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A Comparative Study of Using Scorpion Antivenom Versus Scorpion Antivenom and Prazosin

Phase 4
Recruiting
Conditions
Morality
Interventions
Registration Number
NCT06287905
Lead Sponsor
Sohag University
Brief Summary

Interventional study designed for the evaluation of characters and the outcome of scorpion sting patients will admit to Sohag University Hospitals in 2 randomized groups. The first group will receive scorpion antivenom only whether by the intravenous or the intramuscular route of administration. The second group will receive a combination of prazosin plus scorpion antivenom whether by the intravenous or the intramuscular route of administration. Both groups will receive proper first aid and supportive treatment

Detailed Description

Tools of the study:

1. Dose and administration of prazosin: 30 μg/kg/dose of prazosin will be delivered orally every 6 hours 4 doses, in adults we shouldn't exceed 1 mg per dose. Prazosin will be delivered using a nasogastric tube while securing the patient's airway in the event of vomiting or unconsciousness. Every 30 minutes for the first three hours, every hour for the following six, and then every four hours until improvement, blood pressure, pulse rate, respiration rate, and oxygen saturation will be measured. When pain is the only symptom, prophylaxis shouldn't be given. To avoid the first-dose phenomenon, the patient should remain in a laying position for around 3 hours (even while the case is being examined) (Shoreit et al., 2019).

Dose of antivenom 1-1 ampoule intramuscular and/ or, 2-1 to 5 Polyvalent anti-scorpion serum ampoules produced by the vaccine \& serum institution (VACSERA)in Egypt according to the severity of the case on 200 to 500 ml glucose 5% infusion and assess the patient clinically to repeat the dose after 4 to 6 hours. (Shoreit et al., 2019)

2. A prepared sheet containing

1. the demographic characteristics of each patient

2. Vital signs and degree of coma at time of admission of the patient.

3. First aid management as resuscitation.

4. Supportive management will be done to the patients during the admission will be recorded.

5. Cardiac enzymes measurements, duration of hospital stay and the outcome of patients in each group.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
80
Inclusion Criteria

Not provided

Exclusion Criteria
  • .All other envenomation cases or poisoning will be excluded.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
group of adding prazosin plus standard treatmentPrazosin Oral Tablet1-Dose and administration of prazosin: 30 μg/kg/dose of prazosin will be delivered orally every 6 hours 4 doses, in adults we shouldn't exceed 1 mg per dose. Prazosin will be delivered using a nasogastric tube while securing the patient's airway in the event of vomiting or unconsciousness. Every 30 minutes for the first three hours, every hour for the following six, and then every four hours until improvement, blood pressure, pulse rate, respiration rate, and oxygen saturation will be measured. When pain is the only symptom, prophylaxis shouldn't be given. To avoid the first-dose phenomenon, the patient should remain in a laying position for around 3 hours (even while the case is being examined) (Shoreit et al., 2019).
Primary Outcome Measures
NameTimeMethod
Mortality"up to 1 month"

record the mortality rate in the two groups during the hospital stay

Secondary Outcome Measures
NameTimeMethod
Morbidity"through the study completion an average of a 1 year "

assess any complications with the patients in the two groups fever, allergy, hypotension

Trial Locations

Locations (1)

Meray Medhat Shokry Zaghary

🇪🇬

Sohag, Egypt

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