A Phase 3 interventional study of Dexmedetomidine and Midazolam in Delirium in the Intensive Care Unit, sponsored by University Hospital, Tours. Not yet recruiting at 7 sites in France. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by University Hospital, Tours · Phase 3, Interventional, and Prevention
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 :
Participants will be sedated with midazolam or dexmedetomidine, according to randomization arm, and the rest of sedation is determined by the study protocol.
- 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.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's planned enrollment of 266 is above the median of 112 across 550 interventional studies indexed under Delirium.
Browse Delirium studies →University Hospital, Tours is the lead sponsor of 307 studies on the registry; 79 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Dexmedetomidine
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
Drug: Midazolam
Participants in intervention arm will receive dexmedetomidine as primary sedative. We will assess if there is less delirium in the intervention arm
participant will receive midazolam as the comparator group
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.
Time frame: From enrollment to the end of ICU stay, up to 90 days
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
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of ICU stay, up to 90 days
Mechanical ventilation
Investigators will report the mechanical ventilation time in hours
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from enrollement to the end of hospital stay, up to 90 days
Mortality
Investigators will assess: hospital mortality
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: from enrollment, to the end of sedation, up to 90 days
Start is estimated for Nov 2026; primary completion for Apr 2029, 29 months later.
Of 27 phase 3 interventional studies under Delirium, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 59. This study's planned 29 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Apr 2026 → Nov 2026, on Sep 28, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine