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Otitis Media

Victoria L. Franklin, MD

 

When you go to make the diagnosis of otitis media, see the whole tympanic membrane. Diagnose it based on some criteria. Try to make that diagnosis as strict as you can. And then use your antibiotics in as precise a fashion as you can and follow them up until you know they are better.

Otitis media is any kind of inflammation in the middle ear and there are two basic kinds. Thereís acute otitis media and thereís otitis media with effusion and weíll talk a little bit about the difference and why we really want to make a clean distinction on those a little bit later. Whatís interesting is that up to a third of them come in for other things. Theyíll come in for their fever but they are not having any ear pain. Theyíll come in for their decreased appetite and they are just acting really nasty and mean and mom doesnít know why in the world this child is acting so bad. But they really arenít complaining about the ears. But it has become the number one treatable - at least for which treatment is suggested to be most likely possible and probably effective. And millions and millions of dollars are spent on this disease every year. What we worry about is over-diagnosis. We used to say, "Gee, we donít want to miss any." Now we have a whole different paradigm. We are looking for reasons not to use antibiotics nowadays, arenít we? Instead of looking for reasons to use antibiotics. We are trying to cut down on resistance and itís real hard to do that when you are out there in the trenches and mom comes in with a fever, she really expects that antibiotic no matter what you tell her. Weíve got to really make sure weíve really got otitis media.

What shall we tell the parents when they come in for their first well-check? This is the time you hit them up with this. Because you know everybody is going to have some. So you tell people about this. That while 15% donít get otitis media by the time they are three, almost everybody else does. What we expect is for every child to have three otitisís every winter. If you can stay to three or less, you are normal. You are average. Thatís out goal. Keep it to three or less. Itís only those ones down in the bottom that have more than three that need all that special extra attention. So give them a signpost. Iím not going to get worried, Iím not going to want to do any crazy special stuff unless you have more than three in a winter. Thatís up from the old 1.2 per winter, we used to think was normal. Some reevaluation you may have seen in that paper that came out last fall, said that the average now is three. Itís probably all attributable to the fact that we have daycare.

What are the problems? Well, thereís this plumbing problem - as I call it - where the eustachian tube and the palate are not very mature. You know the eustachian tube, that straight shot, that short floppy eustachian tube canít keep things from refluxing up there and then the muscles donít coordinate well and flush it all back out. Things get trapped up there and cause inflammation. In addition to that, youíve got a nasopharynx full of bacteria. Itís the dirtiest place in the body. It has more bacteria per gram of material than even stool. So itís easy to get bacteria up there. And the adenoids, if they get a little hypertrophied, as you know they are in little kids, they cause that eustachian tube also to not open and close quite as well. So youíve got plumbing problems but they are going to get better as time goes on, but not until they are three to five years old. And if they are malformed, thatís even worse. So the kids with cleft palates, the people with Downís syndrome who have those little tiny eustachian tubes have extra problems.

There is a protective layer where we have antibodies and all these cells and there is some built-in stuff that really should help us, but the problem is we havenít developed immunity to all those things that are out there. In fact, you canít make antibody to pneumococcus until you are bout two-years-old because itís a capsule with polysaccharide. Until we have a conjugate vaccine we canít even immunize people to it. So the first two years are kind of like a given; you are not going to get immune to pneumococcus. Then if you have some innate problem, like you are missing a little IgG or something, that can be a big problem with it as well. So youíve got plumbing problems, youíve got immature immune systems so your second line of defense isnít working as well. Your barriers arenít as good, your immune system isnít as good, and then when you get an infection, the probability of that depends on how many exposures and how high an inoculum - how many of those little critters get up in there. Because if you get a lot of exposures itís going to break through eventually. You get a big inoculum, even your defenses that are there canít overcome it.

Now, some of that is avoidable. How is that avoidable? Keep them out of daycare. If youíve got to use daycare, you are going to see us a lot more. You are going to see us twice as frequently for URIís. Almost three times as much for diarrhea, two-and-a-half times as much for otitis media. Itís just part of being in daycare, so itís one of those things to know about. Some kids, no matter what mom and dad do, they still have problems. They probably just have bad luck.

What are the risk factors? Aged less than two years, big risk, big risk. Thatís a problem. The viral respiratory illness, the daycare, the pacifier over two. Passive smoke, we know about. The propping the bottle. As you get a little older, the risk factors are not as high. And then males have more problems. Around the middle of May things get better and breast feeding tends to reduce otitis media for about 50% while you are breast feeding. Some people think there is a little bit of a honeymoon for a couple of three months thereafter. So this is something you can encourage families who have otitis-prone kids over and over again, try to keep the breast feeding going as long as they can tolerate it. At least until that first year, if you can get them by with it, because it will help cut down the otitis media.

