RecruitingPHASE3INTERVENTIONAL

Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia

This research is investigating if certain calming medicines, called Midazolam or Dexmedetomidine, given before general anaesthesia, improve children's experiences with surgery. While these medicines are often used to reduce anxiety in younger children, there's not much evidence for those aged 7 to 18. Researchers want to see if these medicines truly help children feel less stressed before and after an operation, or if they might cause other issues like feeling too sleepy afterwards. Children taking part will be split into groups; some will receive one of the calming medicines, and others a dummy medicine (placebo). They will then complete questionnaires to share how they felt.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Hospital, Montpellier

Enrolment target

1,000

Start

18 Apr 2023

Estimated completion

18 Oct 2027

Anesthesia

What is this study about?

Going into hospital for an operation can be a bit scary for anyone, and especially for children. Some children might feel very anxious before surgery and even afterwards. Doctors often use calming medicines, called sedatives or anxiolytics, before surgery to help children relax and reduce this anxiety. These medicines are commonly used for very young children, and they seem to help them cope better.

However, we don't really know if these same medicines are as helpful for older children, specifically those aged 7 to 18. While they might reduce anxiety, there's a thought that they could also make children feel extra sleepy, forgetful, or have trouble thinking clearly after the operation, which might not be good for their overall experience. This study wants to find out if these calming medicines truly make a difference for older children, helping them to have a better experience.

To do this, the study will compare two different calming medicines, Midazolam and Dexmedetomidine, with a placebo (a dummy medicine that looks the same but has no active ingredients). By comparing these, researchers hope to understand if giving these medicines actually improves a child's experience before, during, and after surgery, or if for some, it might be better not to have them.

Key takeaways

Study explores if calming medicines help children aged 7-18 before surgery.
Compares two calming medicines (Midazolam, Dexmedetomidine) with a placebo (dummy medicine).
Focuses on how children feel before and after their operation.
Participation involves taking a medicine and completing short questionnaires.
Aims to improve future care for children undergoing surgery.

Who may be eligible?

This study is looking for children aged between 7 and 18 years who are scheduled to have an operation under general anaesthetic. Children must be able to understand and complete a questionnaire in French about how they are feeling.

There are some reasons why a child might not be able to join the study. These include if they have certain health conditions like a treated anxiety disorder, a learning disability, chronic pain (not related to the surgery site), or ADHD. Children who are already taking certain psychiatric medications or who need emergency surgery also cannot take part. If a child has recently had surgery or is scheduled for another operation soon after, they might also not be suitable.

Also, children cannot participate if they have allergies to the study medicines (Midazolam or Dexmedetomidine), or if their parents haven't both given their permission for them to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child between 7 and 18 years old?
Is your child scheduled for surgery under general anaesthesia?
Can your child understand and fill out a questionnaire in French?
Does your child have any known allergies to Midazolam or Dexmedetomidine?
Does your child have certain conditions like a treated anxiety disorder or ADHD?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will be randomly assigned to one of three groups. This means it's like a lottery – they will either receive the calming medicine Midazolam, the calming medicine Dexmedetomidine, or a placebo (a dummy medicine with no active ingredients). Neither you nor the doctors will know which treatment your child receives during the study.

Before their surgery, your child will be given their assigned medicine. After the operation, they will be asked to complete a questionnaire about how they felt during their hospital stay. There will be one follow-up questionnaire. The total duration of participation for your child will be quite short, mainly focused around the time of their surgery and the completion of these questionnaires.

Potential risks and benefits

Taking part in this study may or may not directly benefit your child, but the information gained will help doctors understand the best way to prepare children for surgery in the future. The potential risks involve receiving a medicine that might make your child feel very sleepy or a bit forgetful, or a placebo that might not reduce their anxiety as much as a calming medicine could. Like all medicines, Midazolam and Dexmedetomidine have potential side effects, which the medical team will discuss with you. You and your child have the right to withdraw from the study at any time, for any reason, without it affecting your child's medical care.

Locations (1)

Uhmontpellier
Verified postcode
Montpellier, France· Recruiting

Common questions

What are Midazolam and Dexmedetomidine?

These are medicines commonly used to help people feel calm and sleepy before medical procedures, like surgery.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real thing but contains no active ingredients. It's used to compare against the active medicines.

Will I know which medicine my child received?

During the study, neither you nor the doctors will know which medicine your child is given. This is called 'blinding' and helps ensure fair results.

How long will my child be in the study?

Your child's participation will be mainly around the time of their surgery, including taking the medicine and completing some questionnaires.

What if my child doesn't want to complete the questionnaire?

Your child is free to choose whether or not to complete the questionnaire, and their decision will be respected.

How to find out more

Sophie BRINGUIER, PHD

s-bringuierbranchereau@chu-montpellier.fr 0467338661 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.