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The Buzzy: Revolutionary Acute Pain Management or Simple Distraction…

Buzzy

I’ve written about the management of acute pain in children in the past, and unfortunately my feelings haven’t changed in the interim. Acute pain, particularly pain related to procedures such as venipuncture for blood sampling and intravenous access, and intramuscular administration of medications such as antibiotics and vaccines, is commonly undertreated, downplayed and even ignored altogether by medical professionals and even caregivers. So when I was made aware of a device being used in pediatric clinics and emergency departments (and even available for home use) with apparent success in preventing or reducing procedural pain in children, I was intrigued and more than a bit hopeful.

The device in question, known as the Buzzy, is touted by the manufacturer as an all-natural and seemingly miraculous device. I’ve put a few words/phrases in bold to highlight what I want to discuss later:

Invented by a pediatrician and pain researcher, Buzzy is a reusable breakthrough personal pain device that provides natural pain relief. Gate control is the basis for Buzzy, physiologically overwhelming the body’s pain nerves with benign cold (ice wings) and vibration (Buzzy’s body). Like a dentist jiggling a jaw or putting a burned finger under cool water, cold and vibration dull or eliminate sharp pain from shots, itching, or burning from medications. Independently verified research shows Buzzy works!

I was asked by my department to look into the effectiveness of the Buzzy, and to help decide if purchasing these devices and putting them into use in our clinics and emergency department was worthwhile. According to the product website, the Buzzy is already in wide use. And there are numerous testimonials provided by satisfied customers, even from some using the device for reasons unrelated to blood draws or shots such as itching or dental cleaning. It’s even won awards for its design.

Buzzy for Aches, Arthritis, and Injuries
Buzzy for Allergies and Itching
Buzzy for Botox, Dermatology and Cosmetic Procedures
Buzzy for Injections
Buzzy for Lab Draws/Phlebotomy
Buzzy for Vaccines

Funded by a 1.1M NIH SBIR grant, multiple studies show Buzzy® significantly decreases phlebotomy pain in adults and in children. Not only did Buzzy® significantly decrease pain by child and parent report, IV success increased three times on the first try! Healthcare professionals use Buzzy® for diabetes, dentistry, travel immunizations, fertility shots, finger testing, splinter removal, flu injections and more! Over 1200 hospitals and more than 36,000 users have adopted Buzzy®. Buzzy® was a 2011 Medical Design Excellence Awards recipient and Top 10 Innovative Technology Company in 2012.

Well, if it didn’t come across as a little too good to be true I probably wouldn’t be writing this post, would I? And while looking into this product, I found more than just well-intentioned excitement that outpaces the available evidence. My journey also led to the discovery of some nice examples of how information can be manipulated to sell a product.

What is the Buzzy and how is it used?

As seen in the accompanying picture, the Buzzy is designed to look like a bumblebee, which is admittedly cute. Its body vibrates vigorously when activated and its detachable wings are soft plastic pouches containing a freezable gel. The Buzzy functions primarily in two ways in order to maximize its ability to take advantage of the gate control theory of pain, according to the manufacturer. The cold gel numbs the area of needle insertion for 30-60 seconds; however, they recommend moving the device 3-5 cm proximal to the expected sharp pain to allow the vibration to “confuse the nerves and interrupt pain pathways to the brain.”

Claiming the same proposed mechanism of action, the product website gives information on a variety of indications where the Buzzy could be helpful in addition to just blood draws and intramuscular shots. They state that distracting pain fibers as they travel to the brain from the site of insult can help with itching, such as with eczema or when performing allergy testing, intraoral injections and cleaning at the dentist’s office, removing splinters from a finger, daily diabetes care, wound cleaning and insect bites and stings. A lack of reasonable supporting evidence doesn’t appear to be required before touting a benefit, as the following example from the page on use of the Buzzy for allergy testing shows.

Buzzy won’t stop sneezing, but he can be very helpful for kids itching from allergies or adults who don’t like shots. Since pain and itching pass on the same nerves, Buzzy can relieve eczema itching as well.

