Side effects of Tramadol and Tilidine in Cancer Pain Patients – A prospective randomized double blinded clinical trial

Not Applicable

• Conditions: cancer pain, opioid specific side effects; T88.7; R52.9; Pain, unspecified; Unspecified adverse effect of drug or medicament

• Registration Number: DRKS00004909
• Lead Sponsor: niversitätsklinikum Freiburg - Anästhesiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-13
• Study Completion: 2014-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 61

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nausea on a numeric rating scale from 0-10, daily documented per questionnaire for probands and investigators, over a period of 4 days

Secondary Outcome Measures

Name	Time	Method
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<br>pain on a numeric rating scale from 0-10, documented daily per questionnaire for probands and investigators, over a period of 4 days