Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
100
Countries
1
Sites
1
Sedation in healthy children
Success rate of intranasal dexmedetomidine
Key facts
- Sponsor
- Universitair Ziekenhuis Antwerpen
- 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]
- Decision date (initial)
- 2025-11-07
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- University Hospital Antwerp
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
Success rate of intranasal dexmedetomidine
Secondary objectives 6
- Success rate after one dose of intranasal dexmedetomidine
- Success rate after an additional dose of 1 µg/kg of intranasal dexmedetomidine
- Success rate of intranasal dexmedetomidine per procedure
- Influencing factor for success rate
- Prevalence of side effects after one dose of intranasal dexmedetomidine
- Prevalence of side effects after an additional dose of dexmedetomidine
Conditions and MedDRA coding
Sedation in healthy children
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age 6 months - 12 years
- Weight < 30 kg
- Indication for non-invasive radiological procedure
- ASA I or II
Exclusion criteria 19
- Age < 6 months
- Age > 12 years
- Hypersensitivity to any of the substances of the product
- Drug allergy
- Grade 2 or 3 heart block (unless paced)
- Taking medicine with rate slowing action on AV-node? For example: digoxin, beta-adrenergic blockers, calcium channel blockers, monoamine oxidase inhibitor or other agents that predispose to bradycardia or hypotension
- Uncontrolled chronic hypertension/hypotension
- Congenital cardiac problems
- Decreased cardiac output
- Acute cerebrovascular conditions
- ASA III or IV status
- Hepatic abnormalities
- Central nervous system dysfunction
- Spinal cord injuries
- Respiratory dysfunction
- Increased pulmonary artery pressure
- Renal dysfunction
- Septic shock
- Risk of difficult intubation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Success rate after one dose of intranasal dexmedetomidine
Secondary endpoints 7
- Success rate after an additional dose of intranasal dexmedetomidine (when adequate sedation is not reached after the first dose)
- Time to the onset of sedation after the first administration of intranasal dexmedetomidine (minutes)
- Duration of the sedation (minutes)
- Duration of the procedure (minutes)
- Waiting time until procedure (minutes)
- Total length of hospital stay (minutes)
- Prevalence of side effects
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion
PRD10126121 · Product
- Active substance
- Dexmedetomidine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRANASAL USE
- Max daily dose
- 200 µg microgram(s)
- Max total dose
- 200 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05CM18 — -
- Marketing authorisation
- PL 03551/0161
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Ziekenhuis Antwerpen
- Sponsor organisation
- Universitair Ziekenhuis Antwerpen
- Address
- Drie Eikenstraat 655
- City
- Edegem
- Postcode
- 2650
- Country
- Belgium
Scientific contact point
- Organisation
- Universitair Ziekenhuis Antwerpen
- Contact name
- Sophie Rutten
Public contact point
- Organisation
- Universitair Ziekenhuis Antwerpen
- Contact name
- Sophie Rutten
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT number 2025-522778-34-00 | 2.1. |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults Dutch | 2.0. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults English | 2.0. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF children 4-6 yr Dutch | 2.0. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF children 6-12 yr Dutch | 2.0. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC dexmedetomidine | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Dutch EU CT number 2025-522778-34-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis English EU CT number 2025-522778-34-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis French EU CT number 2025-522778-34-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis German EU CT number 2025-522778-34-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-19 | Belgium | Acceptable with conditions 2025-11-07
|
2025-11-07 |