Assessment of the Efficacy of Scorpion Antivenom Therapy in a Dose-response Manner, in Patients With Scorpionism

Selene Guadalupe Huerta Olvera

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Centruroides Envenomation

Treatments: Drug: Serial dose of scorpion antivenom regimen; Drug: Traditional scorpion antivenom regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT06333834

Dosis Seriada de Alacramyn

Details and patient eligibility

About

The clinical study aims to compare the effectiveness of applying two different regimens of scorpion antivenom therapy. In the first regimen (control), the medication is administered to all patients, and depending on the severity of the condition, the dosage varies. In the experimental regimen, an identical dose of scorpion antivenom is administered to patients exhibiting signs and symptoms of scorpion sting intoxication, in addition to pain and other symptoms at the sting site. The primary response variable is the time taken for signs and symptoms to resolve, but differences in complications, adverse effects, venom and antivenom concentration in the blood, and the need for other therapeutic measures are also evaluated.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals aged 18 or older presenting with a diagnosis of scorpionism to the emergency department.
• Treated solely with paracetamol, scorpion antivenom, saline solution, and local ice application.
• Any gender.
• Less than two hours elapsed since scorpion sting.
• Willing to participate in the study through written informed consent.

Exclusion criteria

• Allergies or contraindications to any of the study medications.
• Uncertainty regarding scorpion sting.
• Previous treatment by another physician.
• Intramuscular administration of scorpion antivenom due to urgent clinical conditions.
• Decision not to provide informed consent.
• Any limitations hindering the proper understanding of study participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Traditional scorpion antivenom regimen

Active Comparator group

Description:

Active/placebo comparator

Treatment:

Drug: Traditional scorpion antivenom regimen

Serial dose of scorpion antivenom regimen

Experimental group

Treatment:

Drug: Serial dose of scorpion antivenom regimen