The medical condition being studied is post surgical pain following surgery for femur fracture in patients ? 80 years old MedDRA version: 18.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863
Conditions
Interventions
Product Name: Ibuprofeno
Pharmaceutical Form: Tablet
INN or Proposed INN: IBUPROFEN
Other descriptive name: IBUPROFEN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
Fundació Parc Taulí
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the safety of three analgesic regimens for the treatment of pain in patients ? 80 years after femur fracture surgery.;Secondary Objective: To compare, in qualitative terms, the safety of analgesic treatment between metamizol, ibuprofen and tramadol in elderly patients with fracture of the proximal femur during the first week and at weeks 2, 3 and 4 after surgery. -To compare, in quantitative terms, the safety of analgesic treatment between metamizol, ibuprofen and tramadol in elderly patients with fracture of the proximal femur at weeks 2, 3 and 4 postsurgery. -To compare the analgesic effectiveness of the three treatments up to week 4 postsurgery.;Primary end point(s): Proportion of complications related to the study medication during the first week after surgery, assessed as the frequency in each group of, at least, one of the following: -Adverse events of moderate intensity in any of the following signs and symptoms: high blood pressure, edema, dyspepsia, nausea, vomiting, bleeding, worsening of respiratory function, confusion, agitation, decreased level of consciousness, or laboratory abnormalities in the blood count or biochemical determinations of liver function, kidney or ions. -Serious adverse events of any kind. -withdrawal of the study medication due to any reason different from insufficient pain control;Timepoint(s) of evaluation of this end point: One week after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Efficacy variables: Weekly percentage of pain measures < 3 on a 11 item Verbal Pain Scale (VPS) (0 = no pain to 10 = worst pain imaginable), up to week 4 postsurgery. Summary of different parameters derived from the VPS measures. Duration of treatment with the assigned study regimen Number of doses of painkillers received daily Use of rescue medication Withdrawal from the study because of insufficient pain control Security variables: Frequency of appearance in the first 4 weeks: Adverse events of mild intensity in any of the following signs and symptoms: blood pressure, edema, dyspepsia, nausea, vomiting, bleeding, worsening of respiratory function, confusion, agitation, decreased level of consciousness or laboratory abnormalities in the blood count or the biochemical determinations of liver function, kidney or ions. Adverse events of moderate intensity in any of the following signs and symptoms: high blood pressure, edema, dyspepsia, nausea, vomiting, bleeding, worsening of respiratory function, confusion, agitation, decreased level of consciousness or laboratory abnormalities in the blood count or the biochemical determinations of liver function, kidney or ions . Serious adverse events of any kind. Stopping the assigned study medication for any reason. Withdrawal from the study for any reason other than poor pain control. Frequency of complications to the study medication during weeks 2, 3 and 4 after surgery, assessed as the frequency in each group of at least one of the following: Adverse events of moderate intensity in any of the following signs and symptoms: high blood pressure, edema, dyspepsia, nausea, vomiting, bleeding, worsening of respiratory function, confusion, agitation, decreased level of consciousness, or laboratory abnormalities in the blood count or in biochemical determinations of liver function, kidney or ions. Serious adverse events of any kind Stopping the assigned study medication for any reason.;Timepoint(s) of eva | — |
Countries
Spain
Contacts
Public ContactOficina de Recerca
Hospital Universitari Parc Taulí
Outcome results
None listed