Clinical Case: “Doctor, I want to have a referral to an ENT. Sophie keeps getting ear infections and I was told by a friend that grommets will help.” I get questions like these (or similar) quite regularly as there seems to be quite a push from local GPs to refer to ENT early for grommets.
At the moment I generally do a history on development, hearing, speech and language. Address any other chronic medical illnesses or red flags. I enquire on vaccination status. I ask about childcare/other sick contacts. I ask about how many infections she has had in the last 6 months. Then I look in the ears to see if I can see an effusion (looking at light reflex, drawn in or bulging, and obviously acute infection signs). I try and get them to do a valsalva while examining the drum. If there is fluid and it is 6 wks or more since recent illness I send them for a hearing test in town and confirmation of fluid. If this is positive then I generally have been referring to ENT for grommets.
But what is the evidence? Who really needs them? And how will it help with infections, hearing, or schooling?
Question – What are grommets/tympanostomy tubes/ventilation tubes and how do they work?
Grommets or ventilation tubes are small, usually plastic tubes inserted into the child’s eardrum to ventilate the middle ear space. In America, 667,000 children under 15 have these placed (I cannot find Australian statistics?) They are usually placed because of persistent middle ear fluid, frequent ear infections, or ear infections that persist after antibiotics. – Link
Question – How often do we use grommets in Australia?
I looked for ages to try and find some statistics on the use of grommets/tympanostomy tubes in Australia and got no where. If someone knows where this data is can they leave a message for me and I’ll update the map!
Question – How can I make sure a child has a middle ear effusion on exam?
For a great reminder of what we are looking for in otoscopy John Hopkins 2010 has a great guide to diagnosis of Acute Otitis Media (AOM) and Otitis Media with effusion (OME) – Link
Slightly older but with nice Australian details is an AFP article on Otoscopy – A practical guide 2005 – Link
Finally, a 2013 lecture notes from GP13 on a GP’s perspective of diagnosing middle ear disease by Prof Jenny Reath – Link
Question – Do grommets reduce the amount of recurrent acute otitis media in children?
An article in the MJA 2009 on Primary Care management of Acute Otitis Media suggested “The current recommendation for tympanostomy tube placement is three or more separate episodes of AOM in 6 months, or four or more episodes in 12 months.” – Link
This is based upon a Cochrane Review from 2011 which states – “One of the two included studies (from available studies unsuitable for meta-analysis), involving 95 children, showed that grommets reduce the number of episodes of acute otitis media in the first six months after surgery, by an average of 1.5 episodes per child.” – Link
This is also supported by an article in Australian Prescriber looking at recurrent otitis media from 2009 which also stated – “In 5 studies (424 participants), acute otitis media episodes were reduced from 1 to 2 episodes per year.” – Link
New 2013 guidelines from America in Otolaryngology – Head and Neck Surgery – Clinical Practice Guidelines for Tympanostomy tubes in Children – admits that the evidence for tympanostomy tubes to prevent AOM is not strong. This is a great detailed article if you are more interested in this topic – Link
So, the evidence is poor, and the scant evidence that we have suggests that we prevent 1.5-2 episodes of AOM for 6 months by going through with tympanostomy tubes and surgery. I am not overly convinced to be honest.
I was under the impression that grommets were useful, particularly around school age kids, to help with long term schooling and language and speech development.
“Evidence suggests that grommets only offer a short-term hearing improvement in children with simple glue ear (otitis media with effusion or OME) who have no other serious medical problems or disabilities. No effect on speech and language development has been shown.” – Cochrane Review 2010 – Link
“…the beneficial effect of grommets on hearing was present at six months but diminished thereafter. Most grommets come out over this time and by then the condition will have resolved in most children.” The Cochrane Review then goes on to state – “Active observation would appear to be an appropriate management strategy for the majority of children with bilateral glue ear as middle ear fluid will resolve spontaneously in most children.” – Link
And once again all this is supported in the latest guidelines from America 2013 which also state evidence for the benefits on speech and language is lacking (pg55) – Link
Ok so not impressed by the benefits for speech and language either. Given the duration of time which we have been placing tympanostomy tubes I am not highly impressed by the small studies – and neither am I overly impressed by a reduction in 1.5 or 2 infective episodes for the cost and effort of grommets? Also, it seems Cochrane does not show any benefit of hearing, or on schooling outside of 6 months?
Question – Ok. So when should we recommend grommets then?
