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

Analgesia Clinical Trial

— SEDATIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829710
• Other study ID #: 69HCL15_0312
• Status: Completed
• Phase: N/A
• First received: June 28, 2016
• Last updated: July 8, 2016
• Start date: January 2013
• Est. completion date: April 2015

Study information

• Verified date: June 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with tracheostomy

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Analgesia
• Deep Sedation

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
France	service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon, 59 Boulevard Pinel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of mechanical ventilation (days)		Over the PICU stay of each child (Day 5)	No
Secondary	Total doses of sedatives (unit/kg)		Over the PICU stay of each child (Day 5)	No
Secondary	Occurrence of withdrawal symptoms		Over the PICU stay of each child (Day 5)	No
Secondary	Length of PICU stay (days)		Over the PICU stay of each child (Day 5)	No