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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reduce Pediatric Sedation to Reduce Mechanical Ventilation Complication in ICU

NCT02040168

Mechanical Ventilation Complication

COMPLETED

Implementation of an Analgesia-sedation Algorithm in the Pediatric ICU to Reduce Benzodiazepine Use

NCT04263662

Mechanical Ventilation Sedation

COMPLETED

Pilot Study for Sedation Interruption in Children

NCT02426320

Daily Sedative Interruption Sedation Strategies Sedation Protocols +2 more

UNKNOWN NA

Sedation Management in Pediatric Patients Supported on Mechanical Ventilation

NCT00142766

Respiratory Failure

COMPLETED PHASE2

Mortality in Pediatric Intensive Care Unit

NCT02961153

Intensive Care Units, Pediatric

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Analgesia Deep Sedation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group 1 : pre implementation group

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.

No interventions assigned to this group

group 2 : post implementation group

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.

Nurse-driven sedation protocol

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nurse-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.

Intervention Type BEHAVIORAL