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BMJ. 1991 September 7; 303(6802): 558–562.
PMCID: PMC1670875

Acute red ear in children: controlled trial of non-antibiotic treatment in general practice.


OBJECTIVE--To examine the efficacy and safety of conservative management of mild otitis media ("the acute red ear") in children. DESIGN--Double blind placebo controlled trial. SETTING--17 group general practices (48 general practitioners) in Southampton, Bristol, and Portsmouth. PATIENTS--232 children aged 3-10 years with acute earache and at least one abnormal eardrum (114 allocated to receive antibiotic, 118 placebo). INTERVENTIONS--Amoxycillin 125 mg three times a day for seven days or matching placebo; 100 ml paracetamol 120 mg/5 ml. MAIN OUTCOME MEASURES--Diary records of pain and crying, use of analgesic, eardrum signs, failure of treatment, tympanometry at one and three months, recurrence rate, and ear, nose, and throat referral rate over one year. RESULTS--Treatment failure was eight times more likely in the placebo than the antibiotic group (14.4% v 1.7%, odds ratio 8.21, 95% confidence interval 1.94 to 34.7). Children in the placebo group showed a significantly higher incidence of fever on the day after entry (20% v 8%, p less than 0.05), mean analgesic consumption (0.36 ml/h v 0.21 ml/h, difference 0.14, 95% confidence interval 0.07 to 0.23; p = 0.0022), mean duration of crying (1.44 days v 0.50 days, 0.94; 0.50 to 1.38; p less than 0.001), and mean absence from school (1.96 days v 0.52 days, 1.45; 0.46 to 2.42; p = 0.0132). Differences in recorded pain were not significant. The prevalence of middle ear effusion at one or three months, as defined by tympanometry, was not significantly different, nor was there any difference in recurrence rate or in ear, nose, and throat referral rate in the follow up year. No characteristics could be identified which predicted an adverse outcome. CONCLUSIONS--Use of antibiotic improves short term outcome substantially and therefore continues to be an appropriate management policy.

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Selected References

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  • Mills RP. Policies on antibiotics of south east London general practitioners for managing acute otitis media in children. Br Med J (Clin Res Ed) 1984 Apr 21;288(6425):1199–1201. [PMC free article] [PubMed]
  • Browning GG. Childhood otalgia: acute otitis media. 1. Antibiotics not necessary in most cases. BMJ. 1990 Apr 14;300(6730):1005–1006. [PMC free article] [PubMed]
  • Laxdal OE, Merida J, Jones RH. Treatment of acute otitis media: a controlled study of 142 children. Can Med Assoc J. 1970 Feb 14;102(3):263–268. [PMC free article] [PubMed]
  • Howie VM, Ploussard JH. Efficacy of fixed combination antibiotics versus separate components in otitis media. Effectiveness of erythromycin estrolate, triple sulfonamide, ampicillin, erythromycin estolate- triple sulfonamide, and placebo in 280 patients with acute otitis media under two and one-half years of age. Clin Pediatr (Phila) 1972 Apr;11(4):205–214. [PubMed]
  • Dufourcq J, Clin B, Lemanceau B. NMR Study of ganglion-blocking and curare-like dimethoniums conformation in aqueous solutions. FEBS Lett. 1972 May 1;22(2):205–209. [PubMed]
  • Engelhard D, Cohen D, Strauss N, Sacks TG, Jorczak-Sarni L, Shapiro M. Randomised study of myringotomy, amoxycillin/clavulanate, or both for acute otitis media in infants. Lancet. 1989 Jul 15;2(8655):141–143. [PubMed]
  • Froom J, Culpepper L, Grob P, Bartelds A, Bowers P, Bridges-Webb C, Grava-Gubins I, Green L, Lion J, Somaini B, et al. Diagnosis and antibiotic treatment of acute otitis media: report from International Primary Care Network. BMJ. 1990 Mar 3;300(6724):582–586. [PMC free article] [PubMed]
  • van Buchem FL, Dunk JH, van't Hof MA. Therapy of acute otitis media: myringotomy, antibiotics, or neither? A double-blind study in children. Lancet. 1981 Oct 24;2(8252):883–887. [PubMed]
  • van Buchem FL, Peeters MF, van 't Hof MA. Acute otitis media: a new treatment strategy. Br Med J (Clin Res Ed) 1985 Apr 6;290(6474):1033–1037. [PMC free article] [PubMed]
  • Mygind N, Meistrup-Larsen KI, Thomsen J, Thomsen VF, Josefsson K, Sørensen H. Penicillin in acute otitis media: a double-blind placebo-controlled trial. Clin Otolaryngol Allied Sci. 1981 Feb;6(1):5–13. [PubMed]
  • Mills R, Uttley A, McIntyre M. Relationship between acute suppurative otitis media and chronic secretory otitis media: role of antibiotics. J R Soc Med. 1984 Sep;77(9):754–757. [PMC free article] [PubMed]
  • Jerger J. Clinical experience with impedance audiometry. Arch Otolaryngol. 1970 Oct;92(4):311–324. [PubMed]
  • Teele DW, Klein JO, Rosner B. Epidemiology of otitis media during the first seven years of life in children in greater Boston: a prospective, cohort study. J Infect Dis. 1989 Jul;160(1):83–94. [PubMed]
  • Kaleida PH, Casselbrant ML, Rockette HE, Paradise JL, Bluestone CD, Blatter MM, Reisinger KS, Wald ER, Supance JS. Amoxicillin or myringotomy or both for acute otitis media: results of a randomized clinical trial. Pediatrics. 1991 Apr;87(4):466–474. [PubMed]
  • Chaput de Saintonge DM, Levine DF, Savage IT, Burgess GW, Sharp J, Mayhew SR, Sadler MG, Moody R, Griffiths R, Griffiths S, et al. Trial of three-day and ten-day courses of amoxycillin in otitis media. Br Med J (Clin Res Ed) 1982 Apr 10;284(6322):1078–1081. [PMC free article] [PubMed]
  • Jones R, Bain J. Three-day and seven-day treatment in acute otitis media: a double-blind antibiotic trial. J R Coll Gen Pract. 1986 Aug;36(289):356–358. [PMC free article] [PubMed]

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