Rubbing and cold have long been effective to reduce itching. For eczema itching, put the ice wings under Buzzy’s elastic strap and rub Buzzy where the itching is. Buzzy can provide a few minutes of relief while you wait for creams or medications to kick in.

Followed by

N of 1 (Volunteer Miles, potentially biased son of Dr. Amy):
Itching was relieved after 7 seconds when Buzzy was used with ice pack. Itching was relieved after 12 seconds when used with vibration alone. Buzzy was more effective when pressed in place at the top of the spine, but was not as effective when simply lying on the back as in the picture. After removing Buzzy, the itching returned after 17 seconds following the buzzy-plus-ice wing trials, and after 13 seconds following the vibration only trials.

That’s the evidence base for use of this device for itching. Aside from the fact that the above anecdote is worthless, did you pick up on the glaring potential confounding variable? Buzzy helps relieve eczema by rubbing the itching area of skin. I wonder if there would be a difference between using the Buzzy and say your own hand in this regard.

The manufacturers make many additional claims of potential benefit for the device, all of which are attributed to “unsolicited testimonials.” These include reducing pain with breastfeeding and dermatological procedures, in addition to pain from arthritis and musculoskeletal injuries, if you need a few more examples. I can’t help but start to think of the Buzzy as the “one true cure” for acute pain, which isn’t the complement it may sound like.

What is the gate control theory of pain?

The Buzzy is claimed to work primarily not by simple numbing of the skin with cold and distraction from pain, but by taking advantage of modulatory mechanisms. This gate control theory, first proposed in the 1960s, is widely accepted by neuroscientists and pain experts even if there is still some debate over the exact mechanism behind it. With gate control, a typically non-painful stimulus “closes the gates to painful input”, which reduces CNS awareness and dulls the sensation of pain.

The fine details aren’t entirely understood, but the accepted general thinking is that pain fibers in the peripheral nervous system exist in a state of inhibition until injury occurs. With tissue injury, a pain signal travels towards the spinal cord and ultimately to the brain, in the process inhibiting the inhibition from interneurons. When mechanoreceptors in the skin are stimulated, such as when you rub a sore elbow, the inhibitory interneurons are activated which decreases our sensation of pain.

Gate theory also helps to explain the development of chronic pain even after tissue injury has resolved. Modulation of pain fibers and altering our normal state of pain inhibition, perhaps in part with the prolonged use of opioid medications, can lead to the sensation of pain seemingly without a cause. Phantom limb pain as well as transcutaneous electrical nerve stimulation (TENS) are examples of the dueling nature of gate control theory.

Does the Buzzy work?

Before I get into the evidence base for this device, I wanted to dig a little deeper into its marketing.

Being invented by a pediatrician, even one who is a pain researcher, is an appeal to authority in the same vein as Airborne being invented by a teacher. Sure it is true that most pediatricians are very interested in reducing pain in their patient population, but typical pediatric training in no way establishes us as experts on the mechanisms of pain or on its treatment. In this case the inventor, Dr. Amy Baxter, is an accomplished physician who completed a residency in pediatrics and fellowships in child abuse and emergency medicine. She is involved in research, some of which is on the recognition and treatment of acute pain in an emergency department setting. As a pediatric emergency medicine practitioner she certainly sees more than her fair share of children in pain, but this, and her clinical research, don’t serve as evidence in support of the Buzzy’s efficacy.

According to a More magazine article on Dr. Baxter and her now million-dollar device, the idea for the Buzzy came when she noticed that her hands felt numb after driving a car with misaligned wheels and a vibrating steering column. Upon arriving home, and with the assistance of a bag of frozen peas, a black and yellow personal massage device and her son, she tested her hypothesis that the skin under and distal to an application of cold and vibration would be less sensitive to pain. Sure enough, her child’s skin was numb to a hard pinch and her creative husband even helped by decorating the massager like a bumblebee. It’s a cute story, it really is. An article written just a few months earlier included the same genesis story, although some of the details were different. That doesn’t mean the story was made up, but it is a good example of how our memories are often changed over time and with numerous recollections.