These are the RELEVANT (some were surgical suggestions I have omitted) suggestions from the Otolaryngology – Head and Neck Surgery 2013 consensus guidelines: Link – NB: These are written by ENT surgeons.
1. Clinicians should NOT perform tympanostomy tube insertions with single episode of otitis media with effusion (OME) of less than 3 months duration.
2. Clinicians should perform age appropriate hearing tests if OME greater than 3 mths and considering tympanostomy tubes
3. Clinicians should offer bilateral tympanostomy tube insertion to children with bilateral OME for 3 mths of longer and documented hearing difficulties – Evidence seems scanty for this?
5. Clinicians should re-evaluate at 3-6mth intervals if tympanostomy tubes are not placed.
6. Clinicians should NOT perform tympanostomy tube insertion in children with recurrent AOM who do NOT have middle ear effusion.
8 & 9. Clinicians should evaluate baseline sensory, physical, cognitive, or behavioural factors if they have recurrent AOM or with OME and are at risk they should be offered tympanostomy tubes.
12. Clinicians should NOT recommend routine, prophylactic water precautions (eg Ear plugs) for children with tympanostomy tubes.
Question – Can anything go wrong with Grommets and what do they cost?
Placing of grommets takes approximately 20 minutes and is done as a day procedure. Complications include risks with anaesthesia (death from 1 in 10,000 to 1 in 45,000 anaesthetics), myringosclerosis (white calcification after tubes. Rarely causes significant hearing issues), and persistent perfusion with or without otorrhea (discharge from ear) (occurs in 16% of children within 4 weeks of surgery and 26% at any time tube is in place).
Chronic perforations occur in 2% of children with tympanostomy tubes and 17% with long-term tubes.
There is evidence that children who have had tympanostomy tubes have a long term 1- to 2-dB worsening in hearing thresholds versus those that did not (which is trivial). All these complication details are from the American Otolaryngology consensus guidelines – Link
They are not overly cheap either. Costs across Australia seem to vary significantly. Trying to find costs online is pretty impossible. Most people are looking at at least $1000 out of pocket privately (please put below if you know the price is different where you are). Different places have varying waiting times for both public and private.
Question – Are there any other factors to consider?
Yes. Lower socioeconomic groups, refugee populations and and Aboriginal and Torres Strait Islander people have greater risk of middle ear effusion. These groups have not had good studies however there is suggestion that because their pretest probability of CSOM is higher and their rate of complications (infections and hearing issues) is also higher then they warrant earlier treatment and referral – MJA 2010 – Link
For more information on treating OME in Aboriginal and Torres Strait Islander populations is available in the “Management of Otitis Media in Aboriginal and Torres Strait Islander Populations – updated 2010.” Everyone knows I love a flow chart – this is a good one! – Link
Also patients at higher risks because of speech, language, neurocognitive or any other disabilities that may cause schooling difficulties may be more greatly affected by poor hearing so they suggest these kids are also referred earlier. No evidence really but makes pretty good common sense.
Question – How long does it take for OME resolve and what else can we do?
MJA 2009 suggests that “For children with effusions persisting for 3 months, the rate of spontaneous resolution is only about 20% over the next 3 months.”
- 3 months – 56 percent (95% CI 51-61 percent)
- 6 months – 72 percent (95% CI 68-76 percent)
- 9 months – 81 percent (95% CI 77-85 percent)
- 12 months – 87 percent (95% CI 80-94 percent)
What about other treatment options? I was taught a long course of antibiotics can be tried (never used it though).
A Cochrane Database review in 2012 looked at this question. Looking at 23 RCT’s of 3027 children with a primary outcome of resolution of OME at 2-3months. The results did not support routine use of prolonged antibiotics (from 7 days to 12 months). Because of the negatives of long term antibiotics they do not recommend the evidence is strong enough to suggest prolonged ABs to treat OME – Link
Therapeutic Guidelines 2013 suggest the use of amoxycillin, cefuroxime, or cefaclor at doses used for AOM for 10-30 days can be tried – especially in indigenous populations. I am not sure the evidence supports this but I assume this is a consensus expert opinion.
“There is no evidence of sustained benefit from oral or topical steroids. Similarly, decongestants and antihistamines are of no benefit” – MJA
AAFP has an article in 2005 on Treatments for Persistent Otitis Media with Effusion. “Treatments such as antibiotics, steroids, antihistamines/decongestants, and mucolytics afford no long-term benefit in the treatment of patients with otitis media with effusion (OME). [Strength of recommendation: A]” – AAFP 2005 – Link
Homeopathy, probiotics, and other complementary and alternative therapies either have no, or equivocal research in their effects on OME. The 2008 NICE surgical guidelines recommend against the use of these – Link
And finally, what about valsalva maneuvers?
Articles often talk about valsalva maneuvers (or autoinflation) to clear the middle ear effusion. What are these valsalva maneuvers or autoinflation? It is explained in this video – Otovent video – Link – (I don’t endorse any type – just chose the most colourful video! Could you make one of these?)
A recently updated Cochrane review (2013) suggested that though the studies are small (702 participants) and there are some technical issues with them, there is suggestion that there was improved audiometry at one month after use of autoinflation devices. They suggest as the cost is low and there is very little chance of adverse outcomes that this could be tried in patients with effusion at 3mths – Cochrane 2013 – Link
Vaccinations to Streptococcus pneumoniae and Haemophilus influenzae (two of the most common bacterial pathogens) have both shown reduced levels of otitis media and requirement for tympanostomy insertion but results were not as dramatic as expected – Vaccine 2008 – Link
Question – What do I do with the child who has grommets for swimming/water/travel, and if they have discharge?
Patients with tympanostomy tubes in place will have another episode of AOM in 15-26% of cases. Children will rarely experience fever or pain – often just otorrhea. In most cases this resolves with drops alone – 2013 otolaryngologist guidelines.
Therapeutic guidelines 2013 suggest that patients with discharge from the ears with grommets requires aural toilet 6 hourly (or clearing the external canal – they suggest using dry spears – great video from Australian Indigenous Healthinfonet – Link) and if aural discharge is from a recent perforation (tympanostomy within last 6 weeks or perforation) then give antibiotics orally and corticosteroid and antibiotic combination drops topically.
“Dexamethasone 0.05% + framycetin 0.5% + gramicidin 0.005% ear drops 3 drops instilled into the ear, 6-hourly until the middle ear has been free of discharge for at least 3 days. Do not administer for longer than 7 days”
“Amoxycillin 15 mg/kg up to 500 mg orally, 8-hourly for 5 days”
If discharge is after 6 weeks from the perforation then they suggest using drops only.
Debate about the use of aminoglycoside with non intact tympanic membranes has shown that use for 7 days or more is used in increased ototoxicity. They suggest changing to topical quinolones if non intact membranes after 7 days. They suggest not to use this as first line because of resistance.
If persistent discharge, refer to ENT.
Water precautions – Clinicians should NOT encourage routine, prophylactic water precautions (use of earplugs, headbands, avoidance of swimming or water sports) for children with tympanostomy tubes
Over the counter otic drops are NOT safe for use with tympanostomy tubes regardless of the indication (eg. earwax, swimmer’s ear, discomfort).
Children are also often uncomfortable with loud noises after the grommets are placed due to increased sensitivity of the vestibulocochlear nerve.
Question – Any patient information to give out?
Here is a good patient hand out from NSW Health for patients who have grommets on follow up cares and complications – Westmead and Sydney Children’s Hospital – Link
So, final thoughts and what will I do in the future?
So what will I say to Sophie’s mother. Firstly, I need to confirm that she has otitis media with effusion and I will use my otoscopy skills and history taking to assess this. I will also assess on history what her risk factors are for significant ongoing problems eg. Downs syndrome, speech and language deficits.
Next, how long has she had it? If she has had it for 3 months then the chances of it resolving on its own after this time decrease.
I will then refer her for a hearing assessment to confirm my diagnosis and also to gauge the severity of the hearing loss.
I will then talk to her about her options.
Firstly, we can refer to ENT and she can have grommets placed that will last approximately 8-13 mths, improve her childs hearing for this time, and may decrease the amount of infections she has within the next 6mths by approximately 1-2 episodes. Grommet placement has risks with the most significant being the anaesthetic risks. There is no evidence of any benefit over the long term to her child’s hearing, speech and language abilities.
The second option is we could teach them valsalva maneuvers and attempt to clear the effusion for up to 4 weeks while still retaining the option for grommets.
The third option is we can watch and wait. I can tell her that 90% of kids will have cleared the effusion at 12 months and the evidence suggests there will be no negative outcome for her child in hearing, speech, or language skills in the future versus grommets being placed. If we choose this option I will reassess the child for resolution and/or complications on a 3-6mthly basis.
Thanks for reading everyone! Send me a message below or on Twitter – @Robapark – Doc Rob!