Delirium in the Intensive Care UnitPhase 3PEDIADEXNCT07542990
Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care
A Phase 3 study testing Dexmedetomidine and Midazolam in people with Delirium in the Intensive Care Unit, run by University Hospital, Tours at 7 sites in France.
Trial summary
The goal of this clinical trial is to learn if dexmedetomidine can reduce delirium in critically ill children, needing mechanical ventilation for more than 12 hours. The main question it aims to answer is : Does dexmedetomidine reduce the proportion of children presenting at least one episode of delirium during their… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Delirium in the Intensive Care Unit
- What is being tested?
- Dexmedetomidine and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 7 sitesFrance
- Study dates
- 15 Nov 2026to 15 Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children between 1month to 17 years and 6 months
- Sedation and analgesia for mechanical ventilation for more than 12 hours
- Participants covered by or entitled to French social security
- Informed consent, dated and signed, from the participant's legal representative(s). (The emergency inclusion procedure will be used if the legal representative(s) cannot be contacted. When the legal representative(s) and the patient are available and/or able to consent, informed consent from the participant's legal representative(s)
- Ability for participant to comply with the requirements of the study
- Receiving sedation by benzodiazepines for less than 6 hours at the time of inclusion
Who cannot join
- Patients under guardianship, curatorship or legal protection
- Pregnant or breastfeeding woman (positive pregnancy test for women of childbearing age)
- High-grade heart conduction disorder (Second or third-degree atrioventricular block)
- Status epilepticus
- Intracranial hypertension
- Sedation for more than 6 hours by benzodiazepines at the time of inclusion
Show all 14Show fewer
- Need for paralytic medication (neuromuscular blocker) at admission to PICU
- Following cardiac surgery
- Palliative care on admission
- Significant bradycardia
- Severe hepatic dysfunction (CHILD score C or worse) due to the hepatic metabolism of dexmedetomidine
- Patient already enrolled in the study previously
- Expected duration of invasive mechanical ventilation inferior to 12 hours
- Hospitalized in a pediatric intensive care unit without computerized prescription software
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites
CHU d'Angers
Angers, 49933
Amandine Prenant, Dr, +33241355088, amandine.prenant@chu-angers.fr
CHU de Caen
Caen, 14033
David Brossier, Dr, +33231063106, brossier-d@chu-caen.fr
CHU de Lille
Lille, 59120
Stephane Leteurtre, Pr, +33320445982, stephane.LETEURTRE@chu-lille.fr
CHU de Marseille
Marseille, 13385
Fabrice Michel, Pr, +33413429525, fabrice.michel@ap-hm.fr
CHU de Nantes
Nantes, 44093
Bénédicte Gaillard-Leroux, Dr, +33240083483, benedicte.gaillardleroux@chu-nantes.fr
CHU de Strasbourg
Strasbourg, 67200
Charlie Demelo, Dr, +33388127317, charlie.demelo@chru-strasbourg.fr
CHU de Tours
Tours, 37000
Julie Chantreuil, Dr, +33247478214, j.chantreuil@chu-tours.fr
About this study
Official title: Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care: the PEDIADEX Randomized Controlled Trial
The goal of this clinical trial is to learn if dexmedetomidine can reduce delirium in critically ill children, needing mechanical ventilation for more than 12 hours. The main question it aims to answer is :
- Does dexmedetomidine reduce the proportion of children presenting at least one episode of delirium during their intensive care unit (ICU) stay ? Researchers will compare dexmetomidine to midazolam, to see if the use of dexmedetomidine reduces the prevalence of delirium.
Participants will be sedated with midazolam or dexmedetomidine, according to randomization arm, and the rest of sedation is determined by the study protocol.
Read the detailed description
- In the experimental group, participants will receive dexmedetomidine as primary sedative, with opioids for analgesia in order to reach sedation within the target range evaluated with the COMFORT B scale every 4 hours.
