Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05546359 | Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients | PHASE2 | COMPLETED | 453 | — | — | Jan 18, 2024 | Jun 3, 2025 | Jun 25, 2025 | 14 | United States, Canada +2 |
Defined as no vomiting/retching (absence of PONV) and no use of anti-emetic rescue medication, during the first 24 hours after completion of surgery. Subjects will be questioned and assessed.
| Arm | Type | Description |
|---|---|---|
| Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone | EXPERIMENTAL | Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone |
| Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone | EXPERIMENTAL | Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone |
| Name | Type | Description |
|---|---|---|
| Amisulpride Injection | DRUG | Dose finding treatment for continuation to phase 3 |
| Dexamethasone | DRUG | Standard of care treatment |
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 o...