RecruitingPHASE2INTERVENTIONAL

Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery

This study is investigating if a medicine called dexmedetomidine, given directly into the vein during surgery, can help children aged 1 to 7 feel less pain afterwards. Children having common operations like hernia repair will be involved. The researchers want to see if this medicine, when used with standard local pain relief, can reduce pain, lower the need for strong pain medicines, and prevent problems like agitation after surgery. They will also look at how quickly children recover, their behaviour, and their parents' satisfaction. Half the children will receive dexmedetomidine, and the other half will receive a dummy medicine (placebo), without anyone knowing which they're getting, to ensure a fair comparison.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Hospital, Montpellier

Enrolment target

200

Start

03 Feb 2025

Estimated completion

03 Jul 2028

Anesthesia Pediatric Surgery

What is this study about?

When children have surgery, managing their pain afterwards is really important. Strong pain can make recovery harder and, in some cases, might even lead to long-lasting pain. We also want to avoid using too many strong painkillers, as they can have side effects. Another concern after surgery in children can be something called 'emergence delirium,' where they might become very confused or agitated as they wake up from anaesthesia.

This study is looking at a medicine called dexmedetomidine. Doctors already know that dexmedetomidine can help children feel sleepy and can also help with pain. The researchers believe that giving this medicine during surgery, alongside the usual local pain relief (like numbing injections), could make a big difference. They hope it will help reduce pain, mean children need fewer strong painkillers, and might even prevent that agitated feeling when waking up.

The main goal is to see if dexmedetomidine helps children have less pain after their operation. The study will also compare how much strong pain medicine is needed, how often children become agitated after surgery, how long they stay in the recovery room, any behaviour changes, parents' happiness with their child’s recovery, and how their child's overall well-being is affected. This is a "Phase 2" study, meaning it's a step towards understanding if this treatment works and is safe in a focused group.

Key takeaways

Tests a medicine (dexmedetomidine) to reduce children's pain after surgery.
Aimed at children aged 1-7 having specific common operations.
Compares dexmedetomidine to a dummy medicine (placebo).
Looks at pain levels, use of strong painkillers, and recovery.
Requires follow-up questionnaires for up to 6 months.
Participation is completely voluntary.

Who may be eligible?

This study is looking for children aged between 1 and 7 years old, both boys and girls. They must be having certain routine operations, specifically for conditions like undescended testicles (orchidopexy) or groin hernias/fluid collections (inguinal hernia or hydrocele cure). These operations are typically done as day surgery, meaning the child goes home the same day. For safety, children must receive specific local pain relief injections during their operation, known as a TAP block or pudendal block.

To be included, the child must be generally healthy (classified as ASA 1 or 2 by a doctor), covered by national health insurance, and their parents must be able to speak, read, and understand French, as they will need to fill out questionnaires and understand consent forms. Importantly, parents must give their clear permission for their child to join the study.

Children cannot join if they are outside the age range (under 1 or over 7), have allergies to numbing medicines or dexmedetomidine, or have conditions that would make local pain relief or dexmedetomidine unsafe. This includes serious heart problems, blood clotting issues, or certain brain conditions. Children who have already been part of a similar study or whose parents do not wish to take part will also not be included.

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 aged between 1 and 7 years old?
Is your child having a planned hernia repair or undescended testicle surgery?
Is your child generally healthy (no serious ongoing medical conditions)?
Are you able to speak, read, and understand French?
Will your child be having local pain injections (TAP or pudendal block) for their surgery?
Does your child have any known allergies to medicines used for numbing or to dexmedetomidine?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will be randomly assigned to one of two groups: one group will receive dexmedetomidine, and the other will receive a dummy medicine (placebo). Neither you, your child, nor the medical team will know which one your child is receiving. The medicine (or placebo) will be given through a drip at the very start of the operation.

After the surgery, you and your child will be asked to complete some questionnaires. These will be at several points: on Day 1 (the day after surgery), then again at Week 1, Month 3, and Month 6 after the operation. These questionnaires will ask about your child's pain levels, their behaviour, and their overall well-being and recovery. Each questionnaire session may take a short amount of time.

Potential risks and benefits

Participating in this study might offer potential benefits, such as better pain control for your child after surgery or a reduced need for strong painkillers. However, there's no guarantee of direct benefit for your child, as this is a research study. As with any medical treatment, there are potential risks and side effects associated with dexmedetomidine, which your doctor will explain in detail, and these will be carefully monitored. The placebo group will receive standard care. You are free to withdraw your child from the study at any time without affecting their medical care.

Locations (1)

UH of Montpellier
Verified postcode
Montpellier, France· Recruiting

Common questions

What is dexmedetomidine?

It's a medicine often used in hospitals to help patients feel calm and to reduce pain, especially during and after surgery.

Will my child know if they are getting the study medicine or a dummy medicine?

No, neither you, your child, nor the doctors will know which medicine is given. This helps ensure the study results are fair and unbiased.

What kind of operations are included in this study?

The study includes children having common operations like hernia repairs or surgery for undescended testicles, typically done as day surgery.

How long will my child need to be followed up?

You'll be asked to complete questionnaires about your child's recovery and well-being at Day 1, Week 1, Month 3, and Month 6 after the surgery.

Can I change my mind about my child participating?

Yes, you have the right to withdraw your child from the study at any time, and their medical care will not be affected.

How to find out more

Julien PICO, MD

j-pico@chu-montpellier.fr +33 7 88 01 44 14 Official trial record

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