The initial dose of dexmedetomidine continuous infusion is 0.7 µg/kg/h with increases of 0.2 µg/kg/h if needed associated to an opioid continuous infusion (sufentanil at 0.2 µg/kg/h or morphine at 40 µg/kg/h). A protocol to adjust level of sedation according to the COMFORT B scale will be followed with maximal doses of 1.4 µg/kg/h for dexmedetomidine, 1.5 µg/kg/h for sufentanil and 300 µg/kg/h for morphine. Other drugs like ketamine up to 2 mg/kg/h, propofol, other opioids, midazolam at bolus or small doses (beginning between 20 µg/kg/h and 0.5 mg/h according to age/weight) are possible and will be reported.
- In the control group, participants with invasive ventilation will receive midazolam as first line therapy with opioids in order to reach sedation within the target sedation range evaluated with the COMFORT B scale every 4 hours.
The initial dose of midazolam is 40 µg/kg/h for children <2 years, 60 µg/kg/h for children after 2 years, and 1 mg/h for children >40kg associated with sufentanil at 0.2 µg/kg/h or intravenous morphine at 40 µg/kg/h. A protocol to adjust level of sedation according to the COMFORT B scale will be followed with maximal doses of 200 µg/kg/h and 10 mg/h if >40kg for midazolam and 1.5 µg/kg/h for sufentanil or 300 mcg/kg/h for morphine. Other drugs like ketamine up to 2 mg/kg/h, propofol, other opioids, are possible and noted. In case of failure, addition of dexmedetomidine will be possible only if midazolam is used at maximal doses.
- Conditions
- Delirium in the Intensive Care Unit
- Being tested
- Dexmedetomidine, Midazolam
- Keywords
- delirium, pediatric, dexmedetomidine, midazolam, intensive care unit
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Participants in intervention arm will receive dexmedetomidine as primary sedative. We will assess if there is less delirium in the intervention arm
MidazolamDrug
participant will receive midazolam as the comparator group
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | Participants with invasive ventilation will receive dexmedetomidine as primary sedative, with opioids for analgesia in order to reach sedation within the target range evaluated with the COMFORT B scale every 4 hours. Receives: Drug: Dexmedetomidine |
| midazolam | Active comparator | In the control group, participants will receive midazolam as first line therapy with opioids in order to reach sedation within the target sedation range evaluated with the COMFORT B scale every 4 hours Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children with at least one episode of delirium during the ICU stay.
Surveillance of delirium is part of the routine neurological monitoring in pediatric ICU. CAPD score is an 8-items scale. A score of 9 points or higher indicates the presence of delirium. We will evaluate the proportion of children with at least one CAPD score higher than 9.
Measured: From enrollment to the end of ICU stay, up to 90 days
Secondary outcomes (13)
Sedation efficacy
Investigators will assess:
- The percentage of sedation scores in the target sedation range evaluated with COMFORT B scale every 4 hours, in each group
- Percentage of under-sedation, and adverse events (such as unplanned extubation with reintubation, accidental removal of a central line)
- Percentage of over-sedation
Measured: From enrollment to the end of sedation, up to 90 days
Duration of delirium
Investigators will assess the number of days with CAPD score higher than or equal to 9
Measured: from enrollment to the end of ICU stay, up to 90 days
Adverse events and serious adverse events
Investigators will record:
- Hypotension and/or bradycardia needing an intervention, unplanned extubation
- accidental removal of a central line
Measured: From enrollment to the end of ICU stay, up to 90 days
Mechanical ventilation
Investigators will report the mechanical ventilation time in hours
Measured: From enrollment to extubation, for an average of 7 days
Health economic end points
Investigators will assess the cumulative doses of IV sedative and analgesic drugs so we can compare:
- Difference in the costs of sedative, analgesics and opioids consumed during the paediatric intensive care stay and valued from the hospital perspective;
- Difference in the cost of inpatient stays and the cost of stays in intensive care units valued from the healthcare system perspective, over a three month time horizon.
