Protocolized Sedative Weaning VS. Usual Care in Pediatric Critically Ill, RCT

Overview

Sedative and analgesic agents are widely used in the ICU. These agents can provide hypnotic effect, pain alleviation, cooperation, and synchronizing ventilatory support. Prolonged use of the agents can lead to withdrawal symptoms when the drugs are weaned. Prior study showed the longer duration of sedative drugs, cumulative dose of medications and younger age were the risk factors of withdrawal syndrome. Additional, some study showed the sedation protocol can reduce the incidence of withdrawal syndrome. However, no worldwide standardized sedative weaning protocol including our hospital. The objectives in this study are to establish the sedative weaning protocol and to compare the protocol sedative weaning with the usual care weaning.

Full Title of Study: “Protocolized Sedative Weaning Versus Usual Care in Pediatric Critically Ill, Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2018

Detailed Description

Sedative and analgesic agents, particularly benzodiazepines and opioids, are widely used in PICU. These agents can provide calmness, hypnotic effect, pain alleviation, cooperation, immobilization and synchronizing ventilatory support. Prolonged use of the agents can lead to withdrawal symptoms when the drugs are weaned. Incidence of withdrawal syndrome is about 50%. Withdrawal syndrome can lead to unnecessary and costly diagnostic tests, prolongation of mechanical ventilation and hospital stay, and increasing of suffering. Prior study showed the longer duration of sedative drugs, cumulative dose of medications and younger age were the risk factors of withdrawal syndrome. Additional, some study showed the sedation protocol can reduce the incidence of withdrawal syndrome. However, no worldwide standardized sedative weaning protocol including our hospital.

Interventions

  • Other: The sedative weaning protocol group
    • After physician decide to wean sedative or analgesic drugs. We divided to 2 groups including high risk group and low risk group. The sedative weaning protocol were used in these patients which rely on the high risk or low risk group.
  • Other: The usual group
    • After physician decide to wean sedative or analgesic drugs. The sedative/analgesic drugs were weaned depend on physician

Arms, Groups and Cohorts

  • Active Comparator: Sedative weaning protocol
    • We create the new sedative weaning protocol and then use the sedative weaning protocol.
  • Placebo Comparator: Usual Care
    • no use sedative weaning protocol. Sedative or/and analgesic medications are adjusted base on physician

Clinical Trial Outcome Measures

Primary Measures

  • incidence of withdrawal symptom
    • Time Frame: 72 hour

Secondary Measures

  • length of PICU stay
    • Time Frame: 30 days
  • sedation related adverse events
    • Time Frame: 7 days

Participating in This Clinical Trial

Inclusion Criteria

  • Patients aged 1 mo to 18 yrs, at least 37 week of postmenstrual age – Patient who was admitted in PICU or intermediate ward at Ramathibodi hospital – use analgesic/sedative drugs (parenteral)≥ 3 days Exclusion Criteria:

  • Patients in whom level of sedation or withdrawal assessment cannot be scored. – Patients transferred from other hospitals in which the patients have already presented of withdrawal symptoms – patient/parent refuse this study

Gender Eligibility: All

Minimum Age: 1 Month

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ramathibodi Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nattachai Anantasit, Assistant Professor – Ramathibodi Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.