least 24 hours and admitted in PICU between May 2014 and March 2015. Nurses managed analgesia and sedation following an algorithm, including COMFORT-B scale.
Treatment:
Behavioral: Nurse-driven sedation protocol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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