These are the real hard core that you know to deal with. First episode: less than six months. That means that the maternal antibody that came across isnít enough to protect them. Thatís a red flag going up saying "Iíve got the worst eustachian tubes on the planet." So predict them. They are going to be in a lot more. Youíll look like you know what youíre doing because theyíll be back. Three episodes in the last six months: thatís kind of a give away. Native Americans, Downís syndrome, cleft palate, they all are at least twice as frequent to have otitis media and have half the rate of resolution. They donít get well as fast either. They take extra care. Immune deficiencies: Iíve got hens teeth out there. Anybody seen hens teeth? Not very many? You wonít see many immune deficiencies either. Thatís about how frequent they are. The only time you should look for it with otitis media is if theyíve got other systems that are also involved. If theyíve got recurrent pyoderma and otitis media, and diarrhea, and they are failing to thrive, work them up for immune deficiencies. If you want to be a little more liberal with it, the kid who is draining through his tubes, thatís a reasonable person to work up for immune deficiency. Anybody else, you are going to be less than 1:100,000. Itís not worth the money or the pain you put the child through.

Now this is not in the handout but this is just to show us that most URIís happen in the first few years of life. If you look over here, go way down so that by the time you get to be about ten-years-of-age you should only have about one to one-and-a-half URIís a year. If you have a lot of URIís that predisposes you to infections and otitis media is the one that most frequently follows the URI. What we donít want to do is use antibiotics for colds and so we want to make sure weíve got a diagnosis of otitis media.

Hereís the key differentiation. Youíve got mobility, color, position and hearing deficit. Well, hearing deficit is hard to tell in little kids. They arenít really cooperative, you donít have good tools. But what we know is that acute otitis media with effusion, AOME, thatís pus and bugs, infection. Probably needs antibiotics, as opposed to OME, the old serous otitis. If there are bugs in there, they are in very low quantities, they are not producing a lot of inflammation. It does not need antibiotics and this is kind of mucus. What I like to tell parents when they come back and Iíve treated their AOM, their pus and bugs and itísí better, theyíve still got that mucus in that retracted drum, I donít call it otitis. Because if parent hear otitis they think weíve blown it, we havenít cured this. As far as the antibiotics, weíve done what we can do, so I like to tell them that this is just some mucus that needs cleaning up. That nature has to pump out of there over the next month or six weeks. And it makes them a little more susceptible to the next infection, but it is not infection. If they hear "serous otitis" or "otitis media with effusion" they think thereís still something there that needs antibiotics and I think that causes some confusion and frustration. So I like to differentiate those two and make sure they know the difference.

The major difference, as you can see, is there are two. One is the position. If itís bulging, as opposed to neutral or retracted - infection stretches things, makes things swell. When itís cleaning up and itís just the fact that the eustachian tube canít pump enough air up and get the mucus out, it will tend to retract or sit in that neutral position. So position is a very important thing to do.

Mobility: does it move when you both blow in and come out, or does it just move when you come out? Because see, if thereís a vacuum back there you canít push it but you can suck it back. Because you can pull back and it will overcome the vacuum in the middle ear. If itís already full of pus you canít compress it and itís already stretched out so you canít pull it at you. It turns out that that movement alone, if you get it right, will be a 65% predictor of infection. You add to that a bulging position you are up to about 85% prediction. What the color adds is about 5% to 6% and there are 8% you always get wrong. There are 8%, no matter how good we are, we donít get right. So it turns out that color is the least likely predictor in most instances and thatís why we would love to have everybody use pneumatic otoscopy. Now we know everybody doesnít use pneumatic otoscopy and I think the reason is they are using the wrong tool. This is the tool you ought to be using. Not the television screen one. This one that has a round mirror or lens and itís got a barrel thatís silver and a fixed speculum that you put in there. One of the things that you see on here is this little rubber tube here, thatís kind of unsightly and hard to keep clean, but thereís this thing called "Sof-Spec" that costs 14.95 and itís a beveled latex, sterilizable thing that just nestles right down there painlessly and seals the canal. If you want to get back into it, this part doesnít cost any more than the other one and the seals on those old television screen ones only last about two years. So if you try to use them more than two years they are probably not any good. This one, part 20-200 Welch Allen fiberoptic works great and will last the rest of your career. And with Sof-Specís you will find it is so easy to learn how to do this. You can teach yourself. Our medical students learn in less than an hour. But those old specula that used to have that grunge in there. You made the kids hurt and you couldnít get a good seal, and only half the people could learn, this could make a difference and it can make your job of diagnosing otitis a lot easier.

