Abstract
BackgroundAn estimated 2–3 million people are acutely poisoned by organophosphorus pesticides each year, mostly in the developing world. There is a pressing need for new affordable antidotes and clonidine has been shown to be effective in animal studies. Our aim was to determine the safety of clonidine given as an antidote in adult patients presenting with signs or symptoms of acute organophosphate ingestion.MethodsThis study was a dose finding, open-label, multicentre, phase II trial. Forty eight patients with acute organophosphate poisoning were randomized to receive either clonidine or placebo: Four to receive placebo and twelve to receive clonidine at each dose level. The first dose level was an initial loading dose of 0.15 mg followed by an infusion of 0.5 mg of clonidine over 24 hours. The initial loading dose was increased to 0.3 mg, 0.45 and 0.6 mg. at all dosing levels however the subsequent infusion remained at 0.5 mg of clonidine over 24 hours.ResultsThe baseline characteristics of both groups were similar. The trial was stopped after completion of the 3rd dosing level. At the 1st and 2nd dosing level there were no reported adverse drug reactions. At the 3rd dosing level 5 patients (42%) developed significant hypotension during clonidine treatment that responded to intravenous fluids. There were no statistical differences in ventilation rate, pre and post GCS, and mortality rates over all levels.ConclusionOur findings suggest use of moderate doses of clonidine in acute organophosphate poisoning can be used without causing frequent clinical problems but that higher doses are associated with a high incidence of hypotension requiring intervention. Further studies are needed to study the efficacy of clonidine as an antidote in organophosphate poisoning.Trial registrationCurrent Controlled Trial ISRCTN89917816.
Highlights
An estimated 2–3 million people are acutely poisoned by organophosphorus pesticides each year, mostly in the developing world
Anticholinesterase pesticides account for two thirds of these pesticide poisoning deaths and these are most common in rural areas of the developing world where the World Health Organization (WHO) estimates 2–3 million people are affected annually
At the 3rd dosing level, low blood pressure readings (
Summary
An estimated 2–3 million people are acutely poisoned by organophosphorus pesticides each year, mostly in the developing world. Each year at least 300,000 thousand people die from deliberate ingestion of pesticides [1] These deaths are responsible for about a third of the global burden of illness from suicide [2]. Poisoning in Sri Lanka is always among the five leading causes of mortality and morbidity and accounts for about 80,000 hospitalizations and 3000 deaths per year [4] This problem is compounded by the fact that approximately 35% of patients acutely poisoned with organophosphates require intensive care and mechanical ventilation [5]. This is despite conventional antidote treatment with atropine and pralidoxime [3]. Acetylcholinesterase inhibition leads to excessive accumulation of acetylcholine at nicotinic and muscarinic synapses leading to widespread clinical effects culminating in neuromuscular and respiratory failure
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