Mechanically Ventilated, Critically Ill ChildrenPhase 3NCT04082767
Sedation Efficacy of Dexmedetomidine Versus Midazolam in Critically Ill Ventilated Children
A Phase 3 study testing Precedex and Midazolam in people with Mechanically Ventilated, Critically Ill Children, run by Douglas Fraser at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Mechanically Ventilated, Critically Ill Children
- What is being tested?
- Precedex and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jun 2021to Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Children's Hospital - London Health Sciences Centre
London, Ontario, N6A 5W9
Maysaa Assaf, BSc, 519-685-8500 ext. 77548, maysaa.assaf@lhsc.on.ca
Douglas D Fraser, MD/PhD
About this study
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.
- Being tested
- Precedex, Midazolam
- Keywords
- sedation, delirium, pediatric, critical care
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrecedexDrug
Also called dexmedetomidine
Precedex, dexmedetomidine hydrochloride, IV, 4mcg/mL, infusion duration determined by the clinical care team
MidazolamDrug
Midazolam, IV, 5mg/mL (for patients more than 10kg), 1mg/mL (for patients 2-10kg), infusion duration determined by the clinical care team
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Not described Receives: Drug: Precedex |
| Midazolam | Active comparator | Not described Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Sedation Range
The percentage of time spent within target sedation range, defined as COMFORT Behaviour Scale score of 11-22, which will be assessed at minimum every 4 hours.
Measured: Up to 14 days post-randomization
Secondary outcomes (13)
Delirium
Prevalence of delirium using the Cornell Assessment of Pediatric Delirium (CAPD) tool
Measured: Up to 14 days post-randomization
Delirium
Duration of delirium using the Cornell Assessment of Pediatric Delirium (CAPD) tool
Measured: Up to 14 days post-randomization
Delirium
Prevalence of delirium using raw and quantitative EEG
Measured: Up to 14 days post-randomization
Delirium
Duration of delirium using raw and quantitative EEG
Measured: Up to 14 days post-randomization
Duration of mechanical ventilation
Mechanical ventilation-free days through day 28 will be calculated as 28 minus the duration of mechanical ventilation. Participants who die, are still receiving mechanical ventilation, or are transferred from the PCCU still receiving mechanical ventilation by day 28 will be censored at 28 days and assigned zero mechanical ventilation-free days
Measured: Up to 28 days post-randomization
PCCU Length of Stay
Length of stay will be calculated from the time of PCCU admission to the time of PCCU discharge.
Measured: Up to 90 days post-randomization
Hospital Length of Stay
Hospital Length of Stay will be calculated from the time of PCCU admission to the time of physical hospital discharge.
Measured: Up to 90 days post-randomization
Adverse event (AE) occurrence
Documentation of treatment related adverse events including blood pressure/heart rate changes requiring decreasing or discontinuation of study drug or intervention, delirium requiring medical treatment, any unplanned extubation or line removals, aspirations, ulcerations, etc.determined to result from inadequate sedation
Measured: Randomization to 90 days post-randomization
Quantification of sleep stages and sleep quality assessment
Visual and automated scoring of sleep stages from EEG recordings Stage 1 sleep: scored when more than 15 seconds of the epoch is made up of theta activity (4to7 Hz) Stage 2 sleep: predominant theta activity (4 to 7 Hz) and occasional quick bursts of faster activity Stage 3/4 sleep: marked by high-amplitude slow waves Rapid eye movement (REM) sleep: characterized by low-amplitude, mixed-frequency theta waves, intermixed with some alpha waves (usually 1 to 2 Hz slower than wake).
Measured: Up to 14 days post-randomization
Pharmacokinetics - Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax)
Measured: Up to 14 days post-randomization
Pharmacokinetics - Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration-time curve (AUC)
Measured: Up to 14 days post-randomization
Use of open label boluses for sedation - number
Number of boluses (opioid and benzodiazepine) administered during the treatment period
Measured: Up to 14 days post-randomization
Use of open label boluses for sedation - total dose
Total dose of boluses (opioid and benzodiazepine) administered during the treatment period
Measured: Up to 14 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start8 Jun 2021
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanically Ventilated, Critically Ill ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Douglas Fraser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Douglas Fraser, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Douglas D Fraser, MD., PhD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082767
- Sponsor's protocol ID
- PEDSED01
- Status last verified
- Dec 2023
- First submitted
- 28 Aug 2019
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation Efficacy of Dexmedetomidine Versus Midazolam in Critically Ill Ventilated Children
- ClinicalTrials.gov ID
- NCT04082767
- Acronym / sponsor ID
- PEDSED01
- Keywords
- sedation, delirium, pediatric, critical care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Douglas FraserUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Precedex |
| Midazolam | Active comparator | Drug: Midazolam |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrecedexAlso: dexmedetomidinePrecedex, dexmedetomidine hydrochloride, IV, 4mcg/mL, infusion duration determined by the clinical care team | Drug | Dexmedetomidine |
| MidazolamMidazolam, IV, 5mg/mL (for patients more than 10kg), 1mg/mL (for patients 2-10kg), infusion duration determined by the clinical care team | Drug | Midazolam |
Primary outcome
Target Sedation Range
Time frame: Up to 14 days post-randomization
The percentage of time spent within target sedation range, defined as COMFORT Behaviour Scale score of 11-22, which will be assessed at minimum every 4 hours.
13 secondary outcomes
Delirium
Time frame: Up to 14 days post-randomization
Delirium
Time frame: Up to 14 days post-randomization
Delirium
Time frame: Up to 14 days post-randomization
Delirium
Time frame: Up to 14 days post-randomization
Duration of mechanical ventilation
Time frame: Up to 28 days post-randomization
PCCU Length of Stay
Time frame: Up to 90 days post-randomization
Hospital Length of Stay
Time frame: Up to 90 days post-randomization
Adverse event (AE) occurrence
Time frame: Randomization to 90 days post-randomization
Quantification of sleep stages and sleep quality assessment
Time frame: Up to 14 days post-randomization
Pharmacokinetics - Maximum plasma concentration (Cmax)
Time frame: Up to 14 days post-randomization
Pharmacokinetics - Area under the plasma concentration-time curve (AUC)
Time frame: Up to 14 days post-randomization
Use of open label boluses for sedation - number
Time frame: Up to 14 days post-randomization
Use of open label boluses for sedation - total dose
Time frame: Up to 14 days post-randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas D Fraser, MD., PhD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Precedex and Midazolam in people with Mechanically Ventilated, Critically Ill Children, run by Douglas Fraser at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maysaa Assaf, BSc (519-685-8500 ext. 77548, maysaa.assaf@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Sedation Range (time frame: Up to 14 days post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.