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

Completed

• Conditions: Deep Sedation; Analgesia

• Registration Number: NCT02829710
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Status Verified: 2016-06
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-07-08
• Last Update Submitted: 2016-07-08
• Study First Posted: 2016-07-12
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation (days)	Over the PICU stay of each child (Day 5)

Secondary Outcome Measures

Name	Time	Method
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)
Length of PICU stay (days)	Over the PICU stay of each child (Day 5)

Trial Locations

Locations (1)

service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon, 59 Boulevard Pinel; 🇫🇷 Bron, France