Dr. Baxter lists being a Scholar (delegate?) at the Washington, D.C. TEDMED conference in 2013 on her resume, which means that her registration application was accepted and she could pay the upwards of $5,000 to attend the for-profit organization’s yearly conference. TED is a non-profit organization by the way. They do offer a limited number of need-based partial scholarships, which is perhaps why she wrote scholar instead of simply delegate, but she was not invited to speak. Regardless, I imagine that this was a very meaningful networking experience and it looks great on a resume (too cynical?).

I did however come across a talk she gave at a TEDx event in Georgia in 2013. As readers likely already know, TEDx is not burdened with the same level of quality control as its parent organization TED. This, in my opinion, is a good example of that sad fact as her talk is essentially a commercial for her product. While I agree wholeheartedly with the call to take pediatric pain seriously, she makes a number of unproven assumptions while discussing the potential negative impact of poorly treated pediatric pain.

She educates the crowd on the significant increase in the number of childhood immunizations over the past few decades, which is true, but she blames this for a rise in “severe needle phobia”, which is controversial. It is unclear if more children are truly needle phobic, as she describes her own child as being, or whether the children being labeled as such are simply expressing normal avoidance behavior. Her message comes across as if prior to the Buzzy there were no means of effectively reducing procedural pain and anxiety related to shots, although again I admit that these proven techniques are too-often underutilized.

She goes on to equate the rise in needle phobia to decreasing vaccination rates. There is no evidence that I could find that pediatric needle phobia plays a significant role in vaccine hesitancy or refusal, and her logic is convoluted. She claims that fear of harm from vaccines, such as the development of autism, might just be a rationalization used by parents who really just don’t want their child to experience the pain of multiple shots. As if that’s not enough, she questions whether these needle-phobic children will grow up to become adults who avoid routine medical care and treatment, describing needle phobia as a “public health tsunami that is going to crush us.”

She absolutely comes across as a genuinely caring person and a supporter of vaccines, although she did slip in a comment supportive of spreading vaccines out. She didn’t go into any detail but there is no good evidence to support changing the recommended vaccine schedule and this would leave more children at risk of vaccine-preventable illnesses, even if only for a short time. I do agree with her that it would be great if we were able to administer more vaccines per shot (there are some combination vaccines available already). I do not get the impression that this was a calculated attempt to promote her product, but she sure didn’t mention any other method to reduce or prevent pain in kids.

Many of the posts at SBM have pointed out the fallacy of appealing to nature. This is the argument that a treatment is good simply because it is natural. Consequent to this is the implication, if not outright claim, that when something is unnatural or synthetic it is inherently bad.

Proponents of many unscientific modalities are quick to label drugs as dangerous products of heartless pharmaceutical companies while natural herbs, for one example, are beneficial creations with no associated risk. Chiropractic is natural. So are homeopathy and acupuncture for that matter. The Naturopaths even put it in their name. And companies too numerous to list have employed shady marketing strategies to take advantage of the appeal to nature. Probably the vast majority of these products have little to offer in the way of true efficacy.

Unfortunately reality doesn’t work like this. Nature has certainly given us a variety of medically useful chemical compounds, of which we’ve harvested much of the low hanging fruit. But it has also given us potent toxins, carcinogens and a seemingly endless supply of chemicals that are unsafe for consumption or therapeutic use. The Buzzy is touted as providing “natural pain relief.” So do “poppy tears” and biting on a leather strap. I’ll accept that using the device is safe, although the question has been raised of its potential impact on some test results (Dr. Baxter’s response, which I agree with), but does it work? And not only does it work, does it work better than already established methods?

To truly know if the Buzzy works, it would need to be studied in a controlled and blinded fashion. It would need to be studied in sufficiently large numbers of children as well. And we would need to take the prior plausibility of the claimed benefits into account.