Measured: From enrollment to the end of hospital stay, up to 90 days
Severity of delirium
Investigators will assess the severity of delirium defined by the need for antipsychotic drugs
Measured: from enrollement to the end of hospital stay, up to 90 days
Need for re-intubation
Investigators will report the need for re-intubation post extubation
Measured: from enrollment, to the end of hospital stay, up to 90 days
Need for neurological investigations
Investigators will report the percentage of brain imaging and electroencephalogramm
Measured: from enrollement to the end of hospital stay, up to 90 days
Length of stay
Investigators will report
- Intensive care unit length of stay, in days
- Hospital length of stay out of the intensive care unit, in days
Measured: from enrollement to the end of hospital stay, up to 90 days
Mortality
Investigators will assess: hospital mortality
Measured: from enrollement, to the end of follow-up, up to 90 days
Withdrawal
Investigators will assess the incidence of iatrogenic withdrawal syndrome, measured with WAT-score (defined by WAT > 4)
Measured: from enrollement to the end of ICU stay, up to 90 days
Associated sedation
Investigators will assess the daily cumulative weight-adjusted dose of IV sedative agents (benzodiazepine, ketamine, propofol) and opioids required in each group.
Measured: from enrollement, to the end of sedation, up to 90 days
Duration of sedation
Invesitgators will assess the number of days exposed to sedatives and opioids
Measured: from enrollment, to the end of sedation, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Apr 2029 (estimated)
- Study completion15 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in the Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Angers, University Hospital, Lille, Nantes University Hospital, University Hospital, Strasbourg, France, University Hospital, Marseille, University Hospital, Caen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542990
- Sponsor's protocol ID
- PEDIADEX
- Acronym
- PEDIADEX
- Status last verified
- Sep 2026
- First submitted
- 5 Mar 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care: the PEDIADEX Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07542990
- Acronym / sponsor ID
- PEDIADEX / PEDIADEX
- Conditions
- Delirium in the Intensive Care Unit
- Keywords
- delirium, pediatric, dexmedetomidine, midazolam, intensive care unit
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- University Hospital, Angers, University Hospital, Lille, Nantes University Hospital, University Hospital, Strasbourg, France, University Hospital, Marseille, University Hospital, Caen
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Apr 2029 (estimated)
- Study completion
- 15 Aug 2029 (estimated)
- First posted
- 21 Apr 2026 (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.
The goal of this clinical trial is to learn if dexmedetomidine can reduce delirium in critically ill children, needing mechanical ventilation for more than 12 hours. The main question it aims to answer is :
- Does dexmedetomidine reduce the proportion of children presenting at least one episode of delirium during their intensive care unit (ICU) stay ? Researchers will compare dexmetomidine to midazolam, to see if the use of dexmedetomidine reduces the prevalence of delirium.
Participants will be sedated with midazolam or dexmedetomidine, according to randomization arm, and the rest of sedation is determined by the study protocol.
Detailed description
- In the experimental group, participants will receive dexmedetomidine as primary sedative, with opioids for analgesia in order to reach sedation within the target range evaluated with the COMFORT B scale every 4 hours.
The initial dose of dexmedetomidine continuous infusion is 0.7 µg/kg/h with increases of 0.2 µg/kg/h if needed associated to an opioid continuous infusion (sufentanil at 0.2 µg/kg/h or morphine at 40 µg/kg/h). A protocol to adjust level of sedation according to the COMFORT B scale will be followed with maximal doses of 1.4 µg/kg/h for dexmedetomidine, 1.5 µg/kg/h for sufentanil and 300 µg/kg/h for morphine. Other drugs like ketamine up to 2 mg/kg/h, propofol, other opioids, midazolam at bolus or small doses (beginning between 20 µg/kg/h and 0.5 mg/h according to age/weight) are possible and will be reported.
- In the control group, participants with invasive ventilation will receive midazolam as first line therapy with opioids in order to reach sedation within the target sedation range evaluated with the COMFORT B scale every 4 hours.
