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 pain

aboratorios Menarini, S.A0 sites0 target enrollmentOctober 14, 2004

Overview

No summary available.

Registry

who.int

Start Date

October 14, 2004

End Date

October 16, 2007

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

aboratorios Menarini, S.A

•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

•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.