Thankfully, the product website provides a comprehensive list of the available research on the Buzzy. Before we look at it, I’ll go ahead and say that I think that there is reasonable plausibility that the Buzzy would have a positive impact on the perception of mild to moderate episodes of acute pain. Whether by simple distraction or via gate control, I think it could help. And if proven effective, the question of whether it works better than cheaper, widely available methods would remain.

First off, their research page is confusing. It lists 8 items, numbered 1-5, 5, 5 and 5. Upon closer inspection, only five of the items are published papers in peer-reviewed journals. The additional three items consist of repeating one of the first five papers twice and one presentation at a trauma symposium of a small unblinded, uncontrolled and nonrandomized compilation of 100 emergency department patients. It showed that the Buzzy decreased pain compared to no pain control intervention.

Study #1 – Looked at use of the Buzzy AND local anesthetic for monthly penicillin injections in patients with rheumatic fever. It was unblinded and only half of the subjects responded to the survey. Patients who used both interventions reported less pain and fear than those who just got the anesthetic with their injection. Maybe the Buzzy helped or maybe it was simple distraction by a novel intervention or a host of other placebo effects.

Study #2 – This study involved 120 6-12 year old children. It was unblinded but randomized, with some using the Buzzy and others normal phlebotomy. Those using the Buzzy were rated as having less pain and anxiety by the staff and parents. Again, simple distraction could account for this difference. It can think of an easy way to test this. Just don’t turn the buzzy on in half the kids and don’t freeze the wings.

Study #3 – This study, done by the same researchers in #2, involved 120 6-12 year old children. It was unblinded but randomized, with some using distraction cards and others normal phlebotomy. Kids using distraction cards had less pain and anxiety than those not being distracted. I’m not sure why this was included as evidence that the Buzzy works as it supports use of distraction. The cards do not vibrate.

The lead author for the following two studies was Dr. Amy Baxter, the inventor of the Buzzy. That fact alone should not disqualify them but you should know that.

Study #4 – 81 children aged 4-18 years were randomized to either the Buzzy plus routine care (half got topical anesthetic and 9 got vapocoolant spray) or routine care alone, which involved placement of a topical anesthetic in about 50% and use of vapocoolant spray in all but 2, for IV placements and blood draws. It looked at self and parent assessment of pain (unblinded) and assessment of behavior on video by unblinded reviewers and showed that use of the Buzzy helped. But it wasn’t blinded and there was no placebo control. I honestly am surprised this paper was accepted considering it appears designed to be positive and serves as an advertisement for the product.

Study #5 – Older study and in adults. Unblinded. No placebo control. Only 30 subjects. Results not clinically significant.

The website lists ongoing trials involving the use of the Buzzy for influenza vaccination, dental pain and eyelid injections.

That’s it. There is no evidence provided for any of the numerous additional claimed on the website.

Conclusion

Appropriate management of pain in the pediatric population is important for a number of reasons, not the least of which being that it’s just cruel to let a child feel pain or suffer when it can be avoided or ameliorated. While I don’t agree with the more alarmist and hyperbolic concerns raised by the inventor of the Buzzy regarding poor prevention and treatment of pain in children, it is true that untreated pain does potentially lead to problems down the road. Untreated pain, whether it is in a neonate or an adult, can alter the way our bodies experience pain in the future. And it could lead to an impaired relationship between an individual child and the medical system, just not with such far-reaching implications as claimed by Dr. Baxter.

The Buzzy probably does have some utility. I’m not surprised at all that so many people, according to the manufacturers, are pleased with the results. Cold can desensitize the skin somewhat. And vibration might help via gate control of pain sensation. But the evidence provided doesn’t support a claim that this device works via that specific mechanism or any better than simple distraction techniques. If the Buzzy works via a mechanism other than distraction, it should have some benefit in populations where placebo effects, although still present, might have less influence on outcomes. Neonates for instance. While this study only looks at vibration alone for reducing neonatal heel stick pain, and suffers from similar limitations, it was interesting.

