Centruroides Envenomation
Conditions
Keywords
Centruroides, Antivenom, Scorpion antivenom, Scorpion envenomation
Brief summary
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.
Interventions
DRUGTraditional scorpion antivenom regimen
All patients will be classified according to two severity scales. The pharmacist, who is the only team member aware of which group each patient was assigned to, will consider the classification corresponding to the classification proposed by the Mexican Clinical Practice Guideline to decide the dose of scorpion antivenom. Scorpion antivenom will be administered to all patients. Patients in this group will receive between one and three vials every 30 minutes, depending on the severity of the condition (one vial for patients classified as grade I, two vials for patients classified as grade II, and three vials for patients classified as grade III)
DRUGSerial dose of scorpion antivenom regimen
All patients will be classified according to two severity scales. The pharmacist, who is the only team member aware of which group each patient was assigned to, will consider the classification corresponding to the American classification to decide the dose of scorpion antivenom. Scorpion antivenom will be administered only in the presence of signs and/or systemic symptoms of intoxication, excluding signs and symptoms at the sting site. Patients in this group will receive between one and two vials every 30 minutes, depending on the severity of the condition (one vial for patients classified as grade III and two vials for patients classified as grade IV)
Sponsors
Selene Guadalupe Huerta Olvera
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A pharmacist will be responsible for randomizing the patients and preparing the study medication in a blinded manner, so that the treatment is administered by the physician without the care provider or the participant being able to identify it. The pharmacist will keep the randomization results in a sealed envelope that will be opened at the end of the study.
Intervention model description
Experimental Group: Patients with scorpion envenomation of any grade will receive scorpion antivenom therapy in a reduced regimen. The dosing regimen based on response will be one initial intravenous vial in patients with grade III scorpion envenomation, and two initial intravenous vials as the starting dose in patients with grade IV scorpion envenomation, according to the FDA classification of scorpion envenomation. In both scenarios, an additional vial can be administered every 30 minutes if symptoms persist, with no limit on vials. Control Group: Patients with scorpion envenomation of any grade will receive scorpion antivenom therapy according to the traditional regimen proposed in the Mexican Clinical Practice Guideline, where, according to the severity classification of scorpion envenomation, between one and six vials of anti-scorpion venom will be administered, and equal doses can be repeated every 30 minutes if necessary.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum venom concentration | two and a half to five hours | Serum venom concentration upon patient arrival, after administration of antivenom, and upon reporting the absence of signs of intoxication |
| Time to resolution of signs and symptoms | two and a half to five hours | Time to resolution of signs and symptoms from admission and from the estimated time of the sting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | two and a half to five hours | Mortality rate of each group |
| Length of intrahospital stay | two and a half to five hours | Time from patient admission to discharge due to patient improvement |
| Serum antivenom concentration | two and a half to five hours | Scorpion antivenom concentration at five minutes after administration, prior to secondary doses, and prior to discharge |
Countries
Mexico
Outcome results
None listed