So, pop quiz: what are the problems? Most of these things we canít change. We canít change race, gender, age, maturity or anatomy, at least not in the clinic, in the office. The ones weíd like to change: daycare, smoking parents and avoiding allergens - I donít know, Iíve been trying for 25 years. Iím having trouble getting those to work. So what weíve got to do is weíve got to be as precise with our antibiotics as we can. So how do we try to do that? Well, first youíve got to know that there are different types of otitis media. Theyíre not all created equal. The kid with intermittent otitis media probably has better plumbing and less resistant organisms because he or she hasnít seen as many antibiotics and because they havenít had a lot of trouble, they have been taking care of most of those little refluxing difficulties on their own. So they are going to get better with less potent drugs. The ones who have recurrent or relapsing otitis media, a little worse plumbing, a little worse bacteria. And the ones who have recently failed, or failed in the middle of therapy, and their plumbing is awful. So you are going to have less expectations and less reasonable chance to get better with first line drugs.

If we take the pathogens and break them down by - all in that left column - the ones who have intermittent otitis in the middle and the recurrent ones on the other side in yellow here, you can see the difference in the rates of resistance. The intermediate resistant to penicillin and amoxicillin and cephalosporins, as it turns out. Over there, 15% to 40% beta-lactamase producing. H. flu, 25% to 40% with recurrent persisting. And those are just so much higher and that tells us where we have to really apply our more potent drugs.

If we then look at this thing that we talked about before, in the antibiotic lecture, youíll see that we really have had problems with drug resistant pneumococcus getting more frequent and the thing I want to point out to you here is that down there at the bottom, January to May has twice as many drug resistant pneumococcus as June to September. We reap what we sow over the winter. We start using a lot of antibiotics in September and by Christmas time things go all to heck in a hand-basket. So I call it the New Years Day massacre for antibiotics because they all go a lot worse. Thereís a lot let activity and a lot less efficacy after the first of the year, even with the same or other risk factors.

Okay, how do we treat otitis media? Decongestants, no. Antihistamines, no. They donít help otitis media at all. Now if youíve got somebody with a cold it doesnít hurt to give them a decongestant to help them open their nose, but itís not going to help their middle ear. If theyíve got allergies, you still want to treat their allergies. Itís just not going to help their middle ear. The Auralgan and Americaineís do not seem to work any better than placebos, but I know some people just canít get through the night without them. Itís okay. They are just hard to see through the next day. Antibiotics we think, most of the time, we still should be using them but I think thereís a place for not using them sometimes. Weíll talk about that. Analgesics, ibuprofen works better than Tylenol. Itís an antiinflammatory, it works better. Some people see a little worsening of pain just before it gets better because of shifting prostaglandins. If moms call and tell you, "Gee he got worse and then he got better" sheís probably telling the truth. The best way to treat this is to drain to abscess but most of us have not been trained to do that.

What shall we expect to happen? Well, we know that the gram-negatives in middle ears get better half the time, as long as you are not an otitis-prone person, all by themselves. But only 20% of the pneumococcus get better on their own. So pneumococcus, a harder bug to treat without drugs. We also know that if you pick the right drug and the patient takes the drug, and the bug is susceptible to the drug, 10% to 20% will fail and it has to do with antibiotics not penetrating into that little pocket of pus. Thereís no direct pipeline in there. It has got to soak in. If you think about this middle ear, full of pressure, full of pus, itís got to leak in amongst all those white cells and kill those bacteria, itís not unreasonable to expect that some people are not going to pump enough antibiotic in there. You pull away the antibiotic, it all starts up within four or five days. And we also know that there are no cures for recurrences. Like we talked about, three a year - okay. And weíd also like to keep people less than three months out of the year with an effusion, if possible, so that they develop their cognitive abilities okay. So these are expectations we would like to think about when we are trying to go after otitis media.

Middle ear fluid: this is where the battle is really fought. And if we can get drug in there it should work. Weíve got to be above the MIC-90, the amount of drug it takes to kill 90% of that strain of bacteria thatís in there. We talked about one-third of the time is enough for penicillins, half the time for cephalosporins, and more for those other drugs. So how we determine, how we apply that pharmacodynamic principle, we would like to have the serum concentration and the MIC to be in some sort of balance. What we want to have, and is probably not as clear to read on there, is we want one-fourth of the serum concentration has to be higher than the MIC-90. A round-about say of saying it is, that all eight times the MIC at the point of attack will get it done. Why is that important? Because, as you can see here, if we look at the blood levels as being 100%, the middle ear effusion on average has 25% to 40% when itís a penicillin or a cephalosporin. I think thatís one of those things youíve got to think about. If they bring you a new drug, how much gets in the middle year. If itís not over the MIC of at least eight times, youíve got a chance that itís not going to work and maybe you donít need to add that new drug. Maybe the old drugs will work as well.