Many pediatric facilities employ a variety of distraction techniques that can be very effective. Some have at their disposal child life specialists who are experts in helping children get through painful procedures, in addition to many other very useful skills. The problem isn’t that what they do doesn’t make a difference. The problem is that many painful procedures involving children take place in facilities without child life specialists available. And in many of the more adult-oriented facilities, painful procedures are performed with no effort given to pain prevention and treatment. The notion that kids should just suck it up is unfortunately still alive and well.

The Buzzy might serve as an effective means of distraction, particularly in younger children (they recommend age 4 years and up), and it only costs about $40 per device, which is pretty cheap. And it is incredibly safe as far as medical interventions go. So if a parent wants to buy one for home use, I certainly wouldn’t have a problem with that. And I could see the benefit of a non-pediatric facility using these devices. They do appear to be better than nothing and having some around might help encourage staff to take mild to moderate procedural pain more seriously. But for pediatric facilities that already have available distraction resources, especially if there is a child life specialist available, and who already have a focus on proper pain management in kids, it is probably a waste of money.

Posted in: Science and Medicine

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57 thoughts on “The Buzzy: Revolutionary Acute Pain Management or Simple Distraction…

  1. nutrition prof says:

    When I was a kid, my pediatrician used to pinch my arm before giving me a shot. I’d cry from the pinch…not the shot. Sounds kinda natural. Of course, the candy afterwards made everything better.

  2. goodnightirene says:

    None of my four offspring ever cried or fussed about a shot, except possibly in infancy, and then only briefly. Two of my boys never even made a peep when they had stitches–which astonished me. Today I see kids wailing and thrashing about (literally) when they trip and stumble at the mall.

    I think it’s cultural–much like the obesity epidemic.

    I just checked with my kids who are parents and only one of six grandkids fusses (a bit) about shots–the same one who cries a lot about many other insignificant things. We call her “sensitive” and she is very sweet and loving.

    Just my family, to be sure, but my point is that it’s attitudes that have changed, not pain levels.

    1. goodnightirene says:

      I’d like to add that when I was a child and my parents had actually seen polio and my mother had actually (barely) survived diphtheria, nobody worried about needle phobia or cared if you cried when stuck. We were lined up in the school cafeteria which was filled with long tables and a dozen Nurse Ratchets who grabbed your arm and stuck you without a word or a smile, let alone a Buzzy contraption. I guess it’s cute, but my kids were a lot more afraid of a bee than a shot.

      That said, I’m happy the Buzzy helps out with the kids who have cancer. Thanks for that comment Missmolly!

      1. Missmolly says:

        Totally agree that loads of kids struggle with being resilient these days- a little one whose parents exclaim ‘yay! Look how well you bounce!’ when they take a little tumble is going to be able to deal with the vicissitudes of life (including the occasional needle) much better than one whose parents scream, wail, clutch them to their bosoms and fly for the ED at the smallest scraped knee! Buzzy bees cannot replace parental common sense and the loving resilience-building you have clearly showered on your kids :)
        But when they’re going to have to endure 3 years of regular sticking as a kid with ALL, it sure does feel nice as a dr to give them a bit of a break! Actually, maybe that’s part of the key: the dr is more relaxed knowing there’s some amelioration of the pain they’re about to cause, and so passes less stress on to the kid. I wonder if you can blind for that?

    2. Calli Arcale says:

      I wouldn’t be so quick to believe it’s cultural or that modern kids are wussier about shots; we are too prone to glamorizing our own childhoods for me to not see any statement along those lines without a bit of suspicion. There’s also the myriad problems of anecdotal evidence. It’s possible your bloodline is less sensitive to pain in the first place, so your genes are the advantage and not your parenting.

      To throw out another useless N of 1, my mother (born in 1951) was so afraid of needles that on one occasion, after the needle was in her bicep she tensed so hard the needle snapped. I suspect people vary far too widely in their sentiments about needles for any useful correlations to be drawn from just personal experience.

