A MULTICENTRE CLINICAL TRIAL EVALUATING THE ANALGESIC EFFICACY AND SAFETY OF DEXKETOPROFEN TROMETAMOL (50 mg i.v. FOLLOWED BY AN ORAL DOSAGE OF 25 mg t.i.d.) VERSUS METAMIZOL (2 g i.v. and 575 mg t.i.d. BY ORAL ROUTE) FOR THE TREATMENT OF PAIN SUBSEQUENT TO AMBULATORY MAJOR SURGERY

Phase 1

• Conditions: Patients who underwent ambulatory surgery consisting in unilateral inguinal mesh hernioplasty; MedDRA version: 7.0Level: LLTClassification code 10022025

• Registration Number: EUCTR2004-001789-42-ES
• Lead Sponsor: aboratorios Menarini, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-11-22
• Study Completion: 2007-01-23
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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

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 agentsOral 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified