Patients who underwent ambulatory surgery consisting in unilateral inguinal mesh hernioplasty MedDRA version: 7.0 Level: LLT Classification code 10022025
Conditions
Interventions
Trade Name: Enantyum
Pharmaceutical Form: Tablet
INN or Proposed INN: Dexketoprofeno trometamol
CAS Number: 156604-79-4
Other descriptive name: DKP.TRIS
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Laboratorios Menarini, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between18 and 65 years old (both inclusive). 2. Grade I or II ASA physical status (American Society of Anaesthesiologists Scale). 3. Patients scheduled to undergo ambulatory major surgery consisting in non-relapsed unilateral inguinal mesh hernioplasty with intradural anaesthesia. 4. Patients who are able to understand the patient information sheet and who have provided 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Chronic treatment with opiates and/or NSAIDs. 2. Systemic or local surgical wound infection prior to the surgical procedure 3. History of peptic ulcer, NSAID-related gastropathy or gastrointestinal bleeding 4. Hypersensitivity or intolerance to acetylsalicylic acid, dexketoprofen, metamizol or other NSAIDs 5. Asthmatic patients or patients with history of bronchospasm, angioedema or nasal polyps 6. Patients with severe renal or hepatic failure 7. Patients with non-controlled diabetes, heart failure or hypertension 8. Blood coagulation disorders 9. Patients with any currently treated psychiatric disorder, such as endogenous depression, psychotic condition and/or bipolar disorder 10. Patients with Crohn’s disease, ulcerous colitis, acute intermittent porphyria or glucose-6-phosphate-dehydrogenase birth deficiency. 11. Patients receiving concomitant treatment or who have received treatment within 4 days prior to the surgical intervention with: Oral glycaemia lowering agents Oral anticoagulants Antiepileptic agents Methotrexate Tricyclic antidepressants Cyclosporine Antipsychotic agents Lithium 12. Clinically significant abnormalities on requested complementary pre-operative examinations 13. Suspected alcohol or drug abuse. 14. Inability to understand the nature of the study or to collaborate in its conduct 15. Patients receiving concomitant treatment with other investigational drugs or who have participated in another clinical trial within two months prior to study entry 16. Pregnant or breastfeeding women. A pregnancy test will be performed to all women of childbearing potential, who must have a negative result to be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the analgesic effects of dexketoprofen trometamol (50 mg i.v.) versus metamizol (2 g i.v.) in the immediate post-operative period (first 4 hours after intravenous route administration) in patients subsequent to ambulatory major surgery, through the assessment of pain intensity using visual analogue and verbal rating scales.;Secondary Objective: To evaluate: a) Need of rescue medication during the intravenous phase b) Analgesic efficacy of both drugs during the oral phase, through the assessment of pain intensity using visual analogue and verbal rating scales, and the assessment of pain relief using a verbal rating scale c) Need of rescue medication during the oral phase d) Quality of sleep using a verbal rating scale e) Overall efficacy assessment at end of treatment using a verbal rating scale f) Safety of both treatments ;Primary end point(s): Evaluation of the analgesic efficacy by the comparison of pain intensity (PI) mean scores obtained in the visual analogue scale (VAS) and the verbal rating scale during the intravenous phase (first 4 hours after the administration of the first (intravenous) dose). | — |
Countries
Spain
Outcome results
None listed