      1. Gerry Beggs says:

        Being afraid of a needle is different than experiencing pain from a needle.
        Your mother’s experience was due to her anxiety, not from the pain.

        Whatever pain is experienced from needles is minimal… less than a pinch. The fact that people freak out and cry when they need to have a needle shows that the pain is not the problem. It’s that they have learned to be afraid of the needle.

  3. Exie says:

    Thanks Clay for this information! I was just looking into this product a bit, as I just returned to work at the hospital in La you use to work at. Last week was Magnet survey and there was a large poster of “research” on the buzzy! I was interested then quite skeptical when I saw what it was. Thanks for the clarification and info!

    1. Clay Jones says:

      Hey Exie, glad to hear from you. I don’t think it would add much there as they have child life available and I think they did an okay job in general with this kind of thing. The main issue I always had was with the surgeons coming through and pulling packing, sticking needles in things, etc. etc, with no warning to nursing and no chance for any pain control.

  4. James says:

    Thank you for this post.
    This got me thinking about how my wife and I can distract our daughter while doing her hair.

  5. Harriet Hall says:

    Instead of fearing an increase in needle phobia if blood draws and immunizations are done without pain relief, I wonder whether using a device like Buzzy might increase needle phobia by reinforcing the idea that those procedures are so painful that they require special pain relief treatments. They are usually not. My kids didn’t cry with shots. As an adult, I would personally reject any pre-treatment for blood draws and shots as unnecessary and time-consuming. I wonder if some kids develop needle phobia because they were surprised by a pain they didn’t expect. They may even feel betrayed by their parents and doctors. Perhaps a more matter-of-fact approach would be better: “This is to help keep you healthy; you’ll feel a tiny pinprick but it will only last for a second.”

    I can see a potential use for Buzzy with a severely needle phobic child; but I suspect other kinds of suggestion and distraction would work just as well with less expense. But the bee is cute, isn’t he?

    1. Jessica S says:

      “Perhaps a more matter-of-fact approach would be better: “This is to help keep you healthy; you’ll feel a tiny pinprick but it will only last for a second.””

      This is the approach I take with my three and a half year old. I capitalize on how much he hates “gagging” (his word for throwing up) and tell him it keeps him from gagging. I don’t really address the pain unless he mentions it, and then I might say “oh, I don’t know – maybe it pinches for a second but then it’s over and you get a bandaid!”

    2. Harriet makes a lot of sense here (as usual). I don’t have kids of my own, but I do spend a lot of time with my friends’ children, and I see similar situations with kisses and band aids. I see some children who often freak out at any ouchie and won’t stop freaking out until they get a kiss on the booboo or a band aid, even if there’s no bleeding or broken skin, but are instantly calmed when the kiss &/or band aid are applied to the ouchie. It seems the parents have inadvertently conditioned the children that the kisses on the booboos &/or band aids are require for all ouchies.

  6. Amy Baxter says:

    Wow, Clay! Impressive research – I think your work is comprehensive and very fair. A few general points: Buzzy simply combines two modalities for relieving pain: cooling and massage. Both are FDA Class I minimal risk modalities of making minor aches and pains better. Buzzy isn’t rocket science, but my idea was novel enough to get a few patents. I often say that if you’re hurting, feel free to get a massager and cold pack and put them together. However, having one device that curves with cold and motion together is convenient. In addition to the studies you mention, there are two new studies by Whelan HM et al (Clin Peds) and Canbulat N et al (Pain Nursing) that show clinically decreased pain with Buzzy, both for IV accesss. Studies are completed or underway comparing Buzzy to LMX, injected lidocaine, and as a modality for propofol infusion. I have nothing to do with any of these studies, and the ones I published were proof of concept for my idea done with NIH conflict of interest standards in place. I didn’t do the analysis or data collection.

