Postoperative analgesia of impacted tooth extraction
Conditions
Interventions
Experimental group:HRS4800/4 pills
The placebo group:HRS4800 tablets of simulator /4 tablets
Sponsors
West China Stomatological Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years, no gender limitation; 2. Two or more third molars (at least one impacted mandibular tooth) should be removed during the operation; 3. NRS score >= 5 at any time within 4 hours after surgery; 4. Able to correctly understand research procedures and methods and abide by research regulations; 5. Voluntarily sign informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1.The use of other drugs that affect the analgesic effect is shorter than 5 half-lives of the drug before randomization (according to the actual drug instructions, drugs with unknown half-lives shall be eluted within 7 days), including but not limited to: Bureau hemp drugs (except under plans), nonsteroidal anti-inflammatory drugs (NSAIDs), opioid excited/antagonists, sedative hypnotic drugs (such as diazepam, phenobarbital, etc.), monoamine oxidase inhibitors, tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs) (e.g., paroxetine, dorothy dean, fluoxetine, etc.), serotonin, and Norepinephrine reuptake inhibitors (SNRIs) (minacillin, duloxetine, venlafaxine, etc.), methylphenidate hydrochloride (Ritalin), other antipsychotic drugs, etc.; 2.Using sodium channel blockers within 5 half-lives of the drug before randomization (will be subject to the actual instruction, the half-life of the unknown drugs according to the elution 7 days), including but not limited to: anti-arrhythmic drugs (such as quinine butyl, propafenone, etc.), and antiepileptic drugs (carbamazepine, phenytoin sodium, lamotrigine, etc.), tetrodotoxin, etc; 3.Complications such as infection at the site of oral surgery; 4.Hypertension during the screening period is defined as systolic blood pressure >= 140mmHg and/or diastolic blood pressure >= 100mmHg (retest can be carried out if hypertension is detected for the first time, and the mean value of three consecutive measurements reaches systolic blood pressure >= 140mmHg and/or diastolic blood pressure >= 100mmHg shall be excluded, and the interval between two adjacent measurements shall be at least 5min); 5.Hypotension during screening period, defined as systolic blood pressure = 450ms, female >= 470ms) or other clinically significant ecg abnormalities (such as sinus bradycardia (= 120bpm), sick sinus syndrome, grade II type II or III ATrioventricular block without pacemaker installation, etc.); 10.There are obvious abnormal laboratory tests during screening period: (1)Hemoglobin (Hb) = 1.5xULN (upper limit of normal value); (3)Serum aspartate aminotransferase (AST) >= 1.5xULN; (4)Serum total bilirubin (TBIL) >= 1.5xULN; (5)Serum creatinine (Cr) >= 1.5xULN; (6)Random blood glucose (GLU) >= 11.1mmol/L; (7)PT>ULN+ 3S and/or APTT>ULN + 10 s; (8)Positive for human immunodeficiency virus antibody (HIV-AB), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-AB), syphilis antibody; 11.Known allergy or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) or lidocaine or whole milk; 12.Pregnant women (including women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SPID8h; | — |
Countries
China
Contacts
Public ContactShi Bing
West China Stomatological Hospital, Sichuan University
Outcome results
None listed