RecruitingPHASE2INTERVENTIONAL

Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery

This research study is investigating if a medicine called Aprepitant can help prevent children from feeling sick and throwing up after a spinal operation for scoliosis (a curved spine). Nausea and vomiting can be very uncomfortable after surgery, so doctors are looking for ways to reduce it. In this study, some children will receive Aprepitant, while others will receive a 'placebo' – a pill that looks the same but contains no medicine. By comparing these two groups, researchers hope to find out if Aprepitant is effective and safe. The study aims to make recovery more comfortable for young patients undergoing this important surgery.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

IWK Health Centre

Enrolment target

100

Start

17 Mar 2025

Estimated completion

01 Sep 2027

Spinal Fusion Nausea and Vomiting, Postoperative Anesthesia

What is this study about?

When children have an operation for scoliosis – a condition where the spine has an unusual curve – they can sometimes feel sick and vomit afterwards. This is called postoperative nausea and vomiting (PONV) and can be quite unpleasant when they are trying to recover. Doctors are always looking for better ways to make surgery and recovery as comfortable as possible for young patients.

This study is testing a medicine called Aprepitant. It's already used for other types of sickness, and researchers want to see if it can specifically help reduce feeling sick and throwing up after spinal surgery in children. They will compare it to a 'placebo,' which looks exactly like the real medicine but doesn't contain any active ingredient. This helps them know for sure if Aprepitant is making a difference, rather than something else.

The main thing the study wants to find out is whether children who take Aprepitant need less medicine to stop sickness after their operation. They will also look at how often children actually vomit, if they get headaches, and how they generally feel during their recovery.

Key takeaways

This study is testing if Aprepitant helps reduce sickness after spine surgery.
It's for young people aged 8 to 19 having specific scoliosis surgery.
Some people will get the active medicine, others a dummy pill (placebo).
Participation involves taking tablets and careful monitoring after surgery.
All medical care continues as normal, regardless of study involvement.
You can stop taking part at any time without affecting your treatment.

Who may be eligible?

This study is for children having a specific type of spinal surgery to straighten their spine, called 'posterior spinal instrumentation and fusion' for idiopathic scoliosis. This means the curve isn't caused by another condition, and the surgery will involve joining at least six parts of their spine.

To join, children must be between 8 and 19 years old on the day of their surgery, and weigh more than 40 kilograms (about 6 stone 4 pounds). This is important for preparing the correct dose of the study medicine. Both boys and girls can take part.

However, some children won't be able to join. This includes those who have had a bad reaction to Aprepitant before, or who have certain other health problems like severe ongoing illnesses. Children who are pregnant, or can't swallow medicines by mouth, also can't take part. If a parent or the child doesn't want to participate, that's perfectly fine too.

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.

Are you having surgery for idiopathic scoliosis?
Will your spinal surgery involve joining at least 6 parts of your spine?
Are you between 8 and 19 years old on the day of your surgery?
Do you weigh more than 40 kilograms (about 6 stone 4 pounds)?
Are you able to swallow medicines by mouth?
Have you not had a known allergy to Aprepitant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, during your time in hospital for surgery, you would receive either the study medicine (Aprepitant) or a dummy pill (placebo). Neither you nor your doctors would know which you received. You would take this medicine around the time of your surgery.

During your recovery in hospital, your care team would carefully record how you're feeling, including any sickness, pain, headaches, or if you need any other medicines to help with feeling sick. They will also check on your general well-being. There may be a few extra questions about how you are feeling compared to standard care, but no additional hospital visits are expected beyond what you would normally have for your surgery and recovery. The study finishes once you've recovered from your surgery and leave the hospital.

Potential risks and benefits

Taking part in this study could potentially mean you experience less sickness and vomiting after your surgery, making your recovery more comfortable. However, there's also a chance you might receive the dummy pill, or that Aprepitant doesn't help everyone. As with any medicine, there's always a small risk of side effects, which your doctor will discuss with you. You are completely free to change your mind and stop participating at any time during the study, without affecting your medical care.

Locations (1)

IWK Health Sciences Center
Verified postcode
Halifax, Canada· Recruiting

Common questions

What is scoliosis surgery?

It's an operation to correct a curve in the spine, often involving gentle straightening and joining some spinal bones together.

What is Aprepitant?

It's a medicine that can help stop feelings of sickness and vomiting. This study is checking if it helps after spine surgery.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but doesn't have any active ingredients. It helps researchers see if the real medicine is actually working.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your doctors will know which one you are receiving during the study. This is normal in research to make sure the results are fair.

Can I still get help for sickness if I'm in the study?

Absolutely. Your healthcare team will always give you extra medicine to stop sickness if you need it, regardless of whether you're in the study.

How to find out more

Mathew Kiberd, MD

mathew.kiberd@iwk.nshealth.ca 7789841329 Official trial record

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