What happened to those pain-killing ear drops?

The Pediatric Insider

© 2017 Roy Benaroch, MD

MJ wrote in about her daughter. In the past, she used to use a prescription drop called Auralgan (benzocaine plus antipyrine) for ear pain, but it’s been taken off the market. What happened to it? Was it unsafe? Can she start buying it from Canada? What other options are there?

The FDA got tough on Auralgan and several other similar ear drops – AB Otic, Aurodex, Auroto, and other brands – in 2015. To my knowledge, there wasn’t any specific incident or allegation that these products caused any problems. But they’ve never been shown to be safe, and they’ve never been shown to be effective.

For many years these and other older “grandfathered” drugs were cheerfully sold alongside other prescriptions. But all new drug applications submitted to the FDA must include proof of both safety and effectiveness – that’s been the law since 1938, though what’s passed for “proof” has varied. Many older drugs, like these ear drops, slipped though when things were less stringent. But the FDA has always had the right to ask for more proof from the manufacturers.

I don’t really know why these drops got the FDA’s attention. It is true that there’s never been any proof of effectiveness. A German study cited in the non-discontinued products’ insert showed that children given Auralgan for earache did improve – but they didn’t compare the responses with a placebo, and we know that ear aches get better on their own, anyway. There was also a study from Pittsburgh in 1997 – the authors say they showed that topical Auralgan was “likely to provide additional relief” when given along with acetaminophen. But their study showed no statistical difference in pain scores at 3 of the 4 time periods, meaning that Auralgan was equivalent to their placebo (olive oil drops.)

There’s also no science reason to even think these drops would work. The two ingredients, benzocaine and antipyrine, are not effective when applied to the skin – they only work when injected or swallowed. Benzocaine has some activity when rubbed onto a mucus membrane, like on your tongue or gums, but that’s not what’s inside your ears. And: it makes absolutely no sense to use these to treat middle ear pain (like an ear infection, or the pain you get in an airplane), because drops in your ear canal don’t get into your middle ear. That’s like treating stomach pain by pulling on a finger. OK, bad example (ref: grandpa). Anyway, you get the idea.

Real Drugs are only supposed to be marketed in the USA with FDA approval, which requires proof of safety, effectiveness, and quality control manufacturing standards. For ear pain, if you want to stick with a Real Drug, acetaminophen is a pretty good choice. MJ asked about buying Auralgan from Canada – it looks like it’s still on the market up there. I found one place selling it for $142. That’s one expensive placebo.

Or, MJ could wander outside of the realm of Real Drugs. The 1997 study used olive oil as a placebo, and that’s safe – and you could use the leftovers in a salad. Or you could look in the alt-med, “alternative medicine” section of the drug store – there are ear drops there, but they’re not FDA regulated, so purveyors can sell whatever they’d like. You don’t know what you’re getting in those bottles, and there’s no reason to think they’d work any better than olive oil, pickle brine, or ranch dressing.

 

Parents can tell if an ear infection is getting better

The Pediatric Insider

© 2016 Roy Benaroch, MD

Good things come in small packages. A short, sweet letter to the editor in the November, 2016 edition of JAMA Pediatrics confirms that parents can tell whether their children are getting over an ear infection, with no doctor exam required.

The letter, from four Finnish physicians, is about a page long. It summarizes a small part of their data from a much larger study on the treatment of ear infections. In the letter, they’re only looking at 160 children, age 6 months to 3 years, who were initially treated for an ear infection without any antibiotics. Current guidelines from the US and many other countries do support treating less-severe ear infections with pain relievers only, waiting on antibiotics. But these guidelines suggest that if children with ear infections aren’t given antibiotics, they need to be followed closely and re-examined to make sure they’re really getting better. These authors asked, is that really necessary?

The 160 children were all reexamined for this study, and parents were also asked questions about whether they thought their children were improving, getting worse, or staying about the same. It turns out that among the children whose parents thought were getting better, only a very small number had worsening ear exams (less than 3%). Compare that with children thought to be getting worse – about 30% had worsening findings on their ear exams. Keep in mind that these were all children who did not receive any antibiotics. Presumably, if they had, even fewer of them would have gotten worse.

