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Article: Prospective observational study of adverse drug reactions to diclofenac in children

TitleProspective observational study of adverse drug reactions to diclofenac in children
Authors
Issue Date2009
PublisherBlackwell Publishing Ltd. The Journal's web site is located at http://www.blackwellpublishing.com/journals/BJCP
Citation
British Journal Of Clinical Pharmacology, 2009, v. 68 n. 2, p. 243-251 How to Cite?
AbstractWHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Diclofenac is frequently used off-label in children for acute pain, but little information is available on diclofenac adverse drug reactions in this population. WHAT THIS STUDY ADDS • The common adverse drug reactions of diclofenac for acute pain in children are of a similar type to those seen in adults. • Serious adverse reactions occur in <0.8% of children and the incidence of diclofenac-induced bronchospasm in asthmatic children is <2.7%. AIM The aim of this study was to investigate the type of common (occurring in >1% of patients) adverse reactions caused by diclofenac when given to children for acute pain. METHODS A prospective observational study was undertaken on paediatric surgical patents aged ≤12 years at Great Ormond Street and University College London Hospitals. All adverse events were recorded, and causality assessment used to judge the likelihood of them being due to diclofenac. Prospective recruitment meant not all patients were prescribed diclofenac, allowing an analysis of utilization. Causality of all serious adverse events was reviewed by an expert panel. RESULTS Children prescribed diclofenac were significantly older, and stayed in hospital for shorter periods than those who were not. Diclofenac was not avoided in asthmatic patients. Data on 380 children showed they suffer similar types of nonserious adverse reactions to adults. The incidence (95% confidence interval) of rash was 0.8% (0.016, 2.3); minor central nervous system disturbance 0.5% (0.06, 1.9); rectal irritation with suppositories 0.3% (0.009, 1.9); and diarrhoea 0.3% (0.007, 1.5). No serious adverse event was judged to be caused by diclofenac, meaning the incidence of serious adverse reactions to diclofenac in children is <0.8%. CONCLUSION Children given diclofenac for acute pain appeared to suffer similar types of adverse reactions to adults; the incidence of serious adverse reaction is <0.8%. © 2009 The British Pharmacological Society.
Persistent Identifierhttp://hdl.handle.net/10722/171384
ISSN
2015 Impact Factor: 3.83
2015 SCImago Journal Rankings: 1.486
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorStanding, JFen_US
dc.contributor.authorOoi, Ken_US
dc.contributor.authorKeady, Sen_US
dc.contributor.authorHoward, RFen_US
dc.contributor.authorSavage, Ien_US
dc.contributor.authorWong, ICKen_US
dc.date.accessioned2012-10-30T06:13:46Z-
dc.date.available2012-10-30T06:13:46Z-
dc.date.issued2009en_US
dc.identifier.citationBritish Journal Of Clinical Pharmacology, 2009, v. 68 n. 2, p. 243-251en_US
dc.identifier.issn0306-5251en_US
dc.identifier.urihttp://hdl.handle.net/10722/171384-
dc.description.abstractWHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Diclofenac is frequently used off-label in children for acute pain, but little information is available on diclofenac adverse drug reactions in this population. WHAT THIS STUDY ADDS • The common adverse drug reactions of diclofenac for acute pain in children are of a similar type to those seen in adults. • Serious adverse reactions occur in <0.8% of children and the incidence of diclofenac-induced bronchospasm in asthmatic children is <2.7%. AIM The aim of this study was to investigate the type of common (occurring in >1% of patients) adverse reactions caused by diclofenac when given to children for acute pain. METHODS A prospective observational study was undertaken on paediatric surgical patents aged ≤12 years at Great Ormond Street and University College London Hospitals. All adverse events were recorded, and causality assessment used to judge the likelihood of them being due to diclofenac. Prospective recruitment meant not all patients were prescribed diclofenac, allowing an analysis of utilization. Causality of all serious adverse events was reviewed by an expert panel. RESULTS Children prescribed diclofenac were significantly older, and stayed in hospital for shorter periods than those who were not. Diclofenac was not avoided in asthmatic patients. Data on 380 children showed they suffer similar types of nonserious adverse reactions to adults. The incidence (95% confidence interval) of rash was 0.8% (0.016, 2.3); minor central nervous system disturbance 0.5% (0.06, 1.9); rectal irritation with suppositories 0.3% (0.009, 1.9); and diarrhoea 0.3% (0.007, 1.5). No serious adverse event was judged to be caused by diclofenac, meaning the incidence of serious adverse reactions to diclofenac in children is <0.8%. CONCLUSION Children given diclofenac for acute pain appeared to suffer similar types of adverse reactions to adults; the incidence of serious adverse reaction is <0.8%. © 2009 The British Pharmacological Society.en_US
dc.languageengen_US
dc.publisherBlackwell Publishing Ltd. The Journal's web site is located at http://www.blackwellpublishing.com/journals/BJCPen_US
dc.relation.ispartofBritish Journal of Clinical Pharmacologyen_US
dc.subject.meshAdverse Drug Reaction Reporting Systemsen_US
dc.subject.meshChilden_US
dc.subject.meshChild, Preschoolen_US
dc.subject.meshConfidence Intervalsen_US
dc.subject.meshDiclofenac - Adverse Effectsen_US
dc.subject.meshDrug Toxicity - Chemically Induceden_US
dc.subject.meshFemaleen_US
dc.subject.meshHumansen_US
dc.subject.meshIncidenceen_US
dc.subject.meshInfanten_US
dc.subject.meshMaleen_US
dc.subject.meshPain - Drug Therapyen_US
dc.subject.meshProspective Studiesen_US
dc.titleProspective observational study of adverse drug reactions to diclofenac in childrenen_US
dc.typeArticleen_US
dc.identifier.emailWong, ICK:wongick@hku.hken_US
dc.identifier.authorityWong, ICK=rp01480en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1111/j.1365-2125.2009.03447.xen_US
dc.identifier.pmid19694745-
dc.identifier.scopuseid_2-s2.0-68449104872en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-68449104872&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume68en_US
dc.identifier.issue2en_US
dc.identifier.spage243en_US
dc.identifier.epage251en_US
dc.identifier.isiWOS:000268789700014-
dc.publisher.placeUnited Kingdomen_US
dc.identifier.scopusauthoridStanding, JF=8702431000en_US
dc.identifier.scopusauthoridOoi, K=35810893000en_US
dc.identifier.scopusauthoridKeady, S=6602621384en_US
dc.identifier.scopusauthoridHoward, RF=7403674211en_US
dc.identifier.scopusauthoridSavage, I=7004074225en_US
dc.identifier.scopusauthoridWong, ICK=7102513915en_US
dc.identifier.citeulike5446022-

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