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| Name | Class |
|---|---|
| Instituto Bioclon S.A. de C.V. | INDUSTRY |
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The cases of scorpion stings are matters of medical importance, where Mexico is considered as one of the main countries of such public health problem.
The states with the highest incidence of cases in 2018 were Jalisco with 47370 bite reports, Guerrero with 40672 cases and Guanajuato with 40331, according to the national epidemiological surveillance system.
Due to the high affinity on ion channels, where a cystine inhibitor BmP01, it is directed to the nociceptive ion channel TRPV1 to produce pain.Pain has been reported to occur in approximately 97% of patients They are seen in the emergency room.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metamizole sodium | Active Comparator | 1 gram intravenous, will be diluted in 0.9% physiological solution of 100 ml, applied for 30 minutes |
|
| Ketorolac | Active Comparator | 60 milligrams intravenously, it will be added to 20 ml with 0.9% physiological solution, it will be applied for 5 minutes |
|
| Lysine Clonixinate | Active Comparator | 100 milligram intravenously, diluted in 5% glucose solution of 100 ml, applied for 30 minutes |
|
| Placebo | Placebo Comparator | 20 milliliters of 0.9% physiological solution, will be applied for 5 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual Analogue Scale for pain | Diagnostic Test | Will be assessed at 0´, 30´, 60´, 90 minutes and 18 hours after the application of the analgesic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of antivenom as a pain treatment by the visual analogue scale of pain in poisoning by scorpion stings. | Comparison of venom metabolism in patients valued at 18 hours with Visual Analog Scales (VAS) valued from 0 to 10 | 18 hours after drugs in study |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the analgesic efficacy of clonixinate of lysine, ketorolac and sodium metamizol, by the visual analogue scale of pain in poisoning by scorpion stings. | Comparison of the effectiveness inter group over the pain by scorpion sting by Visual Analog Scales (VAS) valued from 0 to 10 | 0, 30, 60 and 90 minutes after administered the drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfredo Luis H Chávez Haro | Investigator | Study Director |
| Josue Saul H Almaraz | Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cruz Roja Mexicana, Delegación León | León | Guanajuato | 37179 | Mexico |
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| ID | Term |
|---|---|
| D065008 | Scorpion Stings |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001733 | Bites and Stings |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D010147 | Pain Measurement |
| ID | Term |
|---|---|
| D009460 | Neurologic Examination |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |