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

NCT06287905 | Recruiting Phase 4 DMC

• 1 other identifier: Soh-Med-23-02-24
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Morality

Keywords

mortality, scorpion, antivenom, prazosin

Outcome Measures

Primary Outcomes (1)

• Mortality

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

  "up to 1 month"

Secondary Outcomes (1)

• Morbidity

  "through the study completion an average of a 1 year "

Study Arms (2)

group of antivenom only

NO INTERVENTION

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)

group of adding prazosin plus standard treatment

EXPERIMENTAL

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).

Drug: Prazosin Oral Tablet

Interventions

Prazosin Oral Tablet DRUG

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).

group of adding prazosin plus standard treatment

Eligibility Criteria

• Age: 1 Year - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• All other envenomation cases or poisoning will be excluded.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Meray Medhat Shokry Zaghary

Sohag, 82515, Egypt

RECRUITING

MeSH Terms

Interventions

Prazosin

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Meray M Shokry Zaghary

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meray M Shokry Zaghary, PhD

CONTACT

+201028911003; drevanho2013@gmail.com

Mai M Abd El Kader, PhD

CONTACT

+201028911003

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Simple randomization
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of clinical toxicology

Model Details: observational comparative

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 1, 2024
• Study Start: February 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)