I will not spend any time going over this in detail. This is my "Oh, my God" slide. What I want you to just take away from this is the second line here: amoxicillin, hereís the MIC for the intermediately resistant pneumococcus. Hereís the MIC-90 over, 8 to 16 for the highly resistant. You get 4 to 8 in middle ear effusion, so you can see why it should work against the relatively resistant, but not the highly resistant pneumococci. Now thatís at a dose of around 60 per kilo. If you go up to the 100 per kilo, you get a little more in there and we get a few of those lower end highly resistant ones. It kind of goes from the most potent all the way down to the less potent down here, where Ceclor on the bottom is actually the worst. Because it takes 64 to kill intermediates and you only get 2 to 4 in the middle ear, not terribly difficult math to do there to find out that we canít make this work. So if this is not going to work, then we shouldnít be using it for drug resistant pneumococcus. This is something to take home and just go over it for perusal. Maybe keep it around. If somebody brings you a new drug for otitis media, try to get this same kind of data and if you get enough in the middle ear effusion, in that column over there, to kill off these ones over here, then itís a reasonable drug to use.

This is why we like to think about how we can use amoxicillin b.i.d. now, and if that little line, that dotted one, thatís the old dose. Thatís the t.i.d. dosing and you had three of those little peaks going up during the day. If you look at the bottom line going across, that bottom black line, thatís the MIC-90 back in the 80ís. You can see we went above that line three times a day, weíd get you above it for at least 30% of the day and thatís why it worked. The reason it stopped working, late 80ís and 90ís, is because the MIC moved up to that second black line there and you can see that the time above the MIC for the dotted line is a very short time. Thatís why parents say, "Donít give me that amoxicillin stuff. It doesnít work anymore." At the old dose, they are absolutely correct. But if we take this new bigger dose, in that red box line there, is at twice the dose. Thatís at 60 per kilo, divided in two doses. Look at how much time it spends above the MIC, even if we use it just twice a day. So if we then were to think, "Letís go up to 100 per kilo, or 50 per kilo per dose" you then have a proportionately bigger curve. You can get above the MIC for more than 30% of the interval for most of those pneumococci, and thatís why amoxicillin b.i.d. works. Itís the time above the MIC. Weíve been able to compensate for it. People say, "How come we havenít been doing this forever?" Well, I guess we just werenít very smart back then and we didnít have bugs that were as hard to kill. We had to get pushed to extremes and pushing the system to the edge of the envelope to figure out exactly where we could use it in the most ideal fashion. For people who are worried about that 12 hours between doses, what did we used to think happened during the night when people went to bed a 8 oíclock and didnít take another dose until 7 in the morning? We had 12 hours between doses even on the t.i.d. regimen, most of the time. So this really isnít a dramatically different thing. We are just getting more drug to the point of attack and getting better coverage.

So microbiologists - hereís our primitive microbiologists using their old microscopes - trying to figure out whatís happened. Whatís happening with otitis media? Well, we pretty well know that we need to look at susceptibilities and if we try to take all the drugs and lump them together in to low, mid and high potency, we can kind of figure out where weíre going. In the box over there on the far right side you can see thereís lots of things that have high potency to kill regular old 80ís kind of pneumococci. The drug susceptible stuff. The weak sisters turn out to be cefixime, which is Suprax, Ceftibuten, which is Cedax, Bactrim which we know is recently slipping badly against pneumococcus, and ciprofloxacin. All the others work just fine and you donít really have a problem. If this was the only pneumococcus we had, we wouldnít have much the problems that we have right now. But if we put drug resistant pneumococcus on that same sort of sliding scale, a bunch of stuff falls way over here. Including: cefaclor, Ceclor, loracarbef which is Lorabid. Theyíve become weak sisters as well. Then weíve got the mid-potency stuff. A lot of stuff in the middle. Then we have the extra-potency drugs over there and amoxicillin clavulanic acid is only high potency if you get the amoxicillin dose up to about 60 to 100 per kilo. You see clindamycin plus sulfa, and actually levofloxacin is a little bit better than it looks on there, but not a whole lot better. It should be a little bit more over to the right. So not as many drugs to get drug resistant pneumococcus.

