Cancer pain
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subjects volunteered and signed the informed consent of the trial; 2. Patients with cancer pain, aged 18 or more, with no gender limit; 3. Patients with cancer pain and NRS score >= 4 in the past 24 hours; 4. Patients who did not receive radiotherapy during the observation period; 5. Patients who need chemotherapy, long-term hormone therapy, targeted therapy or bisphosphonate therapy have received stable anti-tumor therapy before randomization; 6. Patients or their nursing staff can fill in the survey form; 7. Patients without mental illness who can correctly understand and cooperate with the medication guidance of medical staff; 8. Patients with no history of allergy to narcotic drugs or opiate addiction; 9. Patients with ECOG-ps <= 2; 10. Did not participate in any drug trial within 1 month before the trial.
Exclusion criteria
Exclusion criteria: 1. The patient was diagnosed with non cancerous pain or unexplained pain; 2. Patients with postoperative pain; 3. Paralytic intestinal obstruction; 4. Patients with brain metastases (except those with stable control of brain metastases); 5. Patients with allergic diseases and allergic constitution; those with similar drug structure in the study; and; 6. Patients with abnormal and clinically significant laboratory results, such as creatinine >= 2 times of the upper limit of normal value, ALT or AST >= 2.5 times of the upper limit of normal value (liver metastasis or primary liver cancer >= 5 times of the upper limit of normal value), or child C grade of liver function; 7. Pregnant and lactating women; subjects with pregnancy plan within one month after the trial (including male subjects); 8. Opioid addicts; 9. Patients with cognitive impairment; 10. Patients with severe skin edema, or poor peripheral and subcutaneous circulation, it is not suitable to implant subcutaneous analgesia pump.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the time of successful titration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of breakthrough pain within 24 and 48 hours;The average pain scores at 24 hours and 48 hours;Number of patients with successful titration at 24 hours and 48 hours;Patient Quality of Life Assessment: Chinese version of the Edmonton Symptom Assessment System; | — |
Countries
China
Contacts
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology