Cancer Pain
Conditions
Interventions
Group A:Assess and adjust the dose every 12 hours
Group B:Assess and adjust the dose every 24 hours
Sponsors
Xuzhou Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age=18 years; 2. Patients with definite pathologically or cytologically diagnosed tumors; 3. Inpatient with cancer pain; 4. Pain scores (NRS) on admission=4 points; 5. Conscious, with a certain level of education, able to understand doctor's guidance on dosing regimen; 6. Patients must understand the study process and evaluation, agree to participation in this trial, and have signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients; 2. Patients who are allergic to oxycodone or any other ingredients in the study drug; 3. Presence of non-cancer pain or unexplained pain such as osteoarthritis pain, low back pain; 4. Acute cancer pain; 5. Patients with intractable constipation; 6. Administration of monoamine oxidase inhibitors (MAOIs) or this type of drugs within the past 2 weeks; 7. Existence of potential risks for gastrointestinal disorders and/or surgical treatment, possibly leading to gastrointestinal stenosis, blind loop or gastrointestinal obstruction. 8. Patients with unstable co-morbidities; or existence of vital organ dysfunction; 9. Patients with ongoing infection, abscess or fever symptoms; 10. Patients with liver and kidney dysfunction, e.g. creatinine=2X ULN or ALT or AST=2.5X ULN (which can be relaxed to =5X ULN in patients with liver metastases) or liver function Child Class C; 11. Patients currently receiving antiepileptic or arrhythmic drugs; 12. Patients with oxycodone or morphine contraindications, adverse drug reactions (ADRs) and drug interactions as described in product package insert or investigators brochure; 13. Patients with a history of drug or alcohol abuse; 14. Patients participating in clinical trial of another compound within 1 month before this study; 15. Patients who may change their drug combination (except for treatment of adverse opioid reactions) during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain relief rate at 24h (NRS scores at 24h decreased to=3 points); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain relief rate at 48h and 72h;Dosage of oxycodone hydrochloride sustained-release tablet at 24h, 48h and 72h;Number of breakthrough pains;Quality of life; | — |
Countries
China
Contacts
Public ContactYong Liu
Xuzhou Central Hospital
Outcome results
None listed