If we take H. influenza, one of the other pathogens thatís kind of hard to treat, the beta-lactamase producers, you can see thereís a lot that donít get beta-lactamase producing H. influenza and there are a lot that do. The ones that youíve really got to worry about here are clarithromycin, cefprozil, Ceclor and amoxicillin. But amoxicillin, as I said, shouldnít be used as a backup anyway. So I think thatís why itís still Ö because of its potency against drug susceptible pneumococcus, still allows it, if we put them all together, and make them whoís going to be the contenders, we can see that first line drugs: amoxicillin, Pediazole, and trimethoprim sulfa are still okay. If we could do those others - I mean, Ceftibuten, cefixime, clarithromycin - would all be reasonable first line drugs but they cost too much. If people fail those, then you would probably want to go farther to the right than you could, so I think using the amoxicillin clavulanic acid in the way I like to use it in kids, is give the 45 - they are high risk patients - 45 per kilo divided twice a day of the Augmentin. Just like it says in the PDR. Give them another prescription for 40 to 50 per kilo of amoxicillin and have them split that b.i.d. You take your dose of Augmentin followed by your dose of amoxicillin and that way you get your 80 to 100 per kilo of amoxicillin without having to buy extra Augmentin and you also donít increase the GI side effects. So you get sort of what we affectionately like to call, augmented Augmentin and thatís what gets you the best of both worlds. Youíve got beta-lactamase stability and youíve got the high dose of amoxicillin. If they are allergic to the penicillins, you can use clindamycin at 30 per kilo per day, divided t.i.d. and Gantrisin, 150 per kilo divided three times a day as sort of what I want to use as my big guns, if Iím allergic to penicillins.

This is just to tell us that previous antibiotic use, that daycare attendee who is less than two-years-of-age and anybody who has failed prophylaxis, are high risk for drug resistant pneumococcus. These are the ones that you really want to think about. If they have been in the ER and had Rocephin lately, as we call it, thatís also going to select for drug resistant pneumococcus. Remember winter and spring is worse than summer and fall. So if you remember Pogo from the old comic strips, "We have met the enemy and they is us", so what we would like to do is use less antibiotics. Like I say, thatís our new goal so we donít end up with egg all over our face.

A couple of quick things here. Just to show you the Cefuroxime, the drug does not absorb very well. The higher the MIC on pneumococcus the less activity. This isnít in your handout, but thereís 43% failures if they have a little bit higher rate. Of course Ceclor is 75% failure rate. Thatís kind of like placebo, as we all kind of know. If we were to take the penicillin drugs, the amoxicillin clavulanic acid, even with the higher MICís we are still getting good activity and that probably relates to absorbability and the fact that it is more bactericidal. Finally one of the things, the CRO, the red bars there. Thatís sort of the laboratory name for ceftriaxone and you can see ceftriaxone really isnít any better than Bactrim and is a little worse than amoxicillin-clavulanate, which is Augmentin, in treating low-risk patients with one dose. So itís about 80% effective and so thatís what you want to pass on to folks. If they want that shot, 80% effective as long as itís not drug resistant pneumococcus.

How long do we treat? I think thereís a place for no antibiotics. So the patients who come in and say, "I would rather not use antibiotics" - I think they donít want to be on antibiotics and I think if the patient has mild otitis, doesnít have a high fever, doesnít have a lot of ear pain, is not under two, is not in daycare, and itís okay with the folks, try masterful inactivity, as the Dutch have. Which is just ibuprofen. See if it gets better. If they arenít better in 48-72 hours, then you can apply your antibiotics. If they have bad GI symptoms I think you can give a does of ceftriaxone. If you are worried about drug resistant pneumococcus, the alternative to two more doses of ceftriaxone is give them seven days of high dose amoxicillin orally. So you stun them with the IM stuff and then give them the oral thereafter: in five days for people who have intermittent or low risk and are over three, and donít want to do without the antibiotics, five days works as well as ten if you donít have recalcitrant otitis. Then the people who are really problem cases, we still go ten days. Ten days is still the rule on those regardless of what people say.

Prophylaxis: Weíd rather have sulfa than amoxicillin because it turns out amoxicillin induces three times as many drug resistant pneumococcus. So Gantrisin, 50 to 75 per kilo. One dose at bedtime. Try to give it to them for six weeks then get them off. Donít put them on in the fall and wait until the tulips come up to get them off. Because you want to give them time to normalize their flora in between the vaccine. If they are over two, give them the regular pneumovaccine. It may help. Some times itís a miracle, some times it doesnít help at all. Itís worth a shot - no pun intended - for 30 bucks. The influenza - if they are otitis prone - give it to them in the fall. It will cut their otitis during flu season by half. We donít give immunoglobulin unless you prove they are deficient. And tubes - they break through and they go above your three rule and they go about three months for their effusion rule, thatís when they need PE tubes.