The initial dose of midazolam is 40 µg/kg/h for children <2 years, 60 µg/kg/h for children after 2 years, and 1 mg/h for children >40kg associated with sufentanil at 0.2 µg/kg/h or intravenous morphine at 40 µg/kg/h. A protocol to adjust level of sedation according to the COMFORT B scale will be followed with maximal doses of 200 µg/kg/h and 10 mg/h if >40kg for midazolam and 1.5 µg/kg/h for sufentanil or 300 mcg/kg/h for morphine. Other drugs like ketamine up to 2 mg/kg/h, propofol, other opioids, are possible and noted. In case of failure, addition of dexmedetomidine will be possible only if midazolam is used at maximal doses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: DexmedetomidineParticipants with invasive ventilation will receive dexmedetomidine as primary sedative, with opioids for analgesia in order to reach sedation within the target range evaluated with the COMFORT B scale every 4 hours. |
| midazolam | Active comparator | Drug: MidazolamIn the control group, participants will receive midazolam as first line therapy with opioids in order to reach sedation within the target sedation range evaluated with the COMFORT B scale every 4 hours |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Children between 1month to 17 years and 6 months
- Sedation and analgesia for mechanical ventilation for more than 12 hours
- Participants covered by or entitled to French social security
- Informed consent, dated and signed, from the participant's legal representative(s). (The emergency inclusion procedure will be used if the legal representative(s) cannot be contacted. When the legal representative(s) and the patient are available and/or able to consent, informed consent from the participant's legal representative(s)
- Ability for participant to comply with the requirements of the study
Key exclusion criteria (14 listed)
- Patients under guardianship, curatorship or legal protection
- Pregnant or breastfeeding woman (positive pregnancy test for women of childbearing age)
- High-grade heart conduction disorder (Second or third-degree atrioventricular block)
- Status epilepticus
- Intracranial hypertension
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 |
|---|---|---|
| DexmedetomidineParticipants in intervention arm will receive dexmedetomidine as primary sedative. We will assess if there is less delirium in the intervention arm | Drug | dexmedetomidine |
| Midazolamparticipant will receive midazolam as the comparator group | Drug | midazolam |
Primary outcome
Proportion of children with at least one episode of delirium during the ICU stay.
Time frame: From enrollment to the end of ICU stay, up to 90 days
Surveillance of delirium is part of the routine neurological monitoring in pediatric ICU. CAPD score is an 8-items scale. A score of 9 points or higher indicates the presence of delirium. We will evaluate the proportion of children with at least one CAPD score higher than 9.
13 secondary outcomes
Sedation efficacy
Time frame: From enrollment to the end of sedation, up to 90 days
Duration of delirium
Time frame: from enrollment to the end of ICU stay, up to 90 days
Adverse events and serious adverse events
Time frame: From enrollment to the end of ICU stay, up to 90 days
Mechanical ventilation
Time frame: From enrollment to extubation, for an average of 7 days
Health economic end points
Time frame: From enrollment to the end of hospital stay, up to 90 days
Severity of delirium
Time frame: from enrollement to the end of hospital stay, up to 90 days
Need for re-intubation
Time frame: from enrollment, to the end of hospital stay, up to 90 days
Need for neurological investigations
Time frame: from enrollement to the end of hospital stay, up to 90 days
Length of stay
Time frame: from enrollement to the end of hospital stay, up to 90 days
Mortality
Time frame: from enrollement, to the end of follow-up, up to 90 days
Withdrawal
Time frame: from enrollement to the end of ICU stay, up to 90 days
Associated sedation
Time frame: from enrollement, to the end of sedation, up to 90 days
Duration of sedation
Time frame: from enrollment, to the end of sedation, up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
Related trials for Delirium in the Intensive Care Unit
Not yet recruiting
Family-partnered Delirium Prevention, Detection, and Management in the ICU
Delirium, Intensive Care Unit Delirium
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Not yet recruitingEarly Phase 1
reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit
Sleep, Circadian Dysregulation
Recruiting
Neurosteer Bedside Monitoring System
Delirium, Sedation
Not yet recruiting
Sleep Harmonization Via Bundled Team-Based Interventions in the ICU
Sleep Deprivation, Critical Illness
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and Midazolam in people with Delirium in the Intensive Care Unit, run by University Hospital, Tours at 7 sites in France.
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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Chantreuil, Dr (+33247478214, j.chantreuil@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children with at least one episode of delirium during the ICU stay. (time frame: From enrollment to the end of ICU stay, up to 90 days). 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 28 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.