title: Prospective observational study of adverse drug reactions to diclofenac in children.
abstract: OBJECTIVE
  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 < or =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%.
  
  
  CONCLUSIONS
  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%.
authors.affiliation: Great Ormond Street Hospital for Children, School of Pharmacy, University of London, London, UK. joseph.standing@farmbio.uu.se
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Standing
authors.forename: Kuan
authors.initials: K
authors.lastname: Ooi
authors.forename: Simon
authors.initials: S
authors.lastname: Keady
authors.forename: Richard F
authors.initials: RF
authors.lastname: Howard
authors.forename: Imogen
authors.initials: I
authors.lastname: Savage
authors.forename: Ian C K
authors.initials: IC
authors.lastname: Wong
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D002648:Child; D002675:Child, Preschool; D016001:Confidence Intervals; D004008:Diclofenac / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced*; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D010146:Pain / Q000188:drug therapy*; D011446:Prospective Studies
chemical_list: D004008:Diclofenac
references.citation: BMJ. 1998 Jan 31;316(7128):343-5
references.pmid: 9487167
references.citation: Clin Pharmacol Ther. 1981 Aug;30(2):239-45
references.pmid: 7249508
references.citation: Pediatrics. 2002 Feb;109(2):E20
references.pmid: 11826230
references.citation: Paediatr Anaesth. 2001 Jul;11(4):431-6
references.pmid: 11442860
references.citation: J Allergy Clin Immunol. 2003 May;111(5):913-21; quiz 922
references.pmid: 12743549
references.citation: Br J Clin Pharmacol. 2006 Jun;61(6):716-9
references.pmid: 16722834
references.citation: Cochrane Database Syst Rev. 2009 Oct 07;(4):CD005538
references.pmid: 19821348
references.citation: JAMA. 2003 Aug 20;290(7):905-11
references.pmid: 12928467
references.citation: Lancet. 2000 Oct 7;356(9237):1255-9
references.pmid: 11072960
references.citation: Br J Clin Pharmacol. 2008 Dec;66(6):846-53
references.pmid: 19032726
references.citation: Am J Med. 1998 May;104(5):413-21
references.pmid: 9626023
references.citation: Surg Neurol. 1997 Jan;47(1):32-4
references.pmid: 8986162
references.citation: Anaesthesia. 2000 Apr;55(4):334-7
references.pmid: 10781118
references.citation: Pediatrics. 1986 Jun;77(6):848-9
references.pmid: 3714377
references.citation: J Chronic Dis. 1965 Jan;18:77-98
references.pmid: 14252273
references.citation: JAMA. 1983 Apr 1;249(13):1743-5
references.pmid: 6827763
references.citation: Acta Paediatr. 1999 Sep;88(9):965-8
references.pmid: 10519338
references.citation: Soc Hist Med. 2006 Apr;19(1):127-47
references.pmid: 17153164
references.citation: Drug Saf. 2002;25(1):1-5
references.pmid: 11820908
references.citation: Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003591
references.pmid: 15846670
references.citation: BMJ. 2004 Jul 3;329(7456):15-9
references.pmid: 15231615
references.citation: N Engl J Med. 2003 Sep 18;349(12):1157-67
references.pmid: 13679531
references.citation: Fam Community Health. 1982 Aug;5(2):58-67
references.pmid: 10278126