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Three Part Question

[In children with suppurative otitis media] is the [topical application of antibiotics superior to systemic antibiotc treatment] at [decreasing purulent discharge and time to clinical recovery]?

Clinical Scenario

A three year old girl with the first episode of a febrile unilateral otitis media with purulent discharge and otalgia is brought to Children's Emergency. As usual you would prescribe oral amoxicillin but the consultant who happens to stand next to you when filling out the prescription advises you to use antibiotic eardrops instead. They would just be better.

Search Strategy

Medline 1966-11/07 using the Ovid interface
Cochrane Library, Issue 4, 1996 -11/07
Maternity and Infant Care 1971-11/2007 using the Ovid interface
Medline:
# Search History Results
1 Child/ 1073545
2 Infant/ 510399
3 1 or 2 1289321
4 exp Anti-Infective Agents/ 989500
5 otitis media/ or otitis
media, suppurative/
or tympanic membrane
perforation/ 14740
6 3 and 4 and 5 2044
7 limit 6 to (humans and
english language and
yr="1966 - 2007") 1562
Chochrane:
otitis media AND topical AND antibiotic* AND "child* OR infan*"
Maternity and Infant Care:
Standard-Searchterm: PN136.sx

Search Outcome

Altogether 1562 papers were found in Medline, 50 in the Cochrane Library and 90 in Maternity and Infant Care, of which in total 4 were relevant. One of those compared topical ofloxacin for chronic suppurative otitis media (CSOM) against a not defined "historical-practice control" or "current-practice control" respectively and was therefore excluded. All three remaining papers addressed either chronically discharging ears or acute otitis media in children with tympanostomy tubes. No randomized clinical trials including children with acute purulent otitis media and spontaneous eardrum perforation were found.

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Dohar J., et al. 2006 USA	80 children 96 ears Age 0-12 y	Multicenter RCT	Median time of cessation of otorrohea	topical: 4.0 days, systemic: 7.0 days, P=.0006	Included only children with otorrhea through tympanostomy tubes (TTO); Use of combination of topical antibiotic with steroid component; Sponsored by Alcon Research Ltd
			Clinical cure on day 18	topical: 84.6%, systemic: 58.5%, P=.0100
			Microbiological: Eradication on day 18	topical: 74.2%, systemic: 55.2%, P=.1227
Goldlatt EL, at al. 1998 USA	286 evaluable children Age: 1-12 y	Multicenter RCT	curing the clinical signs and symptoms of otorrhea after 10 days treatment	Difference between groups is not statistically significant (95% CI -3.7 to 18.2%), P=.169	Included only children with otorrhea through tympanostomy tubes (TTO); Excluded patients with systemic symptoms (e.g. fever); Wide CI including 0 for eradication of P. aeruginosa and Staph. aureus Sponsored by Daiichi Pharmaceutical Corporation;
			Eradication on day 10 for S. pneumoniae, H. influenzae, and M.catarrhalis	Not statistically significant
			Eradication on day 10 for P. aeruginosa and Staphylococcus aureus	Statistically significant,95% CI, -18,2 to 41,2%, P < .05 for both
Macfayden CA, et al. 2006 USA	Nine trials with 833 patients 842 ears Age ¡Ý 6 y	Systemic Review of RCTs	Primary : Resolution of CSOM at 1 to 2 weeks and at 2-4 weeks according to the investigators¡¯ criteria	Topical quinolone antibiotics better than systemic antibiotics at 1-2 weeks, 95% confidence interval (CI) 1.88 to 5.49, No statistically significant benefit was seen at 2-4 weeks for topical nonquinolone antibiotic over systemic antibiotics	Adults included in patient groups, 4 trials with adults only, unknown number of treated children; CSOM definitions and severity varied; Methodological quality varied; Range of different applications and groups of systemic antibiotics (i.m., oral, i.v.); Small numbers (N=31) for topical non-quinolones

Comment(s)

Aural toilet was not discussed in several trials, but regularly performed in others. It surely appears to be a useful procedure in order to increase local concentration of the applied ototopics at the very region of interest, but this issue as well as safety of application of those antibiotics were not subject of this BET. Some national drug authorities (e.g. Australia and USA) have not yet approved or have limited the use the of ototopical quinolone-preparations. No published trials concerning children with acute otitis media and spontaneous perforation of the eardrum have been found. In children with chronic suppurative otitis media or tympanostomy tubes the topical application of antibiotics may have a better outcome than systemic antibiotics. This may be beneficial especially if children are refusing to take oral antibiotics, vomit or have an uncertain enteral absorption for other reasons. National approvals and local guidelines still have to be considered.

Clinical Bottom Line

No published evidence was found to answer the initial question, national approvals and local guidelines should be followed.

References

1. Dohar J, Giles W, Roland P, et al Topical ciprofloxacin/dexamethasone superior to oral amoxicillin/clavulanic acid in acute otitis media with otorrhea through tympanostomy tubes Pediatrics 118(3):e561-9, 2006 Sep
2. Goldblatt EL, Dohar J, Nozza RJ, et al. Topical ofloxacin versus systemic amoxicillin/clavulanate in purulent otorrhea in children with tympanostomy tubes International Journal of Pediatric Otorhinolaryngology 46(1-2):91-101, 1998 Nov 15
3. Macfadyen CA, Acuin JM, Gamble C Systemic antibiotics versus topical treatments for chronically discharging ears with underlying eardrum perforations Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD005608. DOI: 10.1002/14651858. CD005608