Role of Steroids and Extended Scorpion Anti-Venom Use in Cardiac Affection Among Scorpion Stung Pediatric Cases

NCT06838715 | Not Yet Recruiting DMC

• 1 other identifier: Scorpion in Pediatrics
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Scorpion envenomation is considered a serious public health issue in the Middle East and Northern Sahara . According to the world health organization (WHO), around 1.2 to 1.5 million individuals are suspected to scorpion stings annually in Middle East; with 3000 to 5000 deaths rate .

Conditions

Scorpion Envenomation

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of steroids and anti-venom regimen

  80 of patients will take Treatment of the scorpion sting by using steroids and extended anti-venom regimen and assessing them after the treatment to see if they in need of intubation or ICU admission or hospital stay.

  7 days

Study Arms (4)

Group of non extended anti-venom:

ACTIVE COMPARATOR

About 20 Patients treated with classical non extended anti-venom regimen as 3-5 ampoules by injection and supportive measure only with evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting.

Drug: Dexamethasone

Group of Dexamethazone

ACTIVE COMPARATOR

About 20 Patients treated with Dexamethazone (The dose as: 0.2 mg/kg/day in week1, 0.15 mg/kg/day in week 2, 0.075 mg/kg/day in week) besides supportive measures with evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting.

Drug: Dexamethasone

Group of extended antivenom regimen

ACTIVE COMPARATOR

About 20 Patients treated with extended antivenom regimen as 3-5 ampoules by injection besides supportive measures with evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting.

Drug: Dexamethasone

Group of Dexamethazone and extended antivenom regimen

ACTIVE COMPARATOR

About 20 Patients treated with Dexamethazone (The dose as: 0.2 mg/kg/day in week1, 0.15 mg/kg/day in week 2, 0.075 mg/kg/day in week) and extended antivenom regimen as 3-5 ampoules by injection besides supportive measures with evaluation of cytokine evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting.

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Assessing the relation between the level of cytokines (interleukins and tumor necrosis factor alpha) and the development of cardiac complications associated with scorpion envenomation among pediatric patients. and Evaluating the role of the use of Dexamethasone and/or extended anti-venom administration on cardiac function and outcome in pediatric cases.

Also known as: Scorpion Anti Venom

Group of Dexamethazone; Group of Dexamethazone and extended antivenom regimen; Group of extended antivenom regimen; Group of non extended anti-venom:

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- Patients with scorpion stings and diagnosed as grade 1, 2 \& 3 (according to recent history of scorpion sting and clinical presentation at the time of admission) .

You may not qualify if:

• Patients with history of cardiac disease, OR previous cardiac operation and or previous abnormal cardiac investigations .
• Patients with history of chronic renal, hepatic, chest or CNS diseases .
• Patients with chronic inflammatory diseases such as auto-immune diseases, with chronic use of corticosteroids .
• Envenomated cases that are described as grade 4 scorpion envenomation.
• Cases of scorpion sting above age of 18 years.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Pediatric Hospital

Asyut, Egypt

Location

Related Publications (1)

• Abroug F, Ouanes-Besbes L, Tilouche N, Elatrous S. Scorpion envenomation: state of the art. Intensive Care Med. 2020 Mar;46(3):401-410. doi: 10.1007/s00134-020-05924-8. Epub 2020 Mar 3.

  PMID: 32125457 RESULT

MeSH Terms

Conditions

Scorpion Stings

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Marwa Khalifa Mohamed, lecturer

  Assiut University

  STUDY DIRECTOR

• Nagwa Mahmoud Ali, professor

  Assiut University

  STUDY CHAIR

• Hala Mohamed Fathi, professor

  Assiut University

  STUDY CHAIR

Central Study Contacts

yousef Ahmed Yousef, M.D

CONTACT

01020098463; youssif_hassan@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatrics

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: February 21, 2025
• Study Start: May 1, 2025
• Primary Completion: April 25, 2026
• Study Completion: May 1, 2026
• Last Updated: February 21, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)