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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02829710
Acronym
SEDATIDE
Enrollment
200
Registered
2016-07-12
Start date
2013-01-31
Completion date
2015-04-30
Last updated
2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Deep Sedation

Keywords

Analgesia, intensive care units, clinical protocol, deep sedation, nursing assessment

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.

Interventions

BEHAVIORALNurse-driven sedation protocol

The nurse-driven sedation protocol included the COMFORT-B scale. Initial doses were chosen by the physicians then all changes were made by the nurses with the aim of attaining an optimal range of analgesia and sedation, which was defined as values from 11 to 17 on the COMFORT-B score.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Patients with tracheostomy

Design outcomes

Primary

MeasureTime frame
Duration of mechanical ventilation (days)Over the PICU stay of each child (Day 5)

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026