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.: PACTR202101718826859 Date of Approval: 21/01/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role of diazepam in treatment of organophosphorus pesticides poisoning
Official scientific title Role of diazepam in treatment of organophosphorus pesticides poisoning: A randomized controlled trial
Brief summary describing the background and objectives of the trial the study was held to evaluate role of diazepam in organophosphorus pesticides poisoning and possible preventive effect against neurological complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2017
Actual trial start date 01/04/2017
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date 31/03/2019
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Completed
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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Diazepam 10 mg intravenous single dose patients in the experimental group received Diazepam intravenously after initial stabilization of patient (using atropine and obidoxime) in a single dose of 10 mg over 3 minutes. 50
Control Group saline single dose 5 ml saline once Intravenous saline after initial stabilization of patient using atropine and obidoxime in a single dose of 10 ml over 3 minutes. 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Symptomatic patients Exposd to organophosphorus pesticides > 18 years old Pregnant and lactating patients. Patients <18 years old. Patients who developed seizures after organophosphate poisoning. Patients with mixed ingestions. Epileptic patients or Patients with other neurological disorders. Patients with other serious medical conditions (e.g. cardiovascular disease, renal or hepatic failure). Patients who received treatment before admission Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 78 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 26/11/2014 Research Ethics committee Faculty of Medicine Tanta university
Ethics Committee Address
Street address City Postal code Country
Elgeish Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality, neurological comlpicatons any
Secondary Outcome The total dose of atropine required. Seizures: occurrence, response to treatment Electroencephalograph findings. Duration of hospital stay for live discharges. Need for mechanical ventilation. Intermediate syndrome any
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta Poison Control Center El Geish street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Manar Maher Ali Fayed Elinbabi street from Saed street Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MANAR Maher Ali Fayed El inbabi street with Saed street Tanta 31512 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Eman Mostafa Soliman Elgeish street Tanta 31527 Egypt
Arwa Abuelfadl Elgeish street Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Manar Fayed manar.fayed@med.tanta.edu.eg +201118566443 Elinbabi street with Saed street
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Depatrment of Forensic Medicin and Clinical Toxicology Faculty of Medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Eman Soliman dr.emansoliman1960@gmail.com +201005621611 Moheb street
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Department of Forensic Medicine and Clinical Toxicology Faculty of Medicine Tanta University
Role Name Email Phone Street address
Scientific Enquiries Manar Fayed manar.fayed@med.tanta.edu.eg +201118566443 Elinbabi street with Saed street
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Department of Forensic Medicine and Clinical Toxicology Faculty of Medicine Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes, I agree to share the recorded data of patients included in the trial Study Protocol one year Symptomatic adult patients exposed to organophosphorus pesticides admitted at Tanta poison control center Tanta University hospital.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 21/01/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information