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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06287905
Enrollment
80
Registered
2024-03-01
Start date
2023-02-01
Completion date
2024-07-01
Last updated
2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morality

Keywords

mortality, scorpion, antivenom, prazosin

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.

Interventions

DRUGPrazosin 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).

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Simple randomization

Intervention model description

observational comparative

Eligibility

Sex/Gender
ALL
Age
1 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mortalityup to 1 monthrecord the mortality rate in the two groups during the hospital stay

Secondary

MeasureTime frameDescription
Morbiditythrough the study completion an average of a 1 year assess any complications with the patients in the two groups fever, allergy, hypotension

Countries

Egypt

Contacts

Primary ContactMeray M Shokry Zaghary, PhD
drevanho2013@gmail.com+201028911003
Backup ContactMai M Abd El Kader, PhD
+201028911003

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026