Parents, not surprisingly, were pretty good at judging whether their children were getting better. So good that based on these numbers, a repeat exam to make sure ear infections were clearing was probably unnecessary!

Caveats: I’d be a little more cautious with children at risk for prolonged ear infections or  persistent fluid behind the ears. Children with a history of difficult-to-treat ear infections should get a repeat exam, as should kids with hearing problems or developmental language delays—it’s crucial that those children get over their infections completely. But for the majority of children with ordinary ear infections that seem to be getting better, it may be reasonable to wait until their next check up to look at those ears again. Most of the time, parents’ judgment is just as good as a repeat ear exam.

 

Garlic for ear infections? Think again.

The Pediatric Insider

© 2016 Roy Benaroch, MD

Supermouse wanted to know:

One of my sons recently developed an ear infection, and various people have suggested sticking a clove of garlic in his ear, or garlic ear drops. Of course, we took him to the doctor who prescribed Amoxicillin, which worked quickly and well.

I have a hard time believing that garlic is a natural antibiotic that could be substituted for actual antibiotics. I could believe that garlic has antibiotic properties, but that shoving garlic in your ear (besides just being a bad idea to stick things in one’s ear) would be a poor way to access them.

So…does garlic have an antibiotic properties? Could it be used (in some form, drops into/onto the infection or eating it) to cure an infection?

First: does garlic have antibiotic properties? Can it kill or suppress the growth of bacteria? It makes sense that it would. Vegetables and other things that live and grow have evolved elaborate mechanisms to fight back against anything that wants to kill them. Armadillos have those hard shells, poison dart frogs have poison, and manatees have – well, I don’t know what they have, but considering that their natural predator is the speedboat, what they probably need is some kind of rocket harpoon. Plants, too, have elaborate defenses, like spikes on cactuses, or toxic chemicals that prevent them from getting eaten or infected with parasites and bacteria. Yes, your vegetables are literally loaded with toxins, including antibiotics. Elaborate chemical studies that have confirmed this – multiple substances in garlic do fight bacteria.

But does that mean garlic, placed in the ear, can help fight off an ear infection? Nope, it can’t. It’s a simple matter of anatomy. An “ear infection” – more properly called an “otitis media” – is an infection in the middle ear cavity, behind your eardrum. Unless you poke a garlic clove in far enough to pop the drum and push on through (do NOT do that), garlic placed in the ear cannot get to the site of the infection. Putting garlic in your ear to combat an ear infection is like putting oil next to your car engine for lubrication, or putting food near your mouth to eat it. To fight an infection, an antibiotic needs to be where the bacteria are. And an ear infection is internal, on the other side of your eardrum, where garlic or garlic oil pushed into the ear cannot reach.

But, and here’s the rub: if you put garlic in your child’s ear during an ear infection, will he get better? Probably yes. That’s because most ear infections get better on their own, without any antibiotic at all. You can stick garlic in the ear, or margarine, or a banana, or skinny Aunt Lulu – any of those might seem to work, but none of them will make any difference at all. Still, you’ll see it all over The Internets: I put garlic in an ear, and the infection got better, so yeah. Sorry. That doesn’t prove anything.

Side note: there’s another cause of ear pain, called a swimmer’s ear (or “otitis externa”). This is an infection of the ear canal itself, outside of the eardrum. Hypothetically garlic placed in the ear could reach that surface. But I wouldn’t recommend it. Swimmer’s ears hurt, and hurt bad, and pressing a garlic clove in there may make it hurt more.

Garlic steeped in olive oil sounds like a great spread for crostini, and it might keep vampires away. But it’s not going to help anyone with an ear infection.

The weekend ear pain action plan

New guidelines provide all you ever wanted to know about ear tubes. And more!

The Pediatric Insider

© 2013 Roy Benaroch, MD

The AmericanAcademy Otolaryngology – Head and Neck Surgery (AAO-HNS, often abbreviated “ENTs”) has come out with their official, evidence-based guide to one of the most common medical procedures in children: tympanostomy tubes, or “ear tubes”. It’s long, it’s detailed, and it’s well-referenced, and it ought to help guide ENTs, family docs, and pediatricians to help families make good decisions about who needs tubes, when they ought to be done, and how to take care of them.

