OM with tubes: consensus statement needed

August 2004

---Philip A. Brunell, MD

The AAP has just produced two excellent statements, one on acute otitis media (AOM) and a second on otitis media with effusion (OME), both in the May issue of Pediatrics. What were not addressed were the thousands of cases of otitis media in kids who have tympanostomy tubes (AOMT). In 1996, tympanostomy tubes were placed in more than half a million children, and about 80% of these children can be expected to have at least one episode of AOMT during the first year. This is a common problem in need of academy guidelines.

Placing tubes

The latest guidelines for OME are a bit more conservative with respect to when one should consider tube placement, which probably is prudent in light of the uncertainty about the long-term benefits of this procedure. Evidence that is appearing would support this position. One must measure the benefit derived against the costs in dollars and in complications. The long-term goal is to have children achieve optimal development. The concern that prompts tube placement is that “sustained hearing loss during supposedly critical or sensitive periods of children’s development may result in lasting impairments of the children’s speech, language or cognitive skills or their psychosocial adjustment.”

The results of a prospective long-term follow-up study of children with OME to determine the effect of duration of effusion on these parameters have been appearing over the past few years (Pediatrics. 2003;112:265). The results at 4 years of age are particularly useful, as many of these parameters are easier to assess at this age than when measured in younger children. It is important to recognize that these children were compared on the basis of the proportion of time that they experienced effusion with diminished hearing during early childhood rather than by the criteria in the new guidelines.

Given this caveat, the authors concluded that duration of effusion and their developmental outcomes were generally weak and, in most instances, of no significance. A large battery of tests was performed, and there were a few statistically significant but questionably clinically significant differences found. One of the major findings of the study is that delay in tube placement did not adversely affect outcome, supporting the current recommendations for delay beyond three months. These findings should not be applied to children with underlying developmental problems. Additional analysis and longer follow-up may reveal additional findings of importance.

One should appreciate that OME is a normal consequence of AOM and will resolve in most children after three to six months. Thus the caveat about waiting for several months before recommending tube placement. OME is found frequently by screening children during early childhood. In the long-term follow-up study, few of the children whose parents declined tube placement or were not included in the study had persistent effusion at age 4, and these were fewer than at age 3 (Pediatrics. 2003;112:265). The AAP report cites studies indicating point prevalence of effusion of between 15% and 40% in children up to 5 years.

AOM may produce structural abnormalities in the tympanic membrane in the absence of tubes, but these are more frequent after tube placement (Pediatrics. 2004;113:e58). These do not appear to affect hearing, with the exception of the combination of retraction and sclerosis only in the right ear. Hearing at age 6 in all groups, operated or not, early or late placement of tubes, was normal. (Pediatrics. 2004;113:e58) The only complication of note was perforation, which was found in 2.2% of ears.

Treating AOMT

The most common complication of tube placement is otorrhea, which occurs in about 80% of children during the first year. The high frequency is not surprising in that AOM, the cause of otorrhea, is frequent in this age group in children with and without tubes. Some studies have shown that AOM may be decreased after tube placement (Bluestone and Klein, “Otitis Media in Infants and Children” 3rd ed. Philadelphia: W.B Saunders, 2000).

Eardrops for treating AOMT are generally accepted as an alternative to the use of systemic antimicrobials. One study comparing the two modes of therapy indicated there was no difference in outcome (Int J Pediatr Otorhinolaryngol. 1998;46:91). The dose of oral amoxicillin-clavulanate (Augmentin, GlaxoSmithKline) in this study was half of what is now recommended.

This study has been criticized by the exclusion of children from whom Pseudomonas was recovered. However, this is not a cause of AOM. Many question the significance of the finding of this organism in AOMT, which often is found with other bacteria, and believe it originated from water in children who had been swimming without ear protection. This may account for the more frequent finding of Pseudomonas in older children.

In applying the guidelines to AOMT, one should probably not withhold therapy from these children. In a placebo-control study, amoxicillin-clavulanate sterilized and hastened drainage over placebo. Although 41% of the placebo group had spontaneous cessation of drainage during the first week after onset, bacteria cleared more rapidly if amoxicillin-clavulanate was given — mean of one vs. eight days (Pediatrics. 2003:111:1061). One of the children taking placebo developed AOM, which also would argue in favor of systemic therapy.

