Overview
Sponsor-declared trial summary
pediatric emergence delirium
The FLUMA Study will examine the occurrence of pediatric emergence delirium in children following ENT surgery after antagonisation of the sedative effect of Midazolam (Dormicum®) by Flumazenil®.
Key facts
- Sponsor
- Rheinische Friedrich-Wilhelms-Universitaet Bonn
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 18 May 2026 → ongoing
- Decision date (initial)
- 2026-01-23
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Medical Faculty, University of Bonn (Funding instrument for clinical studies (FKS))
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Therapy
The FLUMA Study will examine the occurrence of pediatric emergence delirium in children following ENT surgery after antagonisation of the sedative effect of Midazolam (Dormicum®) by Flumazenil®.
Conditions and MedDRA coding
pediatric emergence delirium
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Children aged 3-7
- ASA status I and II
- ENT anesthesia, regardless of the procedure
- Consent of the legal guardian
- Sufficient language skills in German
Exclusion criteria 3
- ASA status III or IV
- Lack of consent from the legal guardian
- Contraindications for the use of benzodiazepines or flumazenil
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The occurrence of postoperative delirium (pädED) until discharge from the recovery room. A score of ≥ 10 points is indicative of delirium.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Flumazenil B. Braun 0,1 mg/ml Injektionslösung und Konzentrat zur Herstellung einer Infusionslösung
PRD11884126 · Product
- Active substance
- Flumazenil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INJECTION
- Max daily dose
- 0.05 mg/kg milligram(s)/kilogram
- Max total dose
- 0.05 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AB25 — FLUMAZENIL
- Marketing authorisation
- 64945.00.00
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- INFUSION
- Route of administration
- INJECTION
- Max daily dose
- 0.02 millilitre(s)/kilogram
- Max total dose
- 0.02 millilitre(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rheinische Friedrich-Wilhelms-Universitaet Bonn
- Sponsor organisation
- Rheinische Friedrich-Wilhelms-Universitaet Bonn
- Address
- Venusberg-Campus 1, Venusberg Venusberg
- City
- Bonn
- Postcode
- 53127
- Country
- Germany
Scientific contact point
- Organisation
- Rheinische Friedrich-Wilhelms-Universitaet Bonn
- Contact name
- Univ.-Prof. Dr. med. Dr. habil Ehrenfried Schindler
Public contact point
- Organisation
- Rheinische Friedrich-Wilhelms-Universitaet Bonn
- Contact name
- Univ.-Prof. Dr. med. Dr. habil Ehrenfried Schindler
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 1 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2026-05-18 | 2026-05-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 21 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-523543-36-00 modif | 2.1 |
| Protocol (for publication) | D1_Protocol 2025-523543-36-00 clean | 1.2 |
| Protocol (for publication) | D1_Protocol 2025-523543-36-00 modif | 1.2 |
| Protocol (for publication) | D1_Protocol 2025-523543-36-00 track changes | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Erlauterungen zum Probandenjahresvertrag | 1 |
| Subject information and informed consent form (for publication) | flacc | 1 |
| Subject information and informed consent form (for publication) | FPSR AU3 0deu DE | 1 |
| Subject information and informed consent form (for publication) | Induction_Compliance_Checklist_ICC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1.5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults clean | 1.5 |
| Subject information and informed consent form (for publication) | mypas-crf | 1 |
| Subject information and informed consent form (for publication) | PAED-Score | 1 |
| Subject information and informed consent form (for publication) | SDQ_German_pt2-4single | 1 |
| Subject information and informed consent form (for publication) | SDQ_German_pt4-17single | 1 |
| Subject information and informed consent form (for publication) | STAI X1 | 1 |
| Subject information and informed consent form (for publication) | STAI X2 | 1 |
| Subject information and informed consent form (for publication) | Versicherungsbestatigung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC flumazenil | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC isotone-kochsalz-loesung-0-9-braun | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-30 | Germany | Acceptable with conditions 2025-12-19
|
2026-01-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-23 | Germany | Acceptable 2026-02-11
|
2026-02-11 |