pain
Conditions
Interventions
Test group:Anrikefon
Sponsors
The Central Hospital of Wuhan
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary agreement to participate in this trial and signed informed consent; 2. Age >=18 and =18 kg/m² and =1 hour and <=8 hours; 7. Women of childbearing potential and male participants must agree to use protocol-specified contraceptive measures from the time of informed consent signing through 30 days after drug administration (including partners of male participants);
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or contraindication to opioid analgesics or other medications that may be used during the trial period; 2. History or evidence of any of the following diseases prior to screening: 1) Cardiovascular diseases: Uncontrolled hypertension [SBP >160 mmHg and/or DBP >100 mmHg], aneurysm, severe arrhythmia, heart failure, Adams-Stokes syndrome, New York Heart Association (NYHA) functional class =III, severe superior vena cava syndrome, pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction within 6 months prior to screening, history of tachycardia/bradycardia requiring medical treatment, second- to third-degree atrioventricular block (excluding subjects with pacemakers), severe valvular heart disease (severe stenosis or regurgitation); 2) Respiratory diseases: Severe chronic obstructive pulmonary disease (COPD), acute exacerbation of COPD, severe airway stenosis, laryngeal/pharyngeal mass, history of (broncho)tracheoesophageal fistula or airway tear, severe respiratory tract infection within 2 weeks prior to screening; 3) Neurological and psychiatric disorders: Craniocerebral injury, convulsions, intracranial hypertension, cerebral aneurysm, history of cerebrovascular accident; schizophrenia, mania, mental confusion, long-term use of psychotropic medications, history of cognitive dysfunction; depression, anxiety, history of epilepsy; 4) Major surgery within 3 months prior to screening that the investigator determines may affect postoperative pain assessment; 3. Use of any of the following medications or treatments during the screening period: 1) Time interval from randomization to last use of opioid or non-opioid analgesics (such as acetaminophen, aspirin [daily dose >100 mg], indomethacin, diclofenac, parecoxib sodium, and other nonsteroidal anti-inflammatory drugs [NSAIDs]) shorter than 5 half-lives or duration of drug efficacy (whichever is longer); 2) Continuous use of opioid analgesics for more than 10 days within 3 months prior to screening for any reason; 3) Use of medications with unclear half-lives that may affect analgesic efficacy within 14 days prior to randomization, or use of medications affecting analgesic efficacy prior to randomization with last administration within 5 half-lives prior to randomization (based on actual drug labeling), including but not limited to: sedative-hypnotics (benzodiazepines [triazolam, diazepam, midazolam, etc.], non-benzodiazepines [zolpidem, zopiclone, zaleplon, etc.]), anesthetic sedatives (sevoflurane, anesthetic ether, nitrous oxide, thiopental sodium, ketamine, etomidate, etc.), glucocorticoids (dexamethasone hydrochloride, methylprednisolone, etc.), antiepileptics (carbamazepine, sodium valproate, etc.), anxiolytics (chlordiazepoxide, diazepam, etc.), antidepressants (imipramine, amitriptyline, etc.), and traditional Chinese medicines or proprietary Chinese medicines with analgesic or sedative effects; 4) Requirement for antineoplastic drugs and treatments from 14 days prior to randomization through end of follow-up, including but not limited to chemotherapeutic agents, targeted therapies, and traditional Chinese medicines; Time interval from randomization to last use of diuretics or combination drugs containing diuretic components shorter than 5 half-lives or duration of drug efficacy (whichever is longer); 4.Screening laboratory values meeting any of the following criteria: 1) White blood cell count <3.0×10?/L; 2) Platelet co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time-weighted pain intensity difference (SPID) from 0 to 48 hours after the first postoperative dose in each group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction score for postoperative pain management;The incidence of vomiting, moderate-to-severe nausea, and nausea during the 48-hour period after the first postoperative dose in both groups;Patient-controlled analgesia utilization;The time-weighted pain intensity difference (SPID) from 0 to 24 hours after the first postoperative dose in each group;Use of rescue analgesics;Difference in pain intensity at rest between the two groups at each evaluated time point following the first postoperative dose;Total antiemetic usage and utilization rate during the 48-hour period after the first postoperative dose in both groups; | — |
Countries
China
Contacts
Public ContactChen Jingli
The Central Hospital of Wuhan
Outcome results
None listed