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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06785571 | The Evaluation of the Effectiveness and Safety of Nalbuphine Hydrochloride Injection for Analgesia in ICU Patients: A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial | PHASE2 | RECRUITING | 204 | — | — | Aug 30, 2023 | Oct 31, 2025 | Jan 21, 2025 | 1 | China |
The analgesic success is determined as 1) no use of rescue analgesic medication and 2) at least 70% of the time with CPOT ≤ 2 points
| Arm | Type | Description |
|---|---|---|
| lower loading dose of Nalbuphine hydrochloride for step 1 | EXPERIMENTAL | Nalbuphine hydrochloride injection, a loading dose of 4 mg administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0\~5.0mg/h) |
| higher loading dose of Nalbuphine hydrochloride for step 1 | EXPERIMENTAL | Nalbuphine hydrochloride injection, a loading dose of 6 mg administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0\~5.0mg/h) |
| Hydromorphone hydrochloride injection for step 1 | ACTIVE_COMPARATOR | Hydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h) |
| The optimal loading of Nalbuphine hydrochloride injection for step 2 | EXPERIMENTAL | Nalbuphine hydrochloride injection: a loading dose determined after step 1 administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0\~5.0mg/h) |
| Hydromorphone hydrochloride injection for step 2 | ACTIVE_COMPARATOR | Hydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h) |
| Name | Type | Description |
|---|---|---|
| Nalbuphine hydrochloride injection | DRUG | a loading dose of Nalbuphine hydrochloride injection administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0\~5.0mg/h) |
| Hydromorphone hydrochloride injection | DRUG | A maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5\~3.0mg/h) |
Inclusion Criteria: 1. ICU patients who are intubated are expected to require mechanical ventilation for more than 6h 2. patients or their guardians have a full understanding of the purpose and significance of this trial, and voluntarily participate in this clinical trial and sign an informed conse...