Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial

Duangtip Tiacharoen1, Rojjanee Lertbunrian2, Jarin Veawpanich2

  • 1Division of Pediatric Critical Care, Department of Pediatrics, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Division of Pediatric Critical Care, Department of Pediatrics, Faculty of Medicine, Thammasat University Hospital, Pathumthani, Thailand.

Insights

A new sedative-weaning protocol in critically ill children reduced withdrawal days and intensive care unit stay duration. This pilot study suggests protocolized weaning is effective for pediatric patients on sedatives and analgesics.

Area of Science:

  • Pediatric Critical Care Medicine
  • Pharmacology
  • Clinical Trial Research

Background:

  • Prolonged use of benzodiazepines and opioids in critically ill children can increase withdrawal syndrome incidence.
  • Lack of a standardized sedative-weaning protocol is a known risk factor for withdrawal syndrome.
  • This study aimed to address this gap by establishing and evaluating a sedative-weaning protocol.

Purpose of the Study:

  • To establish a sedative-weaning protocol for high-risk critically ill children.
  • To compare the efficacy of this protocol against usual care in weaning children from sedative and analgesic drugs.
  • To determine the prevalence of withdrawal syndrome in both groups.

Main Methods:

  • An open-label, randomized controlled trial was conducted in a tertiary-care hospital.
  • Children aged 1 month to 18 years, receiving intravenous sedatives/analgesics for at least 5 days, were recruited.
  • Patients were randomized into a protocolized (intervention) group or usual care (control) group.

Main Results:

  • The prevalence of withdrawal syndrome was high in both groups (84% intervention vs. 81% control).
  • The intervention group showed a significantly shorter initial weaning phase duration (p=0.026).
  • Cumulative morphine rescue dose was significantly lower in the intervention group (p=0.016).

Conclusions:

  • Implementation of the sedative-weaning protocol significantly reduced withdrawal days and intensive care unit length of stay.
  • No adverse drug reactions were observed with the protocolized approach.
  • External validation is recommended to confirm the protocol's generalizability.
Abstract

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