Comparison of Lysine Clonixinate, Ketorolac and Metamizole Sodium in Scorpion Stings

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Clinical Trial: Comparison of Lysine Clonixinate, Ketorolac and Metamizole Sodium in Poisoning by Scorpion Stings

Conditions
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Scorpion Stings, Pain, Analgesic

Intervention / Treatment
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* Diagnostic Test: Visual Analogue Scale for pain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of pain by scorpion stings Patients> 18 years old Clinical diagnosis of scorpion sting poisoning grade I, II and III. Chronic degenerative diseases (renal failure, hypertension, liver damage) Exclusion Criteria: Patients who reject the continuation of medical treatment Patients who are transferred to a unit of second level of care. Patients with pharmacological treatment prior

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metamizole sodium<br>1 gram intravenous, will be diluted in 0.9% physiological solution of 100 ml, applied for 30 minutes | Diagnostic Test: Visual Analogue Scale for pain<br>* Will be assessed at 0´, 30´, 60´, 90 minutes and 18 hours after the application of the analgesic.<br>|
| Active Comparator: Ketorolac<br>60 milligrams intravenously, it will be added to 20 ml with 0.9% physiological solution, it will be applied for 5 minutes | Diagnostic Test: Visual Analogue Scale for pain<br>* Will be assessed at 0´, 30´, 60´, 90 minutes and 18 hours after the application of the analgesic.<br>|
| Active Comparator: Lysine Clonixinate<br>100 milligram intravenously, diluted in 5% glucose solution of 100 ml, applied for 30 minutes | Diagnostic Test: Visual Analogue Scale for pain<br>* Will be assessed at 0´, 30´, 60´, 90 minutes and 18 hours after the application of the analgesic.<br>|
| Placebo Comparator: Placebo<br>20 milliliters of 0.9% physiological solution, will be applied for 5 minutes. | Diagnostic Test: Visual Analogue Scale for pain<br>* Will be assessed at 0´, 30´, 60´, 90 minutes and 18 hours after the application of the analgesic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |