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

NCT07542990 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: PEDIADEX
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 7

Brief 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 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.

Conditions

Delirium in the Intensive Care Unit

Keywords

delirium; pediatric; dexmedetomidine; midazolam; intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Sedation efficacy

  From enrollment to the end of sedation, up to 90 days

• Duration of delirium

  from enrollment to the end of ICU stay, up to 90 days

• Adverse events and serious adverse events

  From enrollment to the end of ICU stay, up to 90 days

• Mechanical ventilation

  From enrollment to extubation, for an average of 7 days

• Health economic end points

  From enrollment to the end of hospital stay, up to 90 days

Study Arms (2)

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.

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

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

Participants in intervention arm will receive dexmedetomidine as primary sedative. We will assess if there is less delirium in the intervention arm

dexmedetomidine

Midazolam DRUG

participant will receive midazolam as the comparator group

midazolam

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Ability for participant to comply with the requirements of the study

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Tours: lead
• University Hospital, Angers: collaborator
• University Hospital, Lille: collaborator
• University Hospital, Strasbourg, France: collaborator
• University Hospital, Marseille: collaborator
• University Hospital, Caen: collaborator
• Nantes University Hospital: collaborator

Study Sites (7)

CHU d'Angers

Angers, 49933, France

Location

CHU de Caen

Caen, 14033, France

Location

CHU de Lille

Lille, 59120, France

Location

CHU de Marseille

Marseille, 13385, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU de Strasbourg

Strasbourg, 67200, France

Location

CHU de Tours

Tours, 37000, France

Location

MeSH Terms

Conditions

Delirium

Interventions

Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Julie Chantreuil, Dr

CONTACT

+33247478214; j.chantreuil@chu-tours.fr

Lea Savary, Dr

CONTACT

+33147474756; l.savary@chu-tours.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: April 21, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 15, 2029
• Study Completion (Estimated): August 15, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

FR (7)