Phase III clinical trial of superiority, randomized, multicentre, blind, parallel, to evaluate the efficacy and safety of Lisador® (Cosmed) compared to Novalgina® 500mg (Sanofi-Medley) in the treatment of postoperative pain in abdominal-pelvic videolaparoscopy

Brainfarma Indústria Química e Farmacêutica S.A.0 个研究点开始时间: 2019年2月4日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Sign the TCLE;
•-Men and women, aged 18 or over;
•-To present pain evaluation by the pain intensity scale: from 3,0 to 7,9 cm;
•- Having undergone elective surgery by abdominal-pelvic videolaparoscopy, not due to malignancy;
•- Schedule to be discharged within 24 hours of the end of the surgical procedure;

•Presence of infection associated with the condition, except for appendectomy;
•Surgery with indication for treatment of confirmed or suspected malignancy;
•Laparoscopic surgery that required conversion to open surgery;
•Use of opioids in the last 8 hours of signing the informed consent form;
•Chronic use of painkillers regularly for other reasons;
•Use of corticosteroids;
•Chronic use of any non-steroidal anti-inflammatory;
•Use of immunosuppressive therapy;
•Participants with a vomiting condition present at the time of signing the informed consent form;
•Presence of decompensated diabetes mellitus;
•History of decompensated obstructive or restrictive respiratory disease;
•History of blood dyscrasia or chronic disease of any nature that contraindicates the participation of the participant at the discretion of the investigator;
•Inability to understand and perform pain assessments in the study;
•Hypersensitivity or contraindication for use of the studied medication components;
•Morbid obesity;
•Pregnant women;
•Present one or more flu-like symptoms such as: fever, cough, dyspnoea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 14 days prior to the screening visit;
•Participation in another clinical study in less than 1 year.

发起方

Brainfarma Indústria Química e Farmacêutica S.A.