Using amisulpride to prevent nausea and vomiting after surgery in children

Randomized, Double-blind, Phase 2/3 Study of IV Amisulpride as Prevention of Post-operative Nausea and Vomiting in Pediatric Patients

This study is testing if a medication called amisulpride can help prevent nausea and vomiting after surgery in children aged from birth to 17 years.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 410 (estimated)
• Ages: 2 Months to 17 Years
• Sex: All
• Sponsor: Acacia Pharma Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 14 sites (Sheffield, Alabama and 13 other locations)
• Trial ID: NCT05546359 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind clinical trial evaluating the effectiveness of intravenous amisulpride for preventing post-operative nausea and vomiting (PONV) in pediatric patients. The study involves children aged from full-term birth to 17 years undergoing non-emergency surgeries, such as eye surgery or adenotonsillectomy, under general anesthesia. Participants will receive either amisulpride or dexamethasone to assess the efficacy of amisulpride in reducing PONV. The trial aims to provide a safer post-operative experience for children by minimizing nausea and vomiting.

Who should consider this trial

Good fit: Ideal candidates include children aged from full-term birth to 17 years who are scheduled for non-emergency surgeries under general anesthesia.

Not a fit: Patients undergoing emergency surgeries or those with ASA risk scores above III may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of post-operative nausea and vomiting in pediatric patients, improving their recovery experience.

How similar studies have performed: Previous studies have shown promising results with similar antiemetic approaches, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Male or female patients aged from full-term birth to 17 years of age
2. Signed informed consent form and/or assent and willingness of patient and parents to participate in the trial
3. Patients undergoing non-emergency surgery, preferentially eye surgery, adenotonsillectomy or otoplasty, under general anesthesia (other than total intravenous anesthesia with propofol) expected to last at least 30 minutes from induction of anesthesia to removal of Endotracheal tube (ETT) or Laryngeal mask airway (LMA)
4. American Society of Anesthesiologists (ASA) risk score I-III
5. For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (as defined in ICH M3 guidance, e.g., true (not periodic) abstinence from sexual intercourse, surgical sterilization (of subject or partner), combined oral contraceptive pill, or any other method or combination of methods with a failure rate generally considered to be \<1% per year) between the date of screening and at least 48 hours after administration of study drug.

Exclusion Criteria:

1. Patients scheduled to undergo transplant or Central Nervous System (CNS) surgery
2. Patients scheduled to receive only a local anesthetic and/or regional neuraxial (intrathecal or epidural) block (without general anesthesia) or to receive general anesthesia involving total intravenous anesthesia (TIVA) with propofol
3. Patients who, in the opinion of the Investigator, are expected to remain ventilated for a significant period after surgery
4. Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed
5. Patients who are expected to receive systemic pre/peri-operative corticosteroid therapy other than as anti-emetic prophylaxis
6. Patients receiving amisulpride for any indication within the 2 weeks prior to randomization
7. Patients known to be allergic to amisulpride or any of the excipients of amisulpride drug product; or to dexamethasone or ondansetron
8. Patients with a significant ongoing history of vestibular disease or dizziness
9. Patients being treated with regular anti-emetic therapy (dosed at least three times per week), which is still ongoing less than 1 week prior to screening
10. Patients being treated with levodopa, or any other dopamine D2-agonist
11. Patients who are pregnant or breast feeding
12. Patients with congenital long QT interval (QT) syndrome
13. Patients with a tumor of the anterior pituitary
14. Patients who have received emetogenic anti-cancer chemotherapy in the previous 4 weeks
15. Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
16. Patients who have previously participated in this study or who have participated in another interventional clinical study involving pharmacological therapy within the previous 28 days (or longer exclusion period, if required by national or local regulations)
17. Where local laws/regulations require: patients under legal protection

Where this trial is running

Sheffield, Alabama and 13 other locations

• Helen Keller Hospital — Sheffield, Alabama, United States (Recruiting)
• Emory Healthcare - Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
• University of Minnesota Masonic Children's Hospital — Minneapolis, Minnesota, United States (Recruiting)
• The Children's Hospital of Philadelphia (CHOP) — Philadelphia, Pennsylvania, United States (Recruiting)
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
• The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)
• McGill University Health Centre - The Montréal Children's Hospital — Montréal, Quebec, Canada (Recruiting)
• HCL - Hôpital Mère Enfant — Bron, France (Recruiting)
• CHU Strasbourg - Hopital Hautepierre — Strasbourg, France (Recruiting)
• Universitätsklinikum Würzburg — Würzburg, Bayern, Germany (Recruiting)
• Ambulantes Operieren Marburg — Marburg, Hessen, Germany (Recruiting)
• Universitaetsklinikum Giessen und Marburg GmbH — Marburg, Hessen, Germany (Recruiting)
• Universitaetsklinikum Bonn - Klinik für Anaesthesiologie & Operative Intensivmedizin — Bonn, Nordrhein-Westfalen, Germany (Recruiting)
• Helios Klinikum Aue — Aue, Germany (Not_yet_recruiting)

Study contacts

• Principal investigator: Kumar Belani, MD — University of Minnesota Masonic Children's Hospital
• Study coordinator: Gabriel Fox, MB BChir

Conditions Nausea and Vomiting, Postoperative