A phase II clinical trial to assess the safety of clonidine in acute organophosphorus pesticide poisoning

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dc.contributor.authorPerera, Polwattage MS
dc.contributor.authorJayamanna, Shaluka F
dc.contributor.authorHettiarachchi, Raja
dc.contributor.authorAbeysinghe, Chandana
dc.contributor.authorKarunatilake, Harindra
dc.contributor.authorDawson, Andrew H
dc.contributor.authorBuckley, Nicholas
dc.date.accessioned2016-01-12T22:43:06Z
dc.date.available2016-01-12T22:43:06Z
dc.date.issued2009-08-20
dc.date.updated2016-02-24T10:36:46Z
dc.description.abstractBACKGROUND An 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. METHODS This 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. RESULTS The 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. CONCLUSION Our 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.
dc.description.sponsorshipSACTRC is funded by the Wellcome Trust/National Health and Medical Research Council International Collaborative Research Grant GR071669MA.en_AU
dc.identifier.issn1745-6215en_AU
dc.identifier.urihttp://hdl.handle.net/1885/95358
dc.publisherBioMed Central
dc.rights© 2009 Perera et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
dc.sourceTrials
dc.subjectacute disease
dc.subjectadult
dc.subjectantidotes
dc.subjectclonidine
dc.subjectfemale
dc.subjecthumans
dc.subjectmale
dc.subjectmiddle aged
dc.subjectpesticides
dc.subjectorganophosphate poisoning
dc.titleA phase II clinical trial to assess the safety of clonidine in acute organophosphorus pesticide poisoning
dc.typeJournal article
local.bibliographicCitation.issue1en_AU
local.bibliographicCitation.startpage73en_AU
local.contributor.affiliationPerera, Polwattage MS, University of Peradeniya , Sri Lankaen_AU
local.contributor.affiliationJayamanne, Shaluka, University of Peradeniya, Sri Lankaen_AU
local.contributor.affiliationHettiarachchi, Raja, University of Peradeniya, Sri Lankaen_AU
local.contributor.affiliationAbeysinghe, Chandana, University of Peradeniya , Sri Lankaen_AU
local.contributor.affiliationKarunatilake, Harindra, University of Peradeniya , Sri Lankaen_AU
local.contributor.affiliationDawson, Andrew, College of Medicine, Biology and Environment, CMBE ANU Medical School, ANU Medical School, The Australian National Universityen_AU
local.contributor.affiliationBuckley, Nicholas, College of Medicine, Biology and Environment, CMBE ANU Medical School, ANU Medical School, The Australian National Universityen_AU
local.contributor.authoremailadawson@sactrc.orgen_AU
local.contributor.authoruidu4842276en_AU
local.description.notesImported from ARIESen_AU
local.identifier.absfor111506en_AU
local.identifier.ariespublicationu4133361xPUB297en_AU
local.identifier.citationvolume10en_AU
local.identifier.doi10.1186/1745-6215-10-73en_AU
local.identifier.essn1745-6215en_AU
local.identifier.scopusID2-s2.0-70350106721
local.identifier.uidSubmittedByu3488905en_AU
local.publisher.urlhttp://www.biomedcentral.com/en_AU
local.type.statusPublished Versionen_AU

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