Impact on delirium of the use of DEXmedetomidine as first-line sedation in PEDIAtric intensive care: the PEDIADEX randomized controlled trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Universitaire De Tours

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Decision date (initial)

2025-10-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To assess if continuous intravenous infusion of dexmedetomidine is effective to reduce the prevalence of delirium in critically ill children, needing mechanical ventilation for more than 12 hours.

Secondary objectives 8

1. A reducing of the cumulative number of days with a CAPD score higher than 9 (definition of delirium)
2. Consequences of delirium and differential diagnosis: electroencephalogram, brain imaging, need for antipsychotic drug,
3. An appropriate sedation score according to the COMFORTB during invasive ventilation with less unplanned extubation
4. An inferior mechanical ventilation time
5. An inferior intensive care unit length of stay
6. An inferior hospital length of stay out of the intensive care unit
7. An inferior in-hospital mortality
8. An inferior prevalence of iatrogenic withdrawal syndrome

Conditions and MedDRA coding

Impact on delirium of the use of DEXmedetomidine as first-line sedation in PEDIAtric intensive care:

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Children between 1 month to 17 years and 6 months
2. Participants covered by or entitled to French social security
3. 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)
4. Ability for participant to comply with the requirements of the study
5. Receiving sedation by benzodiazepines for less than 6 hours at the time of inclusion

Exclusion criteria 15

1. Patients under guardianship, curatorship or legal protection
2. Study interventions contraindications
3. Pregnant or breastfeeding woman (positive pregnancy test for women of childbearing age)
4. High-grade heart conduction disorder (Second or third-degree atrioventricular block)
5. Status epilepticus
6. Intracranial hypertension
7. Sedation for more than 6 hours by benzodiazepines at the time of inclusion
8. Need for paralytic medication (neuromuscular blocker) at admission to PICU
9. Following cardiac surgery
10. Palliative care on admission
11. Significant bradycardia (cf table)
12. Severe hepatic dysfunction (CHILD score C or worse) due to the hepatic metabolism of dexmedetomidine
13. Patient already enrolled in the study previously
14. Expected duration of invasive mechanical ventilation inferior to 12 hours
15. Hospitalized in a pediatric intensive care unit without computerized prescription software

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of children with at least one episode of delirium during the pediatric intensive care stay, measured with CAPD scale. Delirium will be defined as CAPD higher or equal to 9.

Secondary endpoints 19

1. The percentage of sedation scores in the target sedation range evaluated with COMFORT B scale every 4 hours, in each group
2. Percentage of under-sedation, and adverse events (such as unplanned extubation with reintubation, accidental removal of a central line)
3. Percentage of over-sedation
4. The daily cumulative weight-adjusted dose of IV sedative agents (benzodiazepine, ketamine, propofol) and opioids required in each group.
5. Number of days exposed to sedatives and opioids
6. The incidence of iatrogenic withdrawal syndrome
7. The number of days with CAPD score higher than or equal to 9
8. The severity of delirium defined by the need for antipsychotic drugs
9. Hypotension/ bradycardia, needing an intervention, unplanned extubation
10. accidental removal of a central line
11. The mechanical ventilation time in hours
12. Need for re-intubation post extubation
13. Percentage of brain imaging , electroencephalogramm
14. Intensive care unit length of stay, in days
15. Hospital length of stay out of the intensive care unit, in days
16. In-hospital mortality
17. The incidence of iatrogenic withdrawal syndrome
18. Difference in the costs of sedative, analgesics and opioids consumed during the paediatric intensive care stay and valued from the hospital perspective;
19. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Universitaire De Tours

Sponsor organisation

Centre Hospitalier Regional Universitaire De Tours

Address

2 Boulevard Tonnelle

City

Tours Cedex 9

Postcode

37044

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Universitaire De Tours

Contact name

Julie CHANTREUIL

Public contact point

Organisation

Centre Hospitalier Regional Universitaire De Tours

Contact name

Julie CHANTREUIL

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications