Sedation Efficacy of Dexmedetomidine Versus Midazolam in Critically Ill Ventilated Children

NCT04082767 | Unknown Phase 3

• 1 other identifier: PEDSED01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

There is a significant lack of adequately powered randomized clinical trial (RCT) data to determine the comparative safety and effectiveness of sedative treatments in pediatric patients. In many centres the standard of care for sedation in pediatric critical care unit (PCCU) patients includes the use of benzodiazepines despite the known negative effects of increased patient agitation and delirium, which can contribute to longer PCCU and hospital length of stay (LOS). The use of an alternative sedative, dexmedetomidine may reduce negative effects in this population. As such, the investigators plan to conduct a well designed comparative RCT to determine the most effective and safest sedative in this vulnerable population utilizing clinical assessments of sedation levels and delirium instance, electroencephalography (EEG) analysis and patient important outcomes.

Conditions

Mechanically Ventilated, Critically Ill Children

Keywords

sedation, delirium, pediatric, critical care

Outcome Measures

Primary Outcomes (1)

• Target Sedation Range

  The percentage of time spent within target sedation range, defined as COMFORT Behaviour Scale score of 11-22, which will be assessed at minimum every 4 hours.

  Up to 14 days post-randomization

Secondary Outcomes (13)

• Delirium

  Up to 14 days post-randomization

• Delirium

  Up to 14 days post-randomization

• Delirium

  Up to 14 days post-randomization

• Delirium

  Up to 14 days post-randomization

• Duration of mechanical ventilation

  Up to 28 days post-randomization

Other Outcomes (1)

• Economic Analysis

  Up to 90 days post-randomization

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Drug: Precedex

Midazolam

ACTIVE COMPARATOR

Drug: Midazolam

Interventions

Precedex DRUG

Precedex, dexmedetomidine hydrochloride, IV, 4mcg/mL, infusion duration determined by the clinical care team

Also known as: dexmedetomidine

Dexmedetomidine

Midazolam DRUG

Midazolam, IV, 5mg/mL (for patients more than 10kg), 1mg/mL (for patients 2-10kg), infusion duration determined by the clinical care team

Midazolam

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Admission is a consequence of suspected or proven drug overdose
• Patient is receiving dialysis
• Known pregnancy or lactation
• Neuromuscular blockade other than for intubation
• General anesthesia in the 24 hours prior to study initiation
• 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
• Acute hepatitis or severe liver disease
• Known history of sensitivity to midazolam and/or dexmedetomidine or their constituents
• Systolic blood pressure (SBP) below 5th percentile for two consecutive measurements
• Heart rate (HR) below 5th percentile for two consecutive measurements
• 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
• Previous enrollment into the study

Sponsors & Collaborators

• Douglas Fraser: lead

Study Sites (1)

Children's Hospital - London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Douglas D Fraser, MD., PhD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maysaa Assaf, BSc

CONTACT

519-685-8500; maysaa.assaf@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Paediatric Intensivist

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 9, 2019
• Study Start: June 8, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)