Acute Pain
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Escócia association in adults with acute pain.
Interventions
DRUGEscócia association
Escócia association tablet
OTHERPlacebo Ketorolac
Placebo Ketorolac tablet
OTHERPlacebo Scopolamine
Placebo Scopolamine dragee
DRUGKetorolac Tromethamine
Ketorolac tablet
DRUGScopolamine
Scopolamine dragee
OTHERPlacebo Escócia association
Placebo Escócia association tablet
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed