drugset / Trial / NCT02160548

Adding Nebulized Salbutamol to Intravenous Atropine and Oxygen in OP Poisoning

NCT02160548

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-04
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Salbutamol Unknown 2.5 mg Other
Subject Salbutamol Unknown 5 mg Other
Comparator Atropine Other / unclassified Intravenous
Comparator Pralidoxime Small molecule Intravenous