Clinical trial • Not applicable • Other
Flumazenil for Pediatric emergence delirium
Not applicable trial of Flumazenil for Pediatric emergence delirium.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Pediatric emergence delirium
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 30-10-2025
- First CTIS Authorization Date
- 23-01-2026
Trial design
Flumazenil B. Braun 0,1 mg/ml (active substance: flumazenil) - test product; dose unit mg/kg, max daily/total dose 0.05 mg/kg; route: injection. Comparator/placebo: SODIUM CHLORIDE (isotonic saline solution) - placebo; dose unit millilitre(s)/kilogram, max total dose 0.02 millilitre(s)/kilogram; route: injection.-controlled Not applicable trial across 1 site in Germany.
- Comparator
- Flumazenil B. Braun 0,1 mg/ml (active substance: flumazenil) - test product; dose unit mg/kg, max daily/total dose 0.05 mg/kg; route: injection. Comparator/placebo: SODIUM CHLORIDE (isotonic saline solution) - placebo; dose unit millilitre(s)/kilogram, max total dose 0.02 millilitre(s)/kilogram; route: injection.
Eligibility
Recruits 1 paediatric patients.
- Vulnerable Population
- Children aged 3-7 considered a vulnerable population; consent must be provided by the legal guardian ("Consent of the legal guardian" required).
Inclusion criteria
- {"criterion_text":"- Children aged 3-7"}
- {"criterion_text":"- ASA status I and II"}
- {"criterion_text":"- ENT anesthesia, regardless of the procedure"}
- {"criterion_text":"- Consent of the legal guardian"}
- {"criterion_text":"- Sufficient language skills in German"}
Exclusion criteria
- {"criterion_text":"- ASA status III or IV"}
- {"criterion_text":"- Lack of consent from the legal guardian"}
- {"criterion_text":"- Contraindications for the use of benzodiazepines or flumazenil"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The occurrence of postoperative delirium (pädED) until discharge from the recovery room. A score of ≥ 10 points is indicative of delirium.","definition_or_measurement_approach":"Occurrence of postoperative delirium measured until discharge from the recovery room; a score of ≥ 10 points is indicative of delirium."}
Recruitment
- Recruitment Window Months
- 47
- Consent Approach
- Informed consent to be provided by the legal guardian. Subject information and informed consent form documents are available (e.g. "L1_SIS and ICF adults"); required language skills: German ('Sufficient language skills in German'). No mention of child assent procedures in available documents.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 1
Germany
- Earliest CTIS Part Ii Submission Date
- 20-01-2026
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 3
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Rheinische Friedrich-Wilhelms-Universitaet Bonn
- Department Name
- Department ofAnesthesiology and Operative Intensive Care Medicine
- Principal Investigator Name
- Univ.-Prof. Dr. med. Dr. habil Ehrenfried Schindler
- Principal Investigator Email
- Ehrenfried.Schindler@ukbonn.de
- Contact Person Name
- Ehrenfried Schindler
- Contact Person Email
- Ehrenfried.Schindler@ukbonn.de
- Number Of Participants
- 1
Sponsor
Primary sponsor
- Full Name
- Rheinische Friedrich-Wilhelms-Universitaet Bonn
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Flumazenil B. Braun 0,1 mg/ml Injektionslösung und Konzentrat zur Herstellung einer Infusionslösung
- Active Substance
- Flumazenil
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- Authorised (PRD11884126; authorisation country: DE; MRPs: NL/H/0915/001)
- Maximum Dose
- 0.05 mg/kg
- Investigational Product Name
- SODIUM CHLORIDE
- Active Substance
- Sodium chloride
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- Authorised (marketing product reference SUB12581MIG)
- Maximum Dose
- 0.02 millilitre(s)/kilogram
Related trials
Other published trials that may interest you.