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Sedation Efficacy of Dexmedetomidine Versus Midazolam in Critically Ill Ventilated Children

NCT ID: NCT04082767

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-08

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mechanically Ventilated, Critically Ill Children

Keywords

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sedation, delirium, pediatric, critical care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexmedetomidine

Group Type ACTIVE_COMPARATOR

Precedex

Intervention Type DRUG

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

Midazolam

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

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

Interventions

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Precedex

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

Intervention Type DRUG

Midazolam

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

Intervention Type DRUG

Other Intervention Names

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dexmedetomidine

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Douglas Fraser

OTHER

Sponsor Role lead

Responsible Party

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Douglas Fraser

Paediatric Intensivist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Douglas D Fraser, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Children's Hospital - London Health Sciences Centre

London, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Maysaa Assaf, BSc

Role: CONTACT

Phone: 519-685-8500

Email: [email protected]

Facility Contacts

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Maysaa Assaf, BSc

Role: primary

Other Identifiers

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PEDSED01

Identifier Type: -

Identifier Source: org_study_id