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Study of flumazenil for preventing emergence delirium in children after ear, nose and throat surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines pediatric emergence delirium, which is a condition where children become confused, agitated, or distressed when waking up from anesthesia. This condition can occur in children after they have undergone ear, nose, and throat surgery. The study will use flumazenil, a medication that reverses the effects of another drug called midazolam, which is commonly used to help patients relax before and during surgery. The comparison treatment in this study is sodium chloride, which is a salt water solution. Both medications will be given by injection.

The purpose of this study is to find out whether using flumazenil affects how often children experience confusion and agitation when waking up from anesthesia after ear, nose, and throat procedures. The study will involve children between three and seven years old who are having ear, nose, and throat surgery. During the study, children will receive either flumazenil or the salt water solution to reverse the relaxing effects of midazolam that was given before their surgery.

After the surgery is completed and the child wakes up, the medical team will observe and record whether the child shows signs of confusion or agitation in the recovery room. The observations will continue until the child is ready to leave the recovery room. The study will compare how often these symptoms occur in children who received flumazenil versus those who received the salt water solution.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial participation in the study

    Your child will be included in the study if they meet the required criteria: age between 3 and 7 years, generally healthy or with mild health conditions (classified as ASA status I and II, which means your child is either completely healthy or has mild health issues that do not limit daily activities), and scheduled for ear, nose, or throat surgery.

    Your consent as the legal guardian is required, and sufficient German language skills are necessary for participation.

  2. Step 2

    Surgical procedure and medication administration

    Your child will undergo the planned ear, nose, or throat surgery under anesthesia.

    During the procedure, your child may receive Midazolam (also known as Dormicum), a medication used for sedation.

    After the surgery, your child may receive Flumazenil, a medication administered by injection that reverses the sedative effects of Midazolam. The study examines whether this medication influences the occurrence of confusion or agitation after waking up from anesthesia.

    Alternatively, your child may receive sodium chloride (a salt solution) by injection, which serves as a comparison in the study.

  3. Step 3

    Observation in the recovery room

    After the surgery, your child will be monitored in the recovery room until discharge from this area.

    The medical staff will observe your child for signs of emergence delirium, which is a temporary state of confusion, agitation, or disorientation that can occur in children after waking up from anesthesia.

    A specific scoring system will be used to assess whether your child experiences this condition. A score of 10 points or higher indicates the presence of emergence delirium.

  4. Step 4

    Discharge from the recovery room

    Once your child has sufficiently recovered and the observation period is complete, they will be discharged from the recovery room.

    The study participation concludes at this point.

Who can join the trial?

5 criteria

  • Your child must be between 3 and 7 years old
  • Your child must have an ASA status of I or II, which means your child is either healthy or has mild health problems that are well controlled
  • Your child must be scheduled for ENT surgery, which is an operation on the ear, nose, or throat, no matter what specific procedure is being done
  • You, as the legal guardian, must give your permission for your child to take part in this study
  • Your child must be able to speak and understand German well enough to communicate during the study

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified for this clinical trial in the provided information.
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Investigated drugs

  • Midazolam

    is a sedative medication that helps patients relax and feel calm before and during medical procedures. In this study, it is being used to sedate children during ear, nose, and throat surgery.

  • Flumazenil

    is a medication that reverses the effects of sedatives like Midazolam. It works by blocking the sedative effects and helping patients wake up more quickly after surgery. In this study, researchers are testing whether Flumazenil can help reduce confusion and agitation that some children experience when waking up after surgery.

What is already known about the treatment

Flumazenil – Flumazenil is a medication given through injection into a vein that works by blocking the effects of certain sedative drugs, specifically those in the benzodiazepine family like Midazolam. It acts at the molecular level by attaching to special receptors in the brain called GABA receptors, where it reverses the calming and sleep-inducing effects of benzodiazepines without activating these receptors itself. This medication belongs to a class of drugs known as benzodiazepine antagonists and is currently used in medical practice to reverse excessive sedation or to help patients wake up more quickly after procedures requiring sedation. In this clinical trial, researchers are studying whether Flumazenil can help reduce confusion and agitation that sometimes occurs in children waking up from anesthesia after ear, nose, and throat surgeries.

Investigated diseases

Pediatric Emergence Delirium – Pediatric emergence delirium is a temporary mental disturbance that occurs in children during the recovery period after general anesthesia. Children experiencing this condition may appear confused, agitated, or disoriented as they wake up from anesthesia. They may exhibit restless behavior, crying, thrashing movements, or fail to make eye contact with caregivers. The condition typically develops in the early recovery phase, shortly after the child regains consciousness following surgery. It is a self-limiting state that usually resolves on its own within a short period. The condition is particularly common in young children who have undergone certain types of surgical procedures.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase ITrial ID2025-523543-36-00Protocol codeFLUMA-StudyEstimated enrolment1 patientSponsorRheinische Friedrich-Wilhelms-Universitaet Bonn

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