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Study on Reducing Anxiety in Children Undergoing Surgery: Comparing Midazolam and Tablet Distraction Techniques

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on understanding how to best manage perioperative anxiety in children who are undergoing day-care surgeries such as circumcision, dental care, or tonsillectomy/adenoidectomy. Perioperative anxiety refers to the stress and nervousness children may feel before, during, and after surgery. The study is comparing two methods to help reduce this anxiety: using a handheld multimedia device like an iPad, and a medication called midazolam, which is given as an oromucosal solution. Midazolam is a medication that helps to calm patients before surgery.

The purpose of the study is to see if using an iPad for distraction can be as effective or even better than midazolam in reducing anxiety in children. During the study, children will be randomly assigned to either use an iPad or receive midazolam before their surgery. The researchers will observe the children to see how anxious they are at different times, such as before the surgery starts and when they wake up afterward. The study aims to find out which method is safer and more effective in helping children feel less anxious during their surgical experience.

By participating in this study, researchers hope to improve the way anxiety is managed in young children undergoing surgery, making the experience less stressful for both the children and their parents. The study will continue until enough information is gathered to make a clear comparison between the two methods. The ultimate goal is to ensure that children have a more comfortable and less anxious experience when they need to undergo surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the child must be between 1 and 8 years old and scheduled for an elective procedure such as circumcision, dental care, or tonsillectomy/adenoidectomy in a day-care setting.

    Written informed consent is required from the legal parents or caretaker.

  2. Step 2

    Preparation for the procedure

    The child will be assessed for anxiety levels using the mYpas-score and a 5-point anxiety scale by parents.

    The child will receive either a handheld multimedia device (such as an iPad) for distraction or a dose of midazolam as premedication.

  3. Step 3

    Administration of midazolam

    If assigned to the midazolam group, the child will receive BUCCOLAM 2.5 mg oromucosal solution or Midazolam Rowa 2.5 mg oromucosal solution.

    The medication is administered orally as an oromucosal solution.

  4. Step 4

    Anesthesia induction

    The child will undergo anesthesia induction, and the level of anxiety will be monitored.

    The anesthesiologist will assess the induction process, noting any signs of stress or anxiety.

  5. Step 5

    Postoperative monitoring

    After the procedure, the child will be monitored for any respiratory complications such as laryngospasm or bronchospasm.

    Parental satisfaction with anxiety management will be evaluated using a satisfaction scale.

  6. Step 6

    Completion of the study

    The study aims to compare the effectiveness of multimedia distraction versus midazolam in managing anxiety.

    The primary endpoint is the reduction of anxiety levels during the perioperative period.

Who can join the trial?

4 criteria

  • Children must be **1 year or older** and **younger than 8 years**.
  • Children should be classified as **ASA 1 or 2**. This means they are either healthy or have mild health issues that do not limit their activities.
  • The child must be scheduled for an **elective** (planned) procedure such as circumcision, tonsillectomy, adenoidectomy, or dental care in a day-care setting.
  • **Written informed consent** must be provided by the child's legal parents or caretaker. This means the parents or caretaker agree to let the child participate in the study after understanding what it involves.

Who cannot join the trial?

8 criteria

  • Children who are not between the ages of one and eight years old.
  • Children who are not scheduled for a day-care surgery like circumcision, dental care, or tonsillectomy/adenoidectomy.
  • Children who have any medical condition that might interfere with the study.
  • Children who are not able to use or understand the multimedia device like a Tablet/IPAD.
  • Children who have allergies or reactions to midazolam, a medication used to help with anxiety.
  • Children who have a history of severe anxiety or other psychological conditions that require special treatment.
  • Children who are part of another clinical trial at the same time.
  • Children whose parents or guardians do not give permission for them to participate in the study.
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Investigated drugs

  • Midazolam

    is a medication used to help reduce anxiety before surgery. It is often given to children to help them feel more relaxed and calm before they receive anesthesia. In this trial, midazolam is being compared to other methods to see how well it works in reducing anxiety in young children undergoing surgery.

  • Handheld Multimedia (Tablet/IPAD)

    is being used as a distraction tool to help reduce anxiety in children before surgery. The idea is that by engaging with a tablet or IPAD, children might feel less anxious and more at ease before they receive anesthesia. This method is being tested to see if it can be as effective or even better than using medication like midazolam for anxiety control.

What is already known about the treatment

Midazolam – Midazolam is typically administered orally or intravenously and is used to reduce anxiety before medical procedures. It is well-established in medical literature as a sedative and anxiolytic, particularly in pediatric care. The main therapeutic indication for midazolam in this context is to alleviate perioperative anxiety in children undergoing elective surgeries such as circumcision, dental care, or tonsillectomy/adenoidectomy. At the molecular level, midazolam works by enhancing the effect of a neurotransmitter called gamma-aminobutyric acid (GABA) in the brain, which results in a calming effect. It is classified pharmacologically as a benzodiazepine.

Investigated diseases

Perioperative Anxiety in Children – This condition involves feelings of nervousness, fear, or unease that occur in children who are about to undergo surgery, such as circumcision, dental procedures, or tonsillectomy/adenoidectomy. It typically arises before the operation and can continue into the recovery period. The anxiety may manifest as crying, restlessness, or uncooperative behavior during the induction of anesthesia. The level of anxiety can vary, with some children appearing calm and others becoming hysterical. Managing this anxiety is crucial to ensure a smooth surgical experience and can involve various strategies to help the child feel more at ease.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-514642-37-00Estimated enrolment150 patientsSponsorUZ Brussel

sourced from the EU Clinical Trials Register and site verification

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