Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201805003252954 Date of Approval: 26/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Acute Childhood Poisoning: One year study in Assiut University children's Hospital
Official scientific title Acute Childhood Poisoning: One year study in Assiut University children's Hospital
Brief summary describing the background and objectives of the trial Acute poisoning in children is a problem ubiquitous in distribution and is an important paediatrics emergency. In a report published by the WHO, 13% of the total poisoning cases were reported among the paediatrics and adolescent age groups. The highest percentage of children admitted to the poison center (44.8%) was in the age group of 3-5 years. At this age, children usually gain motor independence and they go around actively exploring their environment. Therefore, children become highly mobile and able to get into dangerous situations quickly. Additionally, children at that age have well developed skills to locate and ingest liquids and solids, but are unable to discriminate rapidly between edible liquids and solids from toxic ones. Reported that the peak of accidental poisoning was seen in children between 2-5 years, with this problem spreading in the developing countries as these agents become more available. According to the children¿s propensity to eat everything, ingestion is the most common route of poisoning in children, accounting for approximately 77% of the cases. After ingestion, dermal, inhalation and ophthalmic involvements are considered to be the most common causes of poisoning in children with respective frequencies of about 7.5%, 6% and 5% .The study reported that poor maternal education, inadequate supervision of children, substance abuse, and mental illness in family members are risk factors that increase the incidence of poisoning in children. This study aimed to assess the characteristics, clinical management and outcome of children with acute intoxication due to drugs and chemicals seeking medical care at the Paediatrics Emergency Departments
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Childhood poisoning,Injury, Occupational Diseases, Poisoning,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/04/2018
Actual trial start date 01/04/2018
Anticipated date of last follow up 01/04/2019
Actual Last follow-up date 01/04/2019
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Scoring system for Even KM et al over a year over a year Classification of childhood poisoning over one year 30 Active-Treatment of Control Group
Experimental Group emesis and gastric lavage and activated charcoal every 8hrs for 3 days After taking full history, Clinical examination, Vital signs examination and systematic examination patient is classified according to the Scoring system for Even KM et al then examined for serum level of toxicity, complete blood picture, liver and renal functions then patient is subjected to emesis, gastric lavage and activated charcoal if needed with observation. 30
Experimental Group Alkaline dieresis and antidote and dialysis every 8hrs for 3 days After taking full history, Clinical examination, Vital signs examination and systematic examination patient is classified according to the Scoring system for Even KM et al then examined for serum level of toxicity, complete blood picture, liver and renal functions then patient is subjected to Alkaline diuresis, antidotes and dialysis if needed with observation 30 Active-Treatment of Control Group
Control Group prevention of childhood poisoning over a year over a year Keep all medications out of the reach of children, Store all medicines in their original containers, Remember that child resistant packaging and other safety devices are not child proof, never take medicine in front of a young child, never administer medicine to a child in the dark, dispose of all unneeded or outdated medicines as directed,Store all products in their original containers. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o Poisoned children as organophosphorus or scorpion or drug toxicity presented with: ¿ Hemodynamic stability. ¿ Presented with complications as: Coma, respiratory distress, cardiovascular instability (severe hypotension or cardiac arrhythmias), or any organ failure. ¿ Allergic reaction to food. 2 Year(s) 13 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/03/2018 Faculty of Medicine Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine-Assiut University Assiut 71111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the characteristics, clinical management and outcome of children with acute intoxication due to drugs and chemicals. Over a year
Secondary Outcome To differentiate between acute intoxication and allergic food reaction. Over a year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut University Pediatrics Hospital Assiut University Hospital Assiut 71111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Assiut University Pediatrics Hospital Assiut University Hospital Assiut 71111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Assiut University Pediatrics Hospital Assiut University Hospital Assiut 71111 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Assiut University Pediatrics Hospital Assiut University Hospital Assiut 71111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Azza Ahmed EL-Tayeb Ahmed Azza.eisa@med.au.edu.eg 01006863277 Assiut University Pediatrics Hospital
City Postal code Country Position/Affiliation
Assiut 71111 Egypt
Role Name Email Phone Street address
Public Enquiries mohamed kamal dr.mokamal86@gmail.com 01000270356 El Mobara health insurance Hospital
City Postal code Country Position/Affiliation
Assiut 170 Egypt Pediatrics residents
Role Name Email Phone Street address
Scientific Enquiries Faisal-ALKhateeb Ahmed Feisl.elkhateeb@med.au.edu.eg 01003858676 Assiut University Pediatrics Hospital
City Postal code Country Position/Affiliation
Assiut 71111 Egypt
REPORTING
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Changes to trial information