Frontlight ResearchEarly access
Taking peoplePhase 4
Study on the influence of FLUMAzenil regarding the incidence of pediatric emergence delirium (ED) in children undergoing ENT surgery – FLUMA Study
Key facts
- Who runs it
- Rheinische Friedrich-Wilhelms-Universitaet Bonn
- Where
- Germany1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 1 person, planned
- Started
- 18 May 2026
- Expected to end
- 31 Dec 2029
- Type of study
- Interventional
- Record updated
- 11 February 2026
Who can take part
- Age
- Up to 17 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- ASA status III or IV
- Lack of consent from the legal guardian
- Contraindications for the use of benzodiazepines or flumazenil
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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®.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Record updated
- 11 February 2026