elective orthopedic surgery (hip arthroplasty) MedDRA version: 7.0 Level: PT Classification code 10020096
Conditions
Interventions
Trade Name: Enantyum
Product Name: Enantyum
Pharmaceutical Form: Tablet
INN or Proposed INN: Dexketoprofeno trometamol
CAS Number: 156604-79-4
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Laboratorios Menarini, S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of both sexes, aged between 18 and 70 years inclusively. 2. Patients with body weigth between 60 and 100 kg, both included. 3. Patients after elective orthopaedic surgery (hip replacement) with spinal anesthesia. 4. Patients with grade I, II or III ASA physical status. 5. Patients capable of understanding the information provided for patients and who have given their written informed consent. 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: 1. Patients with a history of peptic ulcer, gastric disease due to NSAIDs or gastrointestinal bleeding. 2. Patients with asthma or a history of bronchospasm, nasal polyps or angioedema. 3. Patients with moderate-severe or decompensated renal, hepatic, or respiratory diseases. 4. Presence of systemic infection or local infection on the surgical site before surgery. 5. Patients with non-controlled diabetes, heart failure or hypertension. 6. Patients with coagulation disorders. 7. Patients currently being treated for any type of psychiatric disease. 8. Patients with brain injury or increased intracranial pressure. 9. Patients with hypothyroidism, adrenal failure or myasthenia gravis. 10. Patients with intestinal ileus, ulcerative colitis or Crohn´s disease. 11. Patients with suspected alcohol and/or drug addiction. 12. Patients with hypersensitivity or intolerance to the tested drugs or to other NSAIDs, salicylic acid, or opiates. 13. Patients receiving concomitant treatment or who have received treatment in the previous 48 hours, with any of the following drugs: Antiepileptics Methotrexate Antipsychotics Cylosporin MAOIs Lithium Oral anticoagulants Systemic steroids 14. Patients who had taken any NSAID or analgesic drug (excepting paracetamol) within twelve hours of surgery. 15. Patients receiving concomitant treatment with other investigational drugs or who had participated in another clinical trial two months before the inclusion in the study. 16. Nursing or pregnant women. A pregnancy test will be done to all fertile women and should be negative to include the patient in the study. 17. Patients unable to understand the nature of the study by any reason (culture, language comprehension, …) or whom the investigator suspects may not collaborate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the analgesic effect of dexketoprofen trometamol (50 mg t.i.d.) versus ketorolac (30 mg t.i.d.) and placebo, as part of a balanced analgesic therapy with morphine, in patients with postoperative pain after orthopaedic surgery, by means of the determination of total cumulative amount of morphine in the first 24 hours of treatment ;Secondary Objective: - To evaluate the analgesic effect by means of the pain intensity assessment in the first 48 hours of treatment (intravenous phase) - To evaluate the analgesic effect by means of the total cumulative amount of morphine in the first 48 hours of treatment (intravenous phase) - To evaluate the analgesic effect by means of the pain intensity assessment during the phase of oral treatment - To evaluate the quality of sleep in the first 48 hours of treatment (intravenous phase) - To evaluate the level of sedation in the first 48 hours of treatment (intravenous phase) - To assess the safety and tolerability of the treatments - The overall assessment of the treatment by the patient and investigator’s team at the end of the study, or when the patient is withdrawn ;Primary end point(s): Determination of total cumulative amount of morphine in the first 24 hours of treatment | — |
Countries
Spain
Outcome results
None listed