The document includes solid background info on the health care burden of ear infections, and the risks and benefits of tubes. What I’m going to concentrate on here is the twelve “action” statements that they’ve come up with to guide health care decisions. All of these I’m paraphrasing from the statement—take a look there for references supporting these statements.

The first five statements are about children with what’s called “OME”, for “otitis media with effusion.” This is when there’s clear, uninfected fluid behind the eardrum. OME does not cause pain or fever or really other symptoms, though may be associated with some hearing loss. OME should not be treated with antibiotics—it is not an infection, and antibiotics will not help. It’s typically called “fluid in the ear” or “fluid behind the eardrum.”

1. Do not place tubes for uninfected fluid behind the eardrums (OME) of less than three months duration. Uninfected fluid just sits there and causes minimal symptoms (perhaps some blunted hearing), and it can be safely observed for at least 3 or more months before surgical intervention is even considered.

2. If fluid (OME) persists > 3 months, do a hearing test prior to surgery, or when surgery is considered. The reason to “fix” OME is to correct a possible hearing deficit; if there is no deficit, tubes are not generally needed. You have to check, first.

3. If there is fluid (OME) > 3 months plus hearing loss, consider placing tubes.

4. If there is fluid (OME) > 3 months plus other symptoms like school issues, balance problems, ear discomfort, or “reduced quality of life”, tubes can be considered as an option. This is not a recommendation—just an “option”, because there is very little evidence that tubes will fix these problems.

5. If fluid (OME) lasts > 3 months, it ought to be monitored at regular intervals to make sure hearing remains normal and that there are no other medical problems being caused by the fluid.

 

The next three statements are about “AOM”, or acute otitis media, defined by infected fluid behind the eardrum. It’s red, it’s bulging and distorted, and it causes ear pain and other symptoms. This is what’s commonly called an “ear infection”.

The statement defines “recurrent AOM” as 3 or more proven ear infections in the last 6 months, or 4 in the last 12 months (including at least 1 in the last 6 months.)

6. Clinicians should not place tubes for recurrent AOM if there is not fluid behind the ear at the time of the assessment. This is a little bit of a slap at pediatricians and the rest of us who diagnose ear infections—basically, it says that the ear specialist has to see for themselves that there is at least one infection before doing surgery. I agree with this. Ear infections can be tricky to see and are frequently over-diagnosed. If Junior isn’t really having ear infections, surgery is not going to help.

7. Ear tubes (in both ears) should be offered for recurrent AOM who have middle ear disease at the time of the evaluation. Note that “offer” is not a very strong recommendation—there is limited evidence that tubes help prevent AOM, and what evidence there is shows only a modest effect.

The next two statements refer to children who have special medical needs:

8. Clinicians ought to consider the big picture—including what children are at risk for further ear infections or developmental challenges related to hearing loss. Children with anatomic issues (eg, cleft lip), or baseline cognitive, developmental, or behavioral issues are at higher risk for complications from AOM, so may benefit from more-aggressive therapy.

9. In children “at risk” per statement 8, consider tubes when fluid lasts for three months or longer.

And, last, there are three miscellaneous statements:

10. Clinicians should teach families about tubes, especially about the expected duration of function, after-care, and potential for complications.

11. If there is drainage from tubes, it ought to be initially treated with eardrops instead of oral antibiotics.

12. Children with tubes should not be routinely discouraged from water sports, and need no routine ways to prevent water from getting into their ears. That means no earplugs, no headbands—just go swim and enjoy yourself.

So: a lot of information. The most important points are about fluid behind the eardrum. If it is uninfected, it can safely be monitored for at least three months before even considering tubes; even then, tubes really only should be pursued if there is hearing loss or a high probability of complications. If there is infected fluid behind the eardrums, tubes should only be considered if there are documented recurrent episodes, at least three in the last six months. And: ENTs and pediatricians ought to stop encouraging earplugs and water restrictions, because those measures do not help.

For those of you interested in the details, the full report is quite detailed and referenced—and can probably teach most physicians quite a bit about the best way to manage common ear problems. Tubes can help, sometimes, but they’re not always needed, and ought to be used only when they’re likely to help.

