Multicentre clinical trial to evaluate the efficacy and safety of dexketoprofen trometamol (50 mg t.i.d.) versus ketorolac (30 mg t.i.d.) and placebo by intravenous route, as part of balanced analgesic therapy with morphine, followed by an oral dosing, in the treatment of postoperative pai

Phase 1

• Conditions: elective orthopedic surgery (hip arthroplasty); MedDRA version: 7.0Level: PTClassification code 10020096

• Registration Number: EUCTR2004-001373-26-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: 2004-10-14
• Study Completion: 2007-10-16
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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

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:
AntiepilepticsMethotrexate
AntipsychoticsCylosporin
MAOIsLithium
Oral anticoagulantsSystemic 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.

Study & Design

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