Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care (PEDIADEX)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Delirium in the Intensive Care Unit
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Midazolam

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 Type: Interventional
• Enrollment (Estimated): 266
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Julie Chantreuil, Dr; Phone Number: +33247478214; Email: j.chantreuil@chu-tours.fr
• Study Contact Backup: Name: Lea Savary, Dr; Phone Number: +33147474756; Email: l.savary@chu-tours.fr

Study Locations

• France
  • Angers, France, 49933
    • CHU d'Angers
    • Contact: Amandine Prenant, Dr; Phone Number: +33241355088; Email: amandine.prenant@chu-angers.fr
  • Caen, France, 14033
    • CHU de Caen
    • Contact: David Brossier, Dr; Phone Number: +33231063106; Email: brossier-d@chu-caen.fr
  • Lille, France, 59120
    • CHU de LILLE
    • Contact: Stephane Leteurtre, Pr; Phone Number: +33320445982; Email: stephane.LETEURTRE@chu-lille.fr
  • Marseille, France, 13385
    • CHU de Marseille
    • Contact: Fabrice Michel, Pr; Phone Number: +33413429525; Email: fabrice.michel@ap-hm.fr
  • Nantes, France, 44093
    • CHU de Nantes
    • Contact: Bénédicte Gaillard-Leroux, Dr; Phone Number: +33240083483; Email: benedicte.gaillardleroux@chu-nantes.fr
  • Strasbourg, France, 67200
    • CHU de Strasbourg
    • Contact: Charlie Demelo, Dr; Phone Number: +33388127317; Email: charlie.demelo@chru-strasbourg.fr
  • Tours, France, 37000
    • Chu De Tours
    • Contact: Julie Chantreuil, Dr; Phone Number: +33247478214; Email: j.chantreuil@chu-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dexmedetomidine; 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; Participants in intervention arm will receive dexmedetomidine as primary sedative. We will assess if there is less delirium in the intervention arm
Active Comparator: midazolam; 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; participant will receive midazolam as the comparator group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of ICU stay, up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	From enrollment to the end of ICU stay, up to 90 days
Mechanical ventilation	Investigators will report the mechanical ventilation time in hours	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.	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	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	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	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	from enrollement to the end of hospital stay, up to 90 days
Mortality	Investigators will assess: hospital mortality	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)	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.	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	from enrollment, to the end of sedation, up to 90 days

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Collaborators: University Hospital, Strasbourg, France; University Hospital, Angers; University Hospital, Caen; University Hospital, Lille; Nantes University Hospital; University Hospital, Marseille

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): April 15, 2029
• Study Completion (Estimated): August 15, 2029

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: intensive care unit; delirium; pediatric; midazolam; dexmedetomidine
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Delirium; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Imidazoles; Benzazepines; Benzodiazepines; Midazolam; Dexmedetomidine
• Other Study ID Numbers: PEDIADEX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No