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

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Butylscopolammonium Bromide; Ketorolac; Ketorolac Tromethamine; Scopolamine

Criteria

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.