MedTrace Logo

Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents

NCT05867472 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-04

No results posted yet for this study

Summary

The goal of a pilot study is to test a study plan to see if it is appropriate for a larger study. This study plan is looking at whether the use of inhaled sedatives (medications that help people be calm and sleep) can reduce delirium (extreme confusion) in children who need a ventilator (breathing machine) compared to IV or oral sedatives.

The main question\[s\] it aims to answer are:

* Will people join the study? (recruitment)
* Will participants finish the study?
* Will healthcare teams accept the study procedures?

Participants will be randomized to receive study treatment (inhaled sedation) or standard of care (IV sedation). They will be monitored daily for up to 28 days. They will complete memory, thinking and behaviour tasks after 9-12 months.

Conditions

  • Intensive Care Units, Pediatric
  • Anesthetics, Inhalation
  • Mechanically Ventilated, Critically Ill Children

Interventions

DRUG

Isoflurane Inhalant Product

Isoflurane will be administered using an inhalation device

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Angela Jerath, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2026-05-31
Completion
2026-12-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05867472 on ClinicalTrials.gov