    My TEDx was very intentionally NOT a sales pitch for Buzzy: as I say several times on my website, Buzzy doesn’t work as well for young children. The ice is too cold, and what we found was that the simple number of shots is what overwhelms children. I was vague in the TEDx because part of our NIH trial results weren’t peer reviewed yet. In May, I presented research at the Pediatric Academic Societies meeting confirming retrospective studies that needle fear is acquired between ages 4-6: 9% of children who received at most 2 shots at once between the ages of 4-6 were in the upper quartile of needle fear at their 10-11 year visits. 43% of kids who got 4 shots were in the upper quartile of fear. I followed them another 3 years, and kids in the upper quartile of fear were 2.5x less likely to start their HPV series. Whether their parents were nervous about their vaccinations wasn’t correlated – it was the kids’ fear.

    While Buzzy HAS been a part of decreasing needle fear, and the combination of Descending Noxious Inhibitory Control and Gate Control are very helpful for older kids and adults, it’s not the answer for decreasing pain at the 4-6 year visit. Distraction and caring about pain are likely huge helps in decreasing traumatiziation from pain (and I use that word advisedly), but we really lack prospective data on this. Ralph Berberich has published great work showing that cold and vibration decrease immunization pain in the 4-6 year range – I hope they evaluate their teens to see if their rate of needle fear is lower than kids immunized without concern for pain. They used the vibration on the contralateral side, so it was complete distraction in their studies, used in conjunction with a distracting game that is a GREAt idea.

    I’m happy you’re bringing such thoughtful attention to this problem. Public health is a lifelong process.

    Take care, Amy

    1. WilliamLawrenceUtridge says:

      Dr. Baxter,

      Based on Dr. Jones’ commentary, what controls do you think are necessary for your subsequent study of this device you sell?

  7. Clay Jones says:

    Dr. Baxter,

    Thank you for taking the time to respond to my questions and criticisms. Before I go any further I do want to state again that we share significant common ground in this area of pediatric practice. Poorly treated pain is a big problem and I am always encouraged when people are dedicated to making the world a more comfortable place for kids.

    “Buzzy simply combines two modalities for relieving pain: cooling and massage. Both are FDA Class I minimal risk modalities of making minor aches and pains better. ”

    -True, but the Buzzy isn’t used in quite the same way. Minor aches and pains can be treated to a certain degree with direct application of cold and massage to the injured area while for most applications of the Buzzy it is recommended to target proximal to the area where sharp pain is going to occur. I don’t think it is fair to equate the massage of a sore muscle to vibrating the area above where a needle will cause very brief sharp pain.

    The Whelan Study (http://cpj.sagepub.com/content/early/2014/06/11/0009922814538494.abstract?rss=1) was published in June of this year and I wasn’t aware of it. According to the abstract it involved asking a small group of kids aged 4-18 and a few phlebotomists whether or not they thought that the Buzzy was better than nothing. Again, not the kind of data I’d put too much stock in.

    The Canbulat paper (http://www.mdlinx.com/pain-management/news-article.cfm/5328369/procedural-pain-peripheral-intravenous-cannulation) also from June of this year, again compared Buzzy to no intervention and did not account for placebo effects.

    In regards to needle fear, I’ll examine your data once it’s published. But I question whether or not the primary issue is the pain from the shots rather than general resiliency and coping skills that are often learned from parents. I argue that this is one of many potential confounders. I don’t think it is fair to claim that kids who express anxiety regarding receiving immunization are going to have decreased immunization rates or avoid routine care.

    1. brewandferment says:

      My middle kid would work up quite a fuss and panic for vaccines or any other potential needle stick well beyond the age that I would have expected–much of it entirely self-generated to the point of complete exasperation on both my part and the poor nursing staff who had to administer the sticks. We always approached them in the same calm, matter-of-fact fashion as for the other 2 kids so I don’t know why one kid became so freakishly worked up even into tweens (only seemed to finally settle down from the drama at age 12 when an IV for imaging was required after an auto accident) when the others just gritted their teeth and sniffled a little bit at most. I think as a distractor this would have worked pretty well for said kid, and for small practices in an office setting I can see it having use for kids like mine who were known to be drama makers/panickers for minor procedures like vaccines or finger sticks (cholesterol check as one example.) I wouldn’t have suggested it until a kid became a known difficult stick so that it didn’t become the trigger for panic, but once they get to the point of needing a full body pin (only slight exaggeration there) to get a vaccine in them, it sure seems like a better option even if it’s only the elaborate placebo/distraction doing the job.

