post-operative nausea and vomiting in pediatric patients MedDRA version: 21.1 Level: LLT Classification code 10036901 Term: Prophylaxis against postoperative nausea and vomiting System Organ Class: 100000004865
Conditions
Sponsors
Acacia Pharma Ltd
Eligibility
Sex/Gender
All
Inclusion 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 under general anesthesia, involving at least one volatile inhalational anesthetic, planned to last at least 30 minutes from induction of anesthesia to removal of endotracheal tube or laryngeal mask airway 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., abstinence from sexual intercourse, surgical sterilization (of subject or partner), combined oral contraceptive pill, a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner’s use of a condom, or any other method or combination of methods with a failure rate generally considered to be =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients scheduled to undergo transplant or 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, ondansetron or dexamethasone, or any of the excipients of those drug products 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 11. Patients who are pregnant or breast feeding Patients with congenital long 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. For patients < 1 year of age, history of gestation age less than 36 weeks or birth weight less than 2500 grams 16. Any other concurrent disease or illness that, in the opinion of the Investigator makes the patient unsuitable for the study 17. 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) 18. Where local laws/regulations require: patients under legal protection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To evaluate the efficacy of IV amisulpride in the prevention of PONV (Prevention of post-operative nausea and vomiting) in pediatric patients.;Secondary Objective: -To determine a suitable dose of IV amisulpride for PONV prophylaxis in pediatric patients. -To assess the safety and tolerability of IV amisulpride in pediatric patients. -To characterize the pharmacokinetics of IV amisulpride in pediatric patients -Safety: The nature and frequency of adverse events and laboratory and ECG abnormalities -Key pharmacokinetics parameters;Primary end point(s): Complete Response (absence of PONV), defined as no vomiting/retching and no use of anti-emetic rescue medication, during the first 24 hours after completion of surgery;Timepoint(s) of evaluation of this end point: First 24 hours after completion of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: - Occurrence of post-operative vomiting/retching - Use of rescue medication - Occurrence and severity of post-operative nausea - Time to emergence of PONV - Time to emergence of vomiting/retching, significant nausea, and rescue medication, individually Different variables during different time ranges after the end of surgery (0-2 h, 2-6 h and 6-24 h) - The above variables in the sub-groups of patients who did and did not receive opioid analgesia Safety: The nature and frequency of adverse events and laboratory and ECG abnormalities Key pharmacokinetics parameters;Timepoint(s) of evaluation of this end point: First 24 hours after completion of surgery | — |
Countries
Canada, France, Germany, United States
Contacts
Public ContactClinical Trials Information
Acacia Pharma Ltd
Outcome results
None listed