Sedation Efficacy of Dexmedetomidine Versus Midazolam in Critically Ill Ventilated Children

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Children's Hospital - London Health Sciences Centre
RECRUITING
London
Contact Information
Primary
Maysaa Assaf, BSc
maysaa.assaf@lhsc.on.ca
519-685-8500
Time Frame
Start Date: 2021-06-08
Estimated Completion Date: 2024-09
Participants
Target number of participants: 120
Treatments
Active_comparator: Dexmedetomidine
Active_comparator: Midazolam
Related Therapeutic Areas
Sponsors
Leads: Douglas Fraser

This content was sourced from clinicaltrials.gov