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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 18 January 2016
Main ID:  NCT02160548
Date of registration: 07/06/2014
Prospective Registration: Yes
Primary sponsor: Sylhet M.A.G.Osmani Medical College
Public title: Adding Nebulized Salbutamol to Intravenous Atropine and Oxygen in OP Poisoning SalbutamolOP
Scientific title: Effect of Adding Nebulized Salbutamol to Intravenous Atropine and Oxygen During Resuscitation of OP Pesticide Poisoned Patients
Date of first enrolment: April 2015
Target sample size: 75
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02160548
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Bangladesh
Contacts
Name:     Fazle R Chowdhury, FCPS
Address: 
Telephone:
Email:
Affiliation:  Consultant, Medicine, Sylhet M.A.G.Osmani Medical Collge, Sylhet, Bangladesh
Name:     Michael Eddleston, PhD
Address: 
Telephone:
Email:
Affiliation:  Professor of Clinical Toxicology, University of Edinburgh
Key inclusion & exclusion criteria

Inclusion Criteria:

- age 12 yrs or older

- clinical features of OP poisoning

- requiring oxygen and atropine and give consent

Exclusion Criteria:

- age 11 yrs or younger

- no requirement for atropine



Age minimum: 12 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Organophosphate Poisoning
Intervention(s)
Drug: Standard care+ 2.5 mg Salbutamol
Drug: Standard care+ 5 mg Salbutamol
Drug: Standard care
Primary Outcome(s)
Improvement of oxygen saturation [Time Frame: 60 minutes]
Secondary Outcome(s)
Heart rate, respiratory rate and Blood pressure [Time Frame: 60 minutes]
Secondary ID(s)
Medicine SOMCH
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of Edinburgh
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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