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Adding Nebulized Salbutamol to Intravenous Atropine and Oxygen in OP Poisoning

NCT02160548 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2015-12-29

No results posted yet for this study

Summary

We hypothesize that salbutamol will speed removal of alveolar fluid compared to atropine alone in OP poisoned patients. We propose to compare the effect of two stat doses of nebulized salbutamol (2.5 mg; 5.0 mg), with nebulized saline placebo, in symptomatic patients receiving standard resuscitation with atropine, oxygen, and fluids after poisoning with OP pesticides. 25 patients will be randomised to each arm (total 75 patients). Primary outcome will be oxygen saturation's over the following 60 min during resuscitation. Secondary outcomes will include atropine dose administered, speed to stabilization, aspiration or pneumonia, intubation, tachydysrhythmias, and mortality. A positive outcome will result in design of a large definitive phase III study.

Conditions

  • Organophosphate Poisoning

Interventions

DRUG

Standard care

Standard management for OP poisoning

DRUG

Standard care+ 2.5 mg Salbutamol

Ventolin respiratory solution 2.5 mg

DRUG

Standard care+ 5 mg Salbutamol

Ventolin respiratory solution 5 mg

Sponsors & Collaborators

  • University of Edinburgh

    collaborator OTHER

  • Sylhet M.A.G.Osmani Medical College

    lead OTHER

Principal Investigators

  • Fazle R Chowdhury, FCPS · Consultant, Medicine, Sylhet M.A.G.Osmani Medical Collge, Sylhet, Bangladesh

  • Michael Eddleston, PhD · Professor of Clinical Toxicology, University of Edinburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02160548 on ClinicalTrials.gov