Postoperation pain
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, gender not limited; 2. Scheduled for elective surgery, patients who experienced moderate to severe postoperative pain, with NRS score = 4 points; 3. Patients voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. American Society of Anesthesiologists (ASA) physical condition classification of grade IV or above; 2. Patients with severe respiratory depression, such as those with oxygen saturation below 90%; 3. Patients with acute or severe bronchial asthma; 4. Patients with known or suspected gastrointestinal obstruction, including paralytic intestinal obstruction; 5. Patients allergic to any component of opioids and investigational drugs; 6. Pregnant or lactating women; 7. Patients deemed ineligible by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rates of adverse events (AE) and serious adverse events (SAE);Subjective Opioid Withdrawal Scale (SOWS) score on the second day after the last administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity scores measured in the resting state and during physical activity (or coughing) before administration, 5 minutes after administration, 30 minutes after administration, 6 hours after administration, and 24 hours after administration.;Pain relief scores at 5 minutes, 30 minutes, 6 hours, and 24 hours after administration;RASS sedation scores before administration and at 5 minutes, 30 minutes, 6 hours, and 24 hours after administration;Blood oxygen saturation before administration and at 5 minutes, 30 minutes;Incidence of opioid-related adverse events within 24 hours after the first administration;Exposure to the test drug;Information on concomitant medications,; | — |
Countries
China
Contacts
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology