cancer breakthough pain
Conditions
Interventions
study group :Hydromorphone Hydrochloride Injection
Contral group:Morphine Hydrochloride Injection
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) The patients voluntarily and signed the informed consent form for this trial; 2) Cancer patients aged 18-65 years; 3) Patients are receiving analgesic treatment, the basis of pain treatment opioid oxycodone hydrochloride sustained-release tablets, can be combined with other non-opioid analgesics, long-term regular use of = 1 week; breakthrough pain available immediate release morphine, acetaminophen, tramadol and acetaminophen, oxycodone and acetaminophen, and other short-acting drugs or parenteral injection of morphine, oxycodone injection. 4) The Background pain intensity VAS=4 and cancer breakthrough pain occurs 1-3 times/day during the past 3 days; 5) Patients can follow the drug dose and visit plan; 6) Patients without mental illness, consciousness, normal language skills, can understand the VAS score, and with the treatment and evaluation.
Exclusion criteria
Exclusion criteria: 1) The pain caused by non-tumor; 2) The general situation is poor, can not objectively describe the symptoms; 3) Patients with body mass index (BMI)= 31 or BMI = 13 (BMI normal range of 18.5-23.9); 4) Patients with Severe infection, airway obstruction or tissue hypoxia, SPO2 50 mmHg; 5) Allergies or research drug structure similar to drug sensitivity history; 6) Patients who are undergoing radiotherapy; 7) Chemotherapy is expected during the trial, and the chemotherapy regimen will easily lead to nausea and vomiting; 8) Patients with elevated serum levels of aminotransferases and bilirubin up to 2 times the upper limit of normal; Patients with elevated serum creatinine up to 2 times the upper limit of normal; or Patients with grade 3 hypertension (systolic BP = 180 mmHg or diastolic BP = 110 mmHg) ; Or poor blood glucose control, fasting blood glucose higher than 10mmol / L of patients; 9) Patients with contraindications to test medications (respiratory depression, paralytic ileus, confusion); 10) Pregnant, lactating women; or Subjects who have a pregnancy plan within 1 month after the trial (includeing male subjects); 11) Patients with mental disorders or those judged by the investigator to be unfit to participate in this study; 12) A history of drug abuse; 13) The expected survival time is less than 1 months; 14) The patients who participated in the drug test within 3 months before the trial (including the test drugs); 15) Sponsors or researchers who are directly involved in the trial or their family members; 16) Non cooperative treatment and evaluators; 17) Patients who used monoamine oxidase inhibitors for nearly 1 week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain relief rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| onset time of analgesia;to achieve the best analgesic effect time;The duration of the best analgesic effect;The duration of effective analgesia relief;satisfaction of patients and their families after the trial; | — |
Countries
China
Contacts
Public ContactJifeng Feng
Jiangsu Cancer Hospital
Outcome results
None listed