More about ears and infections:

The Earwax Manifesto

How many ear infections are too many?

How to prevent ear infections

The weekend ear pain action plan – what to do when your child’s ear hurts

To prevent ear infections, you have to prevent colds

The Pediatric Insider

© 2013 Roy Benaroch, MD

“My toddler keeps getting ear infections. There’s got to be a way to help with this. What can we do to prevent them?”

It’s frustrating, I know. Ear infections—doctors call them “otitis media”, because we need fancy-pants names for ordinary things—are very common, and account more antibiotic prescriptions than any other pediatric infection. Why do kids get so many of them?

If you stick your finger in your ear, it won’t go very far. Which is probably a good thing. If your finger were oddly thin and pointy, though, you’d be able to reach down your own ear canal to touch your eardrum (doctor-speak: “tympanic membrane”), a little flimsy sheet of tissue that closes off the end of the outer ear parts and separates the ear canal from the middle ear. Ordinarily, on the other side of the eardrum is a small, open, air-filled space through which sound waves can be transmitted with the help of three interlocking little bones.  The important thing to remember is that this middle ear cavity is sealed off on all sides, and is supposed to be filled with ordinary air. There is a little drainage tube on the bottom which can allow tiny droplets of normal mucus to drain out of the middle ear into the nose. All of this works pretty well, most of the time.

Until the drainage tube (doctor-talk, “Eustacian tube” or “Auditory tube”) gets clogged up. Then the middle ear space fills with nice warm mucus. That sits there. And you can guess what happens: bacteria love warm, stagnant mucus. Party time = infection in the middle ear = Mommy, my ear hurts!

What causes congestion that clogs up the drainage tube? Usually, a common cold virus. Junior gets the dreaded yuck, gets all snotty, the tube clogs, and normal mucus can’t drain. That leads to ear infections.

Little kids get far more ear infections than adults. They get far more colds, especially if they’re enrolled in group care. They’re not very good at blowing their little noses and clearing out mucus. But most importantly, that drainage tube of theirs is oriented horizontally, and it’s thin—the net effect being, it doesn’t drain well. They’ve basically got lousy gutters, and the mucus builds up behind them, especially when there’s a lot of snot around.

Ear infections do run in families, probably because some families tend to have even worse middle ear anatomy that predisposes to more infections. Parental smoking is also a big-time contributor to ear infections, because that contributes to chronic congestion and poor drainage. Sometimes, chronic nasal allergy causes nasal congestion, poor drainage, and at least some ear infections. But by far, the biggest contributor to ear infections are ordinary common cold viruses. In fact, during an ordinary cold young children will develop an ear infection about half of the time.

So what can be done to prevent ear infections? The only really practical strategies are to try to prevent the spread of cold viruses:

• Avoid group care, if possible
• Stress the importance of handwashing
• Practice good cough and sneeze hygiene—we should cough into our elbows, not our hands!

In addition, try to avoid second-hand smoke, and make sure that your children are up-to-date on their immunizations. Though there is no one immunization that will prevent all or even most ear infections, some infections can be prevented by making sure that your child has had the pneumococcal conjugate and influenza vaccines.

Related posts:

Weekend ear pain action plan—you do NOT have to rush to the ER, but you ought to help your child feel better when there’s a suspected ear infection

How many ear infections are too many?

Diagnosing ear infections requires an exam

What to do if your child seems to get too many colds

How to help your pediatrician examine your child’s ears

The Pediatric Insider

© 2012 Roy Benaroch, MD

Let me tell you a secret: Examining eardrums in a squirming, angry child is really difficult—if not impossible. If the doc in your screaming, struggling child’s ear for a half-second, it’s unlikely that anything useful was seen.

Sometimes, it is just impossible to get a decent exam. But there are ways that parents (and doctors!) can help at least increase the chance that we can get a good look.

First, work together to help keep the child relaxed. No one should rush, and no one should immediately start holding anyone down. The minimum hold is best—more of a reassuring hug than a hold, really. And even before that, I like to give toddlers a chance to look in my ears, and mom’s ears, and their teddy bears ears. Look look look, and practice first. Parents can even buy a cheapo otoscope to practice with at home, on themselves and kids and plastic dinosaurs. If it has ears (of even if it doesn’t), Junior should practice looking in them and telling stories about what they see.

