Recruiting
Phase 3

Dexmedetomidine vs. Midazolam

Sponsor:

Douglas Fraser

Code:

NCT04082767

Conditions

Mechanically Ventilated, Critically Ill Children

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Precedex

Midazolam

Study Details

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

Study ID

NCT04082767

Start date

Jun 8, 2021

Status verified date

Dec, 2023

Completion date

Sep, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Dexmedetomidine

active comparator: Midazolam

Interventions

Precedex

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

Midazolam

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

Primary outcome measure

  • Target Sedation Range [ Time Frame: Up to 14 days post-randomization ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital - London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Principal Investigator:

Douglas D Fraser, MD/PhD

More Information

Sponsor

Douglas Fraser

Last update posted

Dec 11, 2023

Last verified

Dec, 2023

Keywords

  • sedation, delirium, pediatric, critical care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Douglas Fraser on 2023-12-11.