Although one has the option of either using ear drops or less expensive systemic therapy for AOMT, most would prefer systemic therapy if there is an upper respiratory infection, especially if there is fever. Fluoroquinolone eardrops, as compared with systemic administration, are said to not put children at risk of joint problems, as little appears in the circulation. The fact that small amounts may get into the system, however, may invalidate the claim that local application will not result in resistance.

In any case, children with AOMT should be followed to assure that drainage has ceased. For those with persistent drainage, one should assure that treatment has actually been given. The mean duration of drainage is four to six days when eardrops are used (Pediatrics. 2004;113:e58) and three days with amoxicillin-clavulanate (Pediatrics. 2004;113:e58). Prolonged drainage would probably be an indication for culture. This should be performed after carefully cleaning the ear and trying to obtain material directly from the orifice of the tube. Occasionally, one may find a highly resistant bacteria or fungus.

Cleaning pus from the ear should be done at least at the first office visit, especially if one is using topical therapy. Parents should be instructed as to proper administration of drops, including “pumping the ear.” Many favor placement of cotton wicks.

For children who have persistent drainage, a referral to an otolaryngologist for evaluation is probably prudent. They will clean the ear, perform an otomicroscopic examination and obtain cultures from the tube orifice. It is not uncommon to find an organism different from the original one (Pediatrics. 2003:111:1061). Therapy may be changed or the child might require hospitalization for parenteral therapy or for surgery.

For those who choose not to prescribe systemic therapy, a topical agent must be chosen. A committee of otolaryngologists has expressed a preference for drugs that are not potentially ototoxic, ie, fluoroquinolones, in the presence of a communication between the middle ear and external ear canal. If the less-expensive aminoglycoside-containing antibiotics are used, they advise it be for no more than two weeks, and patients should be warned about the risk of vestibular or cochlear toxicity (Otolaryngol Head Neck Surg. 2004;130:s79). The addition of a steroid to the antibiotic eardrops appeared to offer some advantage (Pediatrics. 2004;113:e40).

Tube placement, although quite popular, has its cost in dollars and morbidity, the most common of which is AOMT. The number of children requiring tube placement is reduced by 24% in those receiving pneumococcal conjugate vaccine (Pediatr Infect Dis J. 2003;22:1). The guidelines are helpful in choosing those children who might benefit from tube placement. Additional data from long-term follow-up studies will help us to better weigh the advantages and disadvantages of this procedure. Popularity does not necessarily coincide with efficacy. It took decades until we learned the limited use of tonsillectomy in the prevention of pharyngitis.

For more information:

• AAP Subcommittee on Management of Acute Otitis Media. Diagnosis and management of acute otitis media. Pediatrics. 2004;113(5):1451-1465.
• American Academy of Family Physicians; American Academy of Otolaryngology-Head and Neck Surgery; AAP Subcommittee on Otitis Media With Effusion. Otitis media with effusion. Pediatrics. 2004 May;113(5):1412-1429.
• Ah-Tye C, et al. Otorrhea in young children after tympanostomy-tube placement for persistent middle-ear effusion: prevalence, incidence, and duration. Pediatrics. 2001;107(6):1251-1258.
• Paradise JL, et al. Otitis media and tympanostomy tube insertion during the first three years of life: developmental outcomes at the age of four years. Pediatrics. 2003;112(2):265-277. Otitis media and speech and language: a meta-analysis of prospective studies. Pediatrics. 2004;113(3 Pt 1):e238-248.
• Goldblatt EL, et al. Topical ofloxacin versus systemic amoxicillin/clavulanate in purulent otorrhea in children with tympanostomy tubes. Int J Pediatr Otorhinolaryngol. 1998;46(1-2):91-101.
• Ruohola A, et al. Antibiotic treatment of acute otorrhea through tympanostomy tube: randomized double-blind placebo-controlled study with daily follow-up. Pediatrics. 2003;111(5 Pt 1):1061-1067.
• Roland PS, et al. Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes. Pediatrics. 2004;113(1 Pt 1):e40.