About stories: I used to see monkeys in ears, and over the years the monkey stories have gotten more and more elaborate. Now the monkeys are opening presents and eating lunch and watching movies. I’ve found if I tell kids what the monkeys are up to, in a quiet but excited voice, they sometimes hold very still to see what will happen next.

Don’t even think about saying the word “hurt.” That word ought to be banned from pediatrician’s offices forever. You might say “This won’t hurt,” but I guarantee all the child hears is “HURT PAIN HURT HURT PAIN”.  Another thing not to say: “He hates having his ears examined.” I already knew that. Thanks for reminding us.

Children of every age pick up on the mood of the parent and doctor. Calm, confident, secure—that’s the way to go. Don’t fret or apologize or wave toys at the child. Even if you think things won’t go well or aren’t going well, pretend that they are.

About earwax: It’s natural, it’s normal, everyone has some, and some kids have more than others. Parents are not at fault if Junior has earwax that’s blocking the view. To help keep wax at bay, wash ears with a soapy washcloth, and be sure to rinse the ear canals gently afterwards. Don’t use Q-tips or swabs—those just pack the wax tighter and push it farther in. More details about earwax control, here.

Some kids find ear-looks (and doctor visits) more worrisome than others, just like some parents and some doctors are more worried or rushed than others. Some visits don’t go well, but there are always ways that we can all try to make the next visit better. I, personally, find it very satisfying to get a good, tear-free ear look in a child—bonus points for a smile!

Antibiotics may do more harm than good

The Pediatric Insider

© 2012 Roy Benaroch, MD

Add to the growing list of reasons antibiotics might not be good for you and your children: a recent study showing a statistical link between early ear infections and inflammatory bowel disease (IBD).

Researchers in the UK analyzed data from about a million children, looking specifically at the 750 who developed IBD (Crohn Disease and ulcerative colitis, mostly.) They then compared the kids with IBD to children without that diagnosis, and looked back at the frequency of prior ear infections. Ear infections are the most common diagnosis leading to the use of antibiotics in young children, so it was figured that more ear infection diagnoses were a good marker for more antibiotics.

Their analysis found that early ear infections increased the risk of IDB substantially, probably by about 80%. The highest risk was among children with the most ear infections, and among children with the earliest diagnoses. So more antibiotics, and earlier antibiotics, seem to be predictive of the later development of IBD.

IBD is a complex illness. It seems to be related to altered immune regulation in the gut and other tissues. It’s been speculated that the normal bacteria in the gut help with the early formation and control of the immune system.  Early antibiotics could indeed interfere with that process, and are a plausible trigger for IBD, at least in people who are genetically predisposed. There are probably other factors at work, too.

Indiscriminate antibiotic use is bad news. It contributes to the development of resistant superbugs, and may play a role in the development of obesity, allergic disease, and asthma. Insidious forces can sometimes encourage the perceived “quick fix” of an antibiotic prescription—including rushed doctors, exasperated parents, and a health care system that rewards “satisfaction” over health. If you want to protect your child from unnecessary antibiotics, you have to ask a few questions:

• Is this antibiotic really necessary?
• Are there other options?
• Is it safe to wait?
• If we do need an antibiotic, what’s the safest one to use?

And, of course, remember that prevention is always better than cure. Keeping your child up to date on vaccines—including influenza vaccination—prevents both bacterial infections and some viral infections that predispose to ear infections and other antibiotic temptations. Nursing, avoiding group care, avoiding second-hand smoke, and not bottle-propping—all of these can help prevent at least some ear and other infections.

There will be times when an antibiotic is a good idea—I don’t want parents to be afraid of them when they really are necessary. But parents and doctors both need to take an active, thoughtful role in deciding when antibiotics are really a good idea.

“What the heck are adenoids, and why does the doctor want to remove them?”

The Pediatric Insider

© 2011 Roy Benaroch, MD

Let’s get this one thing straight first: you’ve only got one adenoid. I don’t know why it’s referred to in plural, but let’s put a stop to that right now. Just one. Adenoid.

