Not recruiting

Study on Amisulpride, Dexamethasone Phosphate, and Ondansetron for Preventing Post-Operative Nausea and Vomiting in Children

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 studying the prevention of post-operative nausea and vomiting in children. This condition often occurs after surgery and can be uncomfortable for young patients. The study will use a medication called amisulpride, which is given through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. The purpose of the study is to evaluate how effective amisulpride is in preventing nausea and vomiting after surgery in children.

In addition to amisulpride, the study will also involve other medications such as dexamethasone phosphate and ondansetron, which are commonly used to manage nausea and vomiting. These medications will be compared to see how well they work in preventing these symptoms. Some participants may receive a placebo, which is a substance with no active medication, to help researchers understand the effectiveness of the treatments being tested.

The study will follow participants for a short period after their surgery to monitor for any signs of nausea or vomiting and to see if they need any additional medication to manage these symptoms. The goal is to find the best way to prevent post-operative nausea and vomiting in children, making their recovery from surgery more comfortable. Participants will be closely monitored for any side effects or adverse reactions to the medications used in the study.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be required to provide a signed informed consent form. This indicates the willingness of both the patient and their parents to participate in the trial.
Eligibility criteria include being a male or female patient aged from full-term birth to 17 years, undergoing non-emergency surgery under general anesthesia expected to last at least 30 minutes.
Step 2
Preparation for surgery
The patient will be prepared for surgery, which may include eye surgery, adenotonsillectomy, or otoplasty.
The surgery will be performed under general anesthesia, excluding total intravenous anesthesia with propofol.
Step 3
Administration of medications
The patient will receive medications intravenously to prevent post-operative nausea and vomiting.
The medications include amisulpride, dexamethasone phosphate, and ondansetron, all administered as a solution for infusion.
Step 4
Post-surgery observation
After surgery, the patient will be observed for 24 hours to monitor the absence of post-operative nausea and vomiting (PONV).
The primary goal is a complete response, defined as no vomiting or retching and no use of anti-emetic rescue medication during this period.
Step 5
Evaluation of outcomes
The study will evaluate the occurrence and severity of post-operative nausea, vomiting, and the use of rescue medication.
The time to emergence of PONV and other symptoms will be recorded, along with any adverse events or abnormalities.

Who can join the trial?

5 criteria

Patients can be either male or female and must be between full-term birth (in France, from one month of age) and 17 years old.
A signed informed consent form is required, which means both the patient and their parents must agree to participate in the trial.
Patients must be having a non-emergency surgery, preferably eye surgery, adenotonsillectomy (removal of tonsils and adenoids), or otoplasty (ear surgery), under general anesthesia (not using only propofol) that is expected to last at least 30 minutes.
Patients must have an ASA risk score of I-III. This is a way doctors assess the health status of patients before surgery, with I being healthy and III having more serious health issues.
For females who can have children, they must be willing and able to use a highly effective form of contraception from the time of screening until at least 48 hours after receiving the study drug. This includes methods like hormonal pills, implants, or devices, and ensuring their partner has had a successful vasectomy, or choosing to abstain from sexual activity.

Who cannot join the trial?

6 criteria

Patients who are not experiencing post-operative nausea and vomiting after surgery cannot participate. This means if you do not feel sick or vomit after surgery, you cannot join.
Patients who are not within the age range specified for the study cannot participate. This study is for children, so adults cannot join.
Patients who have any medical condition that might interfere with the study cannot participate. This means if you have other health issues that could affect the study results, you cannot join.
Patients who are taking medications that might interfere with the study cannot participate. This means if you are on certain drugs that could change how the study works, you cannot join.
Patients who have allergies to the study medication cannot participate. This means if you are allergic to the drug being tested, you cannot join.
Patients who are not able to follow the study instructions cannot participate. This means if you cannot do what the study requires, you cannot join.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hôpitaux Universitaires Strasbourg - Hôpital de Hautepierre
Verified
STRASBOURG, Alsace, France
Justus-Liebig-Universitaet Giessen
Verified
Giessen, Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn
Verified
Bonn, Germany

Trial locations

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Investigated drugs

Amisulpride: This medication is being tested to see if it can help prevent nausea and vomiting in children after surgery. It is given through an IV, which means it is administered directly into a vein. The goal is to see if it can effectively reduce the chances of feeling sick or vomiting after an operation.

What is already known about the treatment

Amisulpride – This medication is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in preventing post-operative nausea and vomiting in children. Amisulpride is primarily used as an antipsychotic, but in this context, it is being evaluated for its antiemetic properties. It works by blocking certain receptors in the brain, specifically dopamine receptors, which helps reduce nausea and vomiting. This medication is classified as an atypical antipsychotic.

Investigated diseases

Post-operative nausea and vomiting in pediatric patients – This condition occurs in children after undergoing surgery, characterized by feelings of nausea and episodes of vomiting. It typically arises due to the effects of anesthesia and surgical procedures on the body. The condition can lead to discomfort and distress in young patients, often requiring management to prevent further complications. Symptoms usually appear within the first 24 hours following surgery and can vary in severity. The condition is monitored by observing the absence of vomiting and the need for anti-emetic medication. Understanding the timing and occurrence of these symptoms is crucial for effective management.