cancer pain, opioid specific side effects T88.7 R52.9
Conditions
Interventions
Group 1: Valoron (tilidine/naloxone), 2x 100/8mg/day p.o. (prolonged-release tablet), for 4 days
Group 2: Tramadol (tramadol), 2x 100mg/day p.o. (prolonged-release tablet), for 4 days
Sponsors
Universitätsklinikum Freiburg - Anästhesiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: cancer pain patients with moderate to severe pain, age > 18 years, sufficient mental, physical and linguistic abilities to cooperate at the study, signed informed consent
Exclusion criteria
Exclusion criteria: contraindication for tilidine or tramadol (allergy against a component of tilidine or tramadol, pregnancy or lactation, severe hepatic or renal impairment (CHILD C; GFR < 15ml/min), seizure disorder, drug abuse, taking of MAO-inhibitors), acute interventional pain (e.g. postoperative pain), indication for pain therapy with opioids of WHO step 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| nausea on a numeric rating scale from 0-10, daily documented per questionnaire for probands and investigators, over a period of 4 days | — |
Secondary
| Measure | Time frame |
|---|---|
| other side effecs on a numeric rating scale from 0-10, documented daily per questionnaire for probands and investigators, over a period of 4 days pain on a numeric rating scale from 0-10, documented daily per questionnaire for probands and investigators, over a period of 4 days | — |
Countries
Germany
Contacts
Public ContactKlaus Offner
Universitätsklinikum Freiburg - Anästhesiologie
Outcome results
None listed