Comparing sedation methods for critically ill children on ventilators

Sedation Efficacy of Dexmedetomidine Versus Midazolam in Critically Ill Ventilated Children

This study is testing two different sedatives for critically ill children on ventilators to see which one is safer and helps them feel more comfortable.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 1 Month to 17 Years
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (Academic / other)
• Locations: 1 site (London, Ontario)
• Trial ID: NCT04082767 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the safety and effectiveness of two sedatives, dexmedetomidine and midazolam, in mechanically ventilated children aged 1 month to 18 years. The study will assess sedation levels, instances of delirium, and other important patient outcomes using clinical assessments and electroencephalography (EEG) analysis. By evaluating these sedative treatments, the trial seeks to identify a safer alternative that may reduce agitation and delirium, ultimately improving patient care in pediatric critical care units.

Who should consider this trial

Good fit: Ideal candidates are critically ill children aged 1 month to 18 years who are intubated and require sedation for at least 48 hours.

Not a fit: Patients with conditions such as drug overdose, severe liver disease, or those requiring neuromuscular blockade may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved sedation practices in critically ill children, reducing complications and hospital stays.

How similar studies have performed: Other studies have indicated the potential benefits of dexmedetomidine in pediatric sedation, suggesting this approach may be promising.

Eligibility criteria

Inclusion Criteria:

1. Age is 1 month to 18 years inclusive
2. The patient is intubated and is expected to remain intubated for at least the next 48 hours
3. The patient has not been receiving mechanical ventilation for more than 72 hours
4. The patient must already be receiving an opioid infusion per PCCU Guidelines for Sedation \& Analgesia for Procedures Outside O.R. and need additional sedation.

Exclusion Criteria:

1. Admission is a consequence of suspected or proven drug overdose
2. Patient is receiving dialysis
3. Known pregnancy or lactation
4. Neuromuscular blockade other than for intubation
5. General anesthesia in the 24 hours prior to study initiation
6. An acquired Central Nervous System (CNS) condition (i.e. encephalitis, traumatic brain injury) resulting in ongoing dysfunction or an acquired condition resulting in ongoing dysfunction
7. Acute hepatitis or severe liver disease
8. Known history of sensitivity to midazolam and/or dexmedetomidine or their constituents
9. Systolic blood pressure (SBP) below 5th percentile for two consecutive measurements
10. Heart rate (HR) below 5th percentile for two consecutive measurements
11. Death is deemed to be imminent or inevitable during the admission and either the intensivist or substitute decision maker is not committed to full active resuscitation
12. Previous enrollment into the study

Where this trial is running

London, Ontario

• Children's Hospital - London Health Sciences Centre — London, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Douglas D Fraser, MD., PhD — London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
• Study coordinator: Maysaa Assaf, BSc

Conditions Mechanically Ventilated, Critically Ill Children; sedation, delirium, pediatric, critical care