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

Morality Clinical Trial

Official title:

A Comparative Study of Using Scorpion Antivenom Versus Scorpion Antivenom and Prazosin Drug for Scorpion Stings Management in Sohag University Hospitals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06287905
• Other study ID #: Soh-Med-23-02-24
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: Sohag University
• Contact: Meray M Shokry Zaghary, PhD
• Phone: +201028911003
• Email: drevanho2013[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 70 Years

Eligibility

Inclusion criteria:

• History and clinical diagnosis of scorpion sting

• Admit in Sohag University hospitals

• During the period from February 2023 to July 2024.

• Accepting informed written consent from the case itself or the first degree relative if the case will underage or in a coma.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Morality

Intervention

Drug:
• Prazosin Oral Tablet
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).

Locations

Country	Name	City	State
Egypt	Meray Medhat Shokry Zaghary	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	record the mortality rate in the two groups during the hospital stay	"up to 1 month"
Secondary	Morbidity	assess any complications with the patients in the two groups fever, allergy, hypotension	"through the study completion an average of a 1 year "