Management and Outcome of Scorpion Sting in Children

September 24, 2024 updated by: Mahmoud Hamdy Abdelaziz Sayed, Assiut University
To determine the clinical characteristics of children with scorpion sting and implement guidelines for management of those children and observe the outcome

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Scorpion envenomation is a severe,sometimes fatal medical condition especially in children .Worldwide,there are more than 1.2 million scorpion stings each year,mostly in tropical and subtropical regions.Every year,more than 420,000 snake bite,scorpion sting and spider bite incidents occur in the Middle East and North Africa (MENA).In the region of Assiut,in the South of Egypt,the annual incidence and mortality by scorpion stings has been reported to be 88 and 5.5 per 100,000 inhabitants.There are 1500 sub species of scorpions in the globe,and 50 of those have venom that is harmful to humans.The most toxic scorpion families are the Buthidae family.The MENA region is home to 27 species of scorpions from three families:theButhidae,Hemiscorpiidae,and Scorpionidae.Significant morbidity and mortality are caused by scorpion stings .In addition to local effectslikeredness,pain,burning,and swelling,scorpion venom exhibits variability among sub species and has a complex structure made up of neurotoxic proteins,salts,acidic proteins,and organic compounds.These components can cause neurological,cardiovascular,hematologic,and renal side effects.Because scorpion venoms are complex mixtures of several toxins,including cardiotoxins,nephrotoxins,hemolytictoxins,and neurotoxins,there is a possible danger of developing severe and frequently deadly clinical consequences.Heart failure and pulmonary edema are the main causes of mortality .As regards management of scorpion sting early antivenom treatment is recommended but its value remains controversial as it may cause anaphylactic reactions .Furthermore the majority of cases need supportive treatment to alleviate the cardiovascular effect.Cardiovascular symptoms respond well to vasodilators such as alpha-1blockers like prazosin.Prazosinis considered a physiological and pharmacological antidote to scorpion venom action.It antagonizes the after-effects of venom-liberated catecholamines.Since the use of prazosin with antivenom the recovery from scorpion sting has been hastened and mortality rate has been reduced from 30% to 1%.Uptill now there are no guidlines implemented at our hospital for the management of scorpion sting so that our study will aim at implementing guidelines for management of children with scorpion sting and observe the outcome of those children.The guidelines used are those recommended from the Egyptian ministry of health and Population with the addition of prazosin as many studies have concluded the benefits of prazosin

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt, 088
        • Children hospital Assiut University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Prazosin will be given to all children with systemic manifestations (orally or by nasogastric tube) at a dose of 30 μg/kg/dose;first repeat dose at 3 h followed by every 6 h till recovery.

Description

Inclusion Criteria:

- All children under 18 years with definite history of scorpion sting

Exclusion Criteria:

  • Children with no definite history of sting or more than 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Role of prazosin in management of scorpion sting
Time Frame: Baseline

Prazosin, a post synaptic alpha blocker, can be recommended as an effective drug in the treatment of serious scorpion enve- nomations with significant sympathetic symptoms.antagonises the effects of catecholamines thereby preventing further damage of myocardium though it cannot reverse the damage

Prazosin will be given to all children with systemic manifestations (orally or by nasogastric tube) at a dose of 30 μg/kg/dose;first repeat dose at 3 h followed by every 6 h till recovery.To determine the clinical characteristics of children with scorpion sting and implement guidelines for management of those children and observe the outcome.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Management of scorpion sting

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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