Status:
UNKNOWN
Sedation Efficacy of Dexmedetomidine Versus Midazolam in Critically Ill Ventilated Children
Lead Sponsor:
Douglas Fraser
Conditions:
Mechanically Ventilated, Critically Ill Children
Eligibility:
All Genders
1-17 years
Phase:
PHASE3
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 centr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04082767
Start Date
June 8 2021
End Date
September 1 2024
Last Update
December 11 2023
Active Locations (1)
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1
Children's Hospital - London Health Sciences Centre
London, Ontario, Canada, N6A 5W9