Randomized clinical trial to compare the safety and effectiveness of metamizol, ibuprofen and tramadol combined with paracetamol in the treatment of pain after a surgical intervention to repair a femur fracture in patients >= 80 years admitted Convalescence Unit

Phase 1

Conditions: The medical condition being studied is post surgical pain following surgery for femur fracture in patients ? 80 years old
MedDRA version: 18.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2015-004482-88-ES

Lead Sponsor: Fundació Parc Taulí

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Patients ? 80 years
-Patients undergoing surgery for fracture of the proximal femur
-Patients candidates for oral treatment with any of the study drugs
-Patients who give their informed consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 180

Exclusion Criteria

Patients who, at the discretion of the investigator are not able to consent or participate in study assessments (Neurologic impairment such as senile dementia or other that may impair the pain assessment and response to analgesic treatment)
Patients with contraindications to the drugs studied according to the summary of product characteristics (SPC).
Patients with creatinine clearance <50 ml / min
Patients with blood dyscrasias (anemia, thrombocytopenia, agranulocytosis, aplastic anemia)
Patients with severe hypotension
Patients with hepatic cirrosis or previous upper gastrointestinal bleeding
Patients on chronic treatment with drugs that may not be administered together with the study medication according to the SPC
Patients receiving treatment with NSAIDs, metamizol or opioids in a continuous schedule with good compliance reported within the previous month before inclusion into the study. As needed consumption within the previous month are allowed.
Patients with chronic pain that could interfere with the study assessments
The physician responsible for patient's care considers that the participation of the patient in the study could be a prejudice