Compare Two Anti-Scorpion Venom Serum In Children

Study Overview
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Brief Summary
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The morbidity associated with scorpion sting intoxication presents an endemic pattern in the country, where there are highly venomous species of scorpions so the scorpion sting intoxication (IPPA) is considered a medical emergency. On the other hand, there is scarce scientific literature from different controlled studies evaluating anti-scorpion serum, considering clinical severity scales, lab results and their safety. The aim of this study is to compare the efficacy and safety of scorpion sting treatment, using two sera, one produced by Birmex versus Alacramyn ® (Bioclon).

Detailed Description
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We consider relevant conduct this study because the poisoning scorpion bite represents a public health problem. This is a randomized clinical trial, which included 120 subjects of both sexes aged 0 and 15 years old and residents of the state of Guanajuato, divided into 2 groups: 60 patients received antiscorpion serum of Birmex and 60 patients receive other commercial serum (Alacramyn).

Official Title
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Randomized Controlled Trial To Evaluate Efficacy And Safety Of The Polyvalent Anti-scorpion Venom Serum Of Birmex Versus Other Commercial Venom Serum In Children Population

Conditions
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Scorpion Sting

Intervention / Treatment
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* Biological: Anti-scorpion venom serum Birmex
* Biological: Anti-scorpion venom serum Alacramyn


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scorpion sting Either sex Age 1 to 15 years Signing an informed consent (signed by parent or guardian) Being residents of the state of Guanajuato Exclusion Criteria: Previous treatment with gamma globulin or immunoglobulin Blood transfusion at any stage of life Patients treated with drugs that interact with anti-scorpion serum History or history of sensitivity or intolerance to anti-scorpion serum or horse products Pregnancy Any immunodeficiency Patients who have participated in a research protocol in the previous month.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 15 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-scorpion venom serum Birmex<br>Patients 0 to 15 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex | Biological: Anti-scorpion venom serum Alacramyn<br>* The dose may be required fot the patient according to clinical manifestations and evolution<br>* Other names: antiscorpion venom serum;|
| Active Comparator: Anti-scorpion venom serum Alacramyn<br>Patients 0 to 15 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn) | Biological: Anti-scorpion venom serum Birmex<br>* the dose may be required for the patient according to clinical manifestations and evolution<br>* Other names: anti-scorpion venom serum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of signs and symptoms of scorpion envenomation |  | after treatment (expected average of 12 hrs) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the adverse events in every treated child |  | inmediately after treatment and until 5 days later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-Scorpion venom serum, venom, efficacy, safety, children