Efficacy and Safety of Escócia Association in the Treatment of Acute Pain

National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Escócia Association in the Treatment of Acute Pain

The purpose of this study is to evaluate the efficacy and safety of Escócia association in adults with acute pain.

Inclusion Criteria:

• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
• Participants, aged 18 years and older, with renal colic admitted in the emergency service, or those who underwent an extracorporeal lithotripsy procedure to eliminate kidney stones.

Exclusion Criteria:

• Known hypersensitivity to the formula components used during the clinical trial;
• History of alcohol and/or substance abuse within 2 years;
• Pregnant women, breastfeeding or planning to become pregnant, or women with the potential to become pregnant who are not using a reliable method of contraception;
• Participants weighing less than 50 kg;
• Participants with suspected other causes of acute abdominal pain;
• Participants with a known history of peptic ulcer, gastrointestinal bleeding, perforation or inflammatory bowel disease;
• Participants with hypovolemia or dehydration;
• Renal failure, defined by the estimated glomerular filtration rate [eGFR] <60 mL / min / 1.73 m2;
• Participants with a known medical history of cerebrovascular bleeding, hemorrhagic diathesis (hemophilia), blood clotting disorders; postoperative of coronary artery bypass graft surgery, or using anticoagulants, including low heparin dose (2500-5000 units every 12 hours);
• Participants in the postoperative period with a high risk of bleeding or incomplete homeostasis;
• Participants with cardiovascular disease, chronic heart failure or with increased risk of cardiovascular events are at the discretion of the investigator, in order to include the participant;
• Participants with a current medical history of cancer and / or cancer treatment in the last 5 years;
• Participants using pentoxifylline, probenecid or lithium salts;
• Participants with megacolon and / or paralytic or obstructive ileus;
• Participants with glaucoma and myasthenia gravis;
• Participants on treatment with MAO inhibitors, or participants who have been treated with these drugs within 14 days;
• Participants on epilepsy not adequately controlled treatment.