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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-006224-35-BE

Enrollment

Registered

2007-11-20

Start date

2007-12-11

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male and female patients undergoing elective knee surgery in a day surgery setting.

Interventions

Trade Name: Contramal Pharmaceutical Form: Injection* INN or Proposed INN: TRAMADOL HYDROCHLORIDE CAS Number: 22204882 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Conce

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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: - speed of effect - side effects - evaluation of patient satisfaction - time of discharge - to compare the total cost of both medications;Primary end point(s):	—

Measure

Time frame

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: - speed of effect - side effects - evaluation of patient satisfaction - time of discharge - to compare the total cost of both medications;Primary end point(s):

—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026