Protocolized Sedation vs Usual Care in Pediatric Patients Mechanically Ventilated for Acute Respiratory Failure

Kevin Shores, PharmD candidate 2015, Mercer University College of Pharmacy

Acute respiratory failure is an emergency situation often involving the intensive care unit, caused when insufficient oxygen passes into ones blood stream. This lack of oxygen disrupts normal organ function and can cause damage. In adults, there are evidence-based guidelines that indicate protocol sedation when treating a patient with acute respiratory failure. However, in pediatric patients there is less proven evidence regarding what type of care is best.

A recently published study addressed this lack of evidence on protocol sedation versus usual pediatric care.2

Title: Protocolized Sedation vs Usual Care in Pediatric Patients Mechanically Ventilated for Acute Respiratory Failure: A Randomized Clinical Trial
Design Unblinded, multicenter, cluster randomized trial conducted in 31 US pediatric intensive care units; 2449 participants
Objective To determine whether critically ill children managed with a nurse-implemented, goal-directed sedation protocol experience fewer days of mechanical ventilation than patients receiving usual care
Study Groups Group 1 – 17 Intervention pediatric ICU’s

Group 2 – 14 Control pediatric ICU’s

Methods Intervention pediatric ICUs used a protocol that included targeted sedation, arousal assessments, extubation readiness testing, sedation adjustment every 8 hours, and sedation weaning through the use of a nurse-implemented, goal-directed comfort algorithm to guide sedation therapy. Control pediatric ICUs managed sedation per usual care.
Duration June 2009 to December 2013
Primary outcome measure The primary outcome was duration of mechanical ventilation.
Baseline Characteristics Age: Sedation protocol – 1.4; usual care – 2.6 (p=0.002)

Female: Sedation protocol – 558 (46%); usual care – 543 (44%)

Baseline Pediatric Overal Performance Category (POPC) score of 1: Sedation protocol – 558 (46%); usual care – 543 (44%)

Results Average duration of mechanical ventilation (p=0.61)

Intervention group – 6.5 days

Control group – 6.5 days

Adverse Events Adverse events reported: N/A
Serious adverse events: N/A
Adverse events that led to trial discontinuation: N/A
Study Author Conclusions Among children undergoing mechanical ventilation for acute respiratory failure, the use of a sedation protocol compared with usual care did not reduce the duration of mechanical ventilation.

This study was able to reveal some evidence to be evaluated in the matter of protocol sedation in pediatric patients with acute respiratory failure. More specifically, the results show a lack of significant improvement in the primary outcome of duration of mechanical ventilation. Despite this, however, those patients who received protocol sedation had significantly fewer days with opioid administration and were significantly more awake and alert while intubated. This points towards potential use from physicians who may be wanting to either use less opioids or keep their patient more awake and alert. Overall, the process still requires further investigation to carry enough weight to be conclusive, but hopefully this can be the first step in finding alternatives to treating this life threatening condition.


  1. Respiratory Failure: MedlinePlus.”S National Library of Medicine. U.S. National Library of Medicine. Accessed March 4, 2015
  2. Curley, M., D. Wypij, and S. Watson. “Protocolized Sedation vs Usual Care in Pediatric Patients Mechanically Ventilated for Acute Respiratory Failure.” 2015;313(4):379-389. doi:10.1001/jama.2014.18399.

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