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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Hgzfmt Keuzbmbq Agd Ghpi	Aue	Germany
Mzt Azjrxuszzv Opczruafr Mltbqmt	Marburg	Germany
Uncivrpprrtdidptyxdek Wcnahctil Awp	Wuerzburg	Germany
Hwgitzie Uisubohuyeavre Sjvflfuyiz &xnwmoo Hycxtai dl Hjhkigzwzjm	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	26.06.2023
Germany	Not recruiting	26.06.2023

Trial locations

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.

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.

Trial ID:

2024-518778-15-00

Protocol code:

DP-10027

NCT ID:

NCT05546359

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?