← Back to Search

Alpha-2 Agonist

Dexmedetomidine for Critically Ill Children

Phase 3
Recruiting
Led By Douglas D Fraser, MD., PhD
Research Sponsored by Douglas Fraser
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patient is intubated and is expected to remain intubated for at least the next 48 hours
Age is 1 month to 18 years inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days post-randomization
Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of two sedatives in pediatric patients.

Who is the study for?
This trial is for critically ill children aged 1 month to 18 years who are intubated, expected to remain so for at least 48 hours, and have been on mechanical ventilation for less than 72 hours. They must already be on opioid infusions as per PCCU guidelines and need extra sedation.Check my eligibility
What is being tested?
The study compares the safety and effectiveness of two sedatives: Dexmedetomidine (Precedex) versus Midazolam in ventilated children. It's a randomized clinical trial focusing on sedation levels, delirium instances, EEG analysis, and patient outcomes.See study design
What are the potential side effects?
Possible side effects include increased agitation and delirium with Midazolam which may lead to longer hospital stays. Dexmedetomidine might offer fewer negative effects but specific side effects are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on a breathing machine and will be for at least 2 more days.
Select...
I am between 1 month and 18 years old.
Select...
I am currently on an opioid infusion for pain and need more sedation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Target Sedation Range
Secondary outcome measures
Adverse event (AE) occurrence
Delirium
Duration of mechanical ventilation
+7 more
Other outcome measures
Economic Analysis

Trial Design

2Treatment groups
Active Control
Group I: DexmedetomidineActive Control1 Intervention
Group II: MidazolamActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Douglas FraserLead Sponsor
Douglas D Fraser, MD., PhDPrincipal InvestigatorLawson Health Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I be able to join in this research project?

"Up to 120 paediatric patients that have been critically ill for less than 72 hours and are expected to remain intubated for the next 48 hours may be enrolled. Thesepatients must also meet the following age, ventilation, and opioid infusion requirements."

Answered by AI

If so, what have other researchers found when studying Dexmedetomidine?

"As of today, there are a total of 174 clinical trials researching Dexmedetomidine. Out of those, 32 are considered Phase 3 studies. Although the majority of research is based in Porto Alegre and California, 903 different locations across the world are running these medical trials."

Answered by AI

Does this research involve individuals who are senior citizens?

"This trial is looking for individuals that are at least 1 month old, and no older than 17 years."

Answered by AI

For what reasons is Dexmedetomidine commonly prescribed?

"Dexmedetomidine is a medication used to sedate patients and relieve anxiety. It can also be employed as part of amnesia induction therapy or to treat convulsive status epilepticus."

Answered by AI

Is there a risk of negative side effects from using Dexmedetomidine?

"There is some clinical data supporting dexmedetomidine's efficacy, as well as multiple rounds of safety testing. We've given it a score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Sedation Efficacy of Dexmedetomidine Versus Midazolam in Critically Ill Ventilated Children
Douglas Fraser 2021. "Sedation Efficacy of Dexmedetomidine Versus Midazolam in Critically Ill Ventilated Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04082767.
~9 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top