Refractory cancer pain
Conditions
Interventions
Group 1:bolus
Group 2:bolus+continues
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. With written informed consent signed voluntarily by patients themselves; 2. Cancer patients aged 18-75 years old, and gender is not limited; 3. The following two criteria should be met simultaneously: the definition of patients with refractory cancer pain is based on the consensus of experts on refractory cancer pain (2017 edition); 1) The digit score of persistent pain = 4 points and / or breakthrough pain times = 3 times / day; 2) Following the relevant guidelines for cancer pain treatment, patients who used opioids alone and/or combined with adjuvant analgesics for 1-2 weeks were still unsatisfied with pain relief and/or had intolerable adverse effect; 4. Pain is mainly due to physical factors, not mental and psychological factors; 5. Patients who have a life expectancy more than one month; 6. Patients must be aware of the research process and assessment, be able to objectively describe the symptoms, follow the drug dose and visit plan.
Exclusion criteria
Exclusion criteria: 1) Those who do not meet the inclusion criteria or who are judged by the physician to be unfit for the trial; 2) During the period of clinical observation, new anti-tumor drugs or new radiotherapy regimens are being used; 3) Patients with language difficulties; cognitive impairment or mental illness; or patients with intracranial metastasis and disturbance of consciousness; or other causes of consciousness; 4) There are abnormal lab results, with obvious clinical significance, such as the creatinine = 2 fold of upper limit of normal value, or ALT or AST = 2.5 fold of upper limit of normal value (= 5 fold, to the patients with liver metastasis), or liver function of Child C grade; 5) Patients had alcohol abuse history, drug abuse history and / or opioid abuse history; 6) Patients who suffered with allergic diseases and allergic constitution; who have sensitivity to hydromorphone or similar drugs; 7) Patients with contraindication of research drugs: gastrointestinal perforation and obstruction; 8) Patients who participated in another clinical trials within 3 months before inclusion (including hydromorphone); 9) Pregnancy tests in urine were performed in premenopausal women and women during one year of menopause, and positive results were recorded before the first administration of the drug; 10) Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unable to participate in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with satisfactory pain control; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain control succeeded within 60 minutes after PCA;Pain control was successful 48 hours after PCA;Total opioid dose after completion of study;The number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control;Patient Symptom Assessment: Edmonton Symptom Scale;Follow-up time to assess changes in PGIC scores;Incidence rate; | — |
Countries
China
Contacts
Public ContactZhiying Feng
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed