Study on the influence of FLUMAzenil regarding the incidence of pediatric emergence delirium (ED) in children undergoing ENT surgery – FLUMA Study

Status

Not yet recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523543-36-00

Acronym

FLUMA-Study

Enrollment

Registered

2026-01-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pediatric emergence delirium

Brief summary

The occurrence of postoperative delirium (pädED) until discharge from the recovery room. A score of ≥ 10 points is indicative of delirium.

Interventions

DRUGFlumazenil B. Braun 0

DRUG1 mg/ml Injektionslösung und Konzentrat zur Herstellung einer Infusionslösung

DRUGSODIUM CHLORIDE

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The occurrence of postoperative delirium (pädED) until discharge from the recovery room. A score of ≥ 10 points is indicative of delirium.	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026