Efficacy and Safety of Escócia Association in the Treatment of Acute Pain
Phase 2
Withdrawn
- Conditions
- Acute Pain
- Interventions
- Drug: Escócia associationOther: Placebo ScopolamineOther: Placebo KetorolacOther: Placebo Escócia association
- Registration Number
- NCT04666701
- Lead Sponsor
- EMS
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Escócia association in adults with acute pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Escócia association Escócia association The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows: 1 tablet Escócia association, oral 1 dragee Placebo Scopolamine, oral 1 tablet Placebo Ketorolac, sublingual Ketorolac Placebo Escócia association The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows: 1 tablet Ketorolac, sublingual 1 tablet Placebo Escócia association, oral 1 dragee Placebo Scopolamine, oral Escócia association Placebo Ketorolac The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows: 1 tablet Escócia association, oral 1 dragee Placebo Scopolamine, oral 1 tablet Placebo Ketorolac, sublingual Ketorolac Placebo Scopolamine The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows: 1 tablet Ketorolac, sublingual 1 tablet Placebo Escócia association, oral 1 dragee Placebo Scopolamine, oral Scopolamine Placebo Escócia association The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows: 1 dragee Scopolamine, oral 1 tablet Placebo Ketorolac, sublingual 1 tablet Placebo Escócia association, oral Ketorolac Ketorolac Tromethamine The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows: 1 tablet Ketorolac, sublingual 1 tablet Placebo Escócia association, oral 1 dragee Placebo Scopolamine, oral Escócia association Placebo Scopolamine The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows: 1 tablet Escócia association, oral 1 dragee Placebo Scopolamine, oral 1 tablet Placebo Ketorolac, sublingual Scopolamine Placebo Ketorolac The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows: 1 dragee Scopolamine, oral 1 tablet Placebo Ketorolac, sublingual 1 tablet Placebo Escócia association, oral Scopolamine Scopolamine The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for a maximum of 5 days, if pain, as follows: 1 dragee Scopolamine, oral 1 tablet Placebo Ketorolac, sublingual 1 tablet Placebo Escócia association, oral
- Primary Outcome Measures
Name Time Method Change from baseline in pain intensity 0-1 hour The change from baseline in pain intensity 1 hour after using the first dose of medication. Pain intensity will be assessed by visual analog scale (VAS), between 0 cm (no pain) and 10 cm (worst pain), recorded in the participant's diary.
- Secondary Outcome Measures
Name Time Method Incidence and severity of adverse events recorded during the study 10 days Incidence and severity of adverse events recorded during the study over 10 days.