The use of IV Tramadol (Contramal) versus immediate release Tramadol (Tradonal odis) in the postoperative period after knee surgery in a day surgery setting. A raondomised , open label
Phase 1
- Conditions
- Male and female patients undergoing elective knee surgery in a day surgery setting.
- Registration Number
- EUCTR2007-006224-35-BE
- Lead Sponsor
- niversity Hospitals Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Physical status ASA I-II-III
- Patients aged 18 to 70
- elective knee arthroscopy in the day hospital centre;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- ASA IV
- History of PONV
- The presence of known allergies to tramadol
- Preoperative use of MAO's or opiods
- Recent history of s
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the postoperative analgesia after knee surgery povided by immediate release oral tramadol compared to intravenous tramadol.;Secondary Objective: The secondary objectives of this trial are to compare the two analgesic routes:<br>- speed of effect<br>- side effects<br>- evaluation of patient satisfaction<br>- time of discharge<br>- to compare the total cost of both medications;Primary end point(s):
- Secondary Outcome Measures
Name Time Method