Moderate to severe chronic pain
Conditions
Interventions
Oxycodone sustained-release tablets group:Use oxycodone sustained-release tablets for analgesic treatmen
Hydromorphone Sustained-release Tablets Group:Use hydromorphone sustained-release tablets for analgesic treatment
Sponsors
Shenzhen Nanshan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age range: 18-80 years old; 2.Patients with persistent pain and NRS (0-10 points) score >= 4 in the past 24 hours; 3.The patient has no cognitive impairment or mental illness; 4.Can correctly understand and cooperate with the medication guidance of medical staff; 5.ECOG-PS <= 3 points; 6.Patients who have not received treatment with the investigational drug within 14 days prior to the trial; 7.The subjects voluntarily and sign an informed consent form;
Exclusion criteria
Exclusion criteria: 1.There are contraindications for experimental drugs, such as patients with paralytic intestinal obstruction, chronic obstructive respiratory disease, and pulmonary heart disease; 2.Individuals allergic/addicted to opioid drugs; 3.Abnormal and clinically significant laboratory results, such as creatinine >= 2 times the upper limit of normal, ALT or AST >= 2.5 times the upper limit of normal (in patients with liver metastases or primary liver cancer >= 5 times the upper limit of normal), or Child C liver function; 4.Those who have undergone surgical procedures within the 4 weeks prior to the experiment, or those who plan to undergo surgical procedures during the study period; 5.Severe cognitive impairment; 6.Patients who cannot take oral medication; 7.Uncontrollable nausea and vomiting; 8.Alcoholics patients; 9.Used monoamine oxidase inhibitors within 14 days prior to randomization; 10.Pregnant and lactating women; Subjects with pregnancy plans within one month after the experiment (including male subjects); 11.Participate in drug trials (including the investigational drug) within one month prior to the trial; 12.Patients who have received pain related treatments such as radiation therapy, nuclear therapy, or chemotherapy at the site of pain within 7 days prior to randomization and trial; 13.Diseases and conditions that other researchers consider ineligible for inclusion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event incidence rate;Proportion of patients with effective pain relief; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction with pain control;Patient's quality of life;Patient's frequency of breakthrough pain and nighttime pain outbreaks;Daily rescue medication dosage and total daily opioid dosage;Number of patients with significant pain relief after 14 days of treatment;Patient's medication adherence;Liver and kidney function test indicators; | — |
Countries
China
Contacts
Public ContactDonglin Xiong
Shenzhen Nanshan People's Hospital
Outcome results
None listed