Scorpion StingsNCT06615440
Management and Outcome of Scorpion Sting in Children
An observational study of Scorpion Stings, run by Assiut University at 1 site in Egypt.
Trial summary
To determine the clinical characteristics of children with scorpion sting and implement guidelines for management of those children and observe the outcome Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Scorpion Stings
- What is being tested?
- Alpha blocker
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2024to Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- All children under 18 years with definite history of scorpion sting
Who cannot join
- Children with no definite history of sting or more than 18 years
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Children hospital Assiut University
Asyut, 088
Ghada Elsedfy, Prof, 01111985154, gelsedfy@aun.edu.eg
About this study
To determine the clinical characteristics of children with scorpion sting and implement guidelines for management of those children and observe the outcome
Read the 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
- Conditions
- Scorpion Stings
- Being tested
- Alpha blocker
- Medical subject headings
- Scorpion Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha blockerDrug
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. All patients will be monitored for clinical improvement with vital signs
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of prazosin in management of scorpion sting
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study startNov 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Scorpion StingsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hamdy Abdelaziz Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615440
- Sponsor's protocol ID
- Management of scorpion sting
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
WorldHealthOrganization.WHOExpertCommitteeonBiologicalStandardization, sixty-seventhreport.Licence:CCBY-NC-SA3.0IGO.Geneva;2017.Available: https://www.who.int/publications/i/item/9789241210133
Rajniti Prasad et al. Indian J Pediatr. 2011 May.https://link.springer.com/article/10.1007/s12098-010-0265-0
Kumar,Rakesh.AnupdateonepidemiologyandmanagementpracticesofScorpio nenvenomationinIndia.*JournalofFamilyMedicineandPrimaryCare*.11(9),493 2- 4935,September2022.DOI:10.4103/jfmpc.jfmpc_2300_2
Mohamad IL, Elsayh KI, Mohammad HA, Saad K, Zahran AM, Abdallah AM, Tawfeek MS, Monazea EM. Clinical characteristics and outcome of children stung by scorpion. Eur J Pediatr. 2014 Jun;173(6):815-8. doi: 10.1007/s00431-013-2244-8. Epub 2014 Jan 3.
PubMed 24384790FarghalyWM,AliFA(1999)Aclinicalandneurophysiologicalstudyofscorpion envenomationinAssiut,UpperEgypt.ActaPaediatr88(3):290-294.
Bawaskar HS, Bawaskar PH. Clinical profile of severe scorpion envenomation in children at rural setting. Indian Pediatr. 2003 Nov;40(11):1072-5.
PubMed 14660839https://scholar.google.com/scholar_lookup?journal=Int.+J.+Bioinform.+Biomed.+Eng.&title=Scorpion+sting+in+different+regions+of+Sudan:+epidemiological+and+clinical+survey+among+university+students&author=N.+Ali&author=N.+O+M+Ali&publication_year=2015&
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management and Outcome of Scorpion Sting in Children
- ClinicalTrials.gov ID
- NCT06615440
- Acronym / sponsor ID
- Management of scorpion sting
- Conditions
- Scorpion Stings
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the clinical characteristics of children with scorpion sting and implement guidelines for management of those children and observe the outcome
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- All children under 18 years with definite history of scorpion sting
Key exclusion criteria (1 listed)
- Children with no definite history of sting or more than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha blockerprazosin 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. All patients will be monitored for clinical improvement with vital signs | Drug | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Results publicationWorldHealthOrganization.WHOExpertCommitteeonBiologicalStandardization, sixty-seventhreport.Licence:CCBY-NC-SA3.0IGO.Geneva;2017.Available: https://www.who.int/publications/i/item/9789241210133
- Results publicationRajniti Prasad et al. Indian J Pediatr. 2011 May.https://link.springer.com/article/10.1007/s12098-010-0265-0
- Results publicationKumar,Rakesh.AnupdateonepidemiologyandmanagementpracticesofScorpio nenvenomationinIndia.*JournalofFamilyMedicineandPrimaryCare*.11(9),493 2- 4935,September2022.DOI:10.4103/jfmpc.jfmpc_2300_2
- Results publication: PubMed 24384790Mohamad IL, Elsayh KI, Mohammad HA, Saad K, Zahran AM, Abdallah AM, Tawfeek MS, Monazea EM. Clinical characteristics and outcome of children stung by scorpion. Eur J Pediatr. 2014 Jun;173(6):815-8. doi: 10.1007/s00431-013-2244-8. Epub 2014 Jan 3.
- Results publicationFarghalyWM,AliFA(1999)Aclinicalandneurophysiologicalstudyofscorpion envenomationinAssiut,UpperEgypt.ActaPaediatr88(3):290-294.
- Results publication: PubMed 14660839Bawaskar HS, Bawaskar PH. Clinical profile of severe scorpion envenomation in children at rural setting. Indian Pediatr. 2003 Nov;40(11):1072-5.
- Results publicationhttps://scholar.google.com/scholar_lookup?journal=Int.+J.+Bioinform.+Biomed.+Eng.&title=Scorpion+sting+in+different+regions+of+Sudan:+epidemiological+and+clinical+survey+among+university+students&author=N.+Ali&author=N.+O+M+Ali&publication_year=2015&
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scorpion Stings, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Mahmoudhamdi (+201002033862, mahmoudhamdi1177@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of prazosin in management of scorpion sting (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06615440, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.