Your adenoid is a blobby sort of tissue, way back behind your nose. Want to touch it? Just stick your finger waaaaaaay up your nose, back about as far as you’d have to reach to touch the back of your throat. Go ahead, try. (Better yet, don’t. I was kidding. Do not sue the nice doctor.) I’ll bet you never even thought your nasal cavity went back that far. Kind of cool. All the way back there, hanging off the back wall of your nasal cavity, sort of right in the middle of your head, is a little fleshy blob, the adenoid. It can’t be seen directly, but an ENT (ear, nose, and throat) specialist can snake a little scope up the nose to get a peek, or get an indirect view with an x-ray.

What’s it for? It’s made of the same kind of tissue as tonsils, so it presumably has something to do with the immune system. Like tonsils, it probably does its job very early in life, or even before birth. Removal of either tonsils or the adenoid in children does not seem to lead to any increased risk of infection—so basically, at least once your children are a year or so old, the adenoid doesn’t seem to do anything useful at all.

In fact, sometimes the dang thing just kind of gets in the way. The most common reason for removal of the adenoid is that it gets too big in some children, and dangles into the back of the nose. This makes it hard to breathe. During the day, kids with a huge adenoid often breathe through their mouths. It gets worse at night—when the muscles of the face and mouth relax, that big honking adenoid can drop down and cause loud snoring, interrupted breathing, and sleep apnea. This leads to fragmented, poor quality sleep, and sometimes grumpy kids and parents. Worse, chronic poor sleep can affect school performance, and can eventually cause permanent damage to the lungs and heart. Bad news. If your child has symptoms of trouble breathing at night or loud snoring (the kind you can hear from another room), you need to talk with the pediatrician about a referral for evaluation of both tonsils and the adenoid.

Another common reason to consider removal of the adenoid is to prevent ear infections. The adenoid is located right near the auditory (or “Eustacian”) tube, a connection to the middle ear. Some kids with recurrent ear infections are being re-infected by bacteria that hide on the knobby surface of the adenoid. The large adenoid may also at times physically clog up that auditory tube, preventing drainage of mucus from the middle ear—and that further increases the risk of infection. Removal of the adenoid does lead to fewer ear infections, and should be considered especially in children who’ve already tried more-conservative measures.

A little more controversial is the role of the adenoids in recurring sinus infections. Again, the knobby tissue itself may be chronically infected, which might serve as a “hiding place” for bacteria, allowing them to sneak back into the sinuses even after an infection is successfully treated. There’s also some evidence that chronic inflammation of the adenoid might lead to swelling and inflammation of the sinuses, which prevents good drainage and further contributes to infection. Studies of the effect of removing adenoids from children with recurrent sinusitis haven’t been super-impressive, but the procedure does seem to help at least some children. Recurring sinusitis can be a complex problem, and I don’t think there is a one-size-fits-all approach. Adenoid evaluation and removal is probably a good option in some cases.

If surgical removal is needed, it’s a pretty straightforward procedure with a short recovery in children. Sometimes removal of the adenoids is combined with tonsillectomy and maybe ear tubes as well, sort of an ENT trifecta. Work with your ENT to decide on the best approach to your child’s situation, and feel free to ask for a discount—especially if you already took the trouble to reach back there yourself. I said I was kidding!

Thanks to ace ENT Julie Zweig, MD of Northeast Atlanta ENT in Johns Creek and Lawrenceville for her help reviewing this article.

 

EDIT (12/16/2013): When reviewing this article, I don’t think I did a good job explaining that there are risks to adenoid surgery (as with any surgery.) Though the procedure is, as I said, “pretty straightforward with a short recovery”, there is a small but real risk of complications. The rate of complications is much higher when adenoidectomy is combined with removal of the tonsils.

 

 

 

How many ear infections are too many?

Aamnda in the topics thread asked, “What is a reasonable amount of ear infections a child should have in a year’s time span before parents should see an ENT or ask their pediatrician about tubes?”

There isn’t a one-size-fits-all answer, but I can tell you there are things that you and your doctor should look at that will influence this decision.