      I saw Dr. Baxter’s pitch to Shark Tank recently. Was fairly impressed by the product, but less so by her business tactics and unwillingness to heed guidance from the Sharks, who were generally favorable toward the product.

    2. brewandferment says:

      ps–I used the term “business tactics” and realized after hitting send that it may have come across perjoratively. It wasn’t an ethical issue, it was a strategy that didn’t seem as effective as that suggested by the Sharks.

      1. Clay Jones says:

        Here is the video of her episode. I had never seen the program Shark Tank before. Like most reality shows, it seemed like a lot of the discussion was left out which could have made her decision make more sense. Or it could have made her look worse. https://m.youtube.com/watch?v=x43u0XiwSzY

        1. brewandferment says:

          yeah, not the biggest fan of reality shows for that very reason–but there have been some cool ideas that I’ve seen the Sharks support, and some that I think they wanted to support but the business basics weren’t in order. And a few didn’t have well-developed business plans yet the idea was good enough that when an entrepeneur needed guidance and help that a Shark (s) was willing to give it, they got funded anyhow. Those cases seemed to have entrepeneurs who were especially open to guidance. But it still might have been edited for entertainment anyhow.

  8. Al Stroberg says:

    Neither of my kids (now 26 & 27) complained of pain at childhood vaccination time, despite the problem of having physicians as parents. They bargained, whined, but then went vaso-vagal & passed out. #2 even did that after his pre-college vaccinations- I found him slumped to the ground outside the peds office. Sigh.
    Do you think early Buzzy use would have altered this reaction?

    1. Clay Jones says:

      What I can say is that there isn’t any evidence to support the claim. My opinion is that I don’t think this specific device would be more likely than other forms of distraction to prevent needle fear.

  9. Missmolly says:

    We use these fairly routinely in the cancer centre for IM and subcut injections, as a part of our arsenal of distractions and topical pain relievers. The bee IS cute, and kids really like turning him on and off and having a bit more interaction with the process.
    The major benefit I see is convenience. When we were first setting up the procedural pain management service (Comfort First in our institution) we used to use ice from the tearoom stuffed in a path bag- not so adorable! And having a vibrator, sorry, ‘personal massager’ in a kid’s cancer ward would def have been seen as a bit pervy :) All-in-one in a compact, kid-friendly package is really lovely- and you can use the bee metaphor to engage about the ‘stings’ that still may occur. Our kids also obviously have recurrent procedures, and even the ‘phobic’ ones don’t seem to associate the bee with badness- rather, they will ask for the bee when a procedure is proposed.
    I am totally sold on the power of vibration- whether it’s distraction or pain gate, it really seems to make a difference. Inspired by the bee, I’ve used my phone on vibrate to put in sub cut needles when I’ve been caught without topical anaesthetic or with limited time on home visits, and it has been awesome.
    I hope decent studies will be done to explore the true efficacy of this kind of product. I wouldn’t rush out to buy one for home, but in the cancer centre its convenience and discussion-point-ability has been very useful.

  10. Scote says:

    “nspired by the bee, I’ve used my phone on vibrate to put in sub cut needles when I’ve been caught without topical anaesthetic or with limited time on home visits, and it has been awesome.”

    Aren’t cell phones one of those common devices that are covered in coliform bacteria because we don’t/can’t clean them properly?

    That being said, I do appreciate when my dentist does the pinch and shake when doing injections. I don’t know or care if it has an actual analgesic effect, I only care that it makes me feel better (for whatever reason).

    1. Missmolly says:

      Happily the phone is placed proximal to the site of insertion rather than actually on it (not sure how that would work!) so I’m pretty sure we were ok, although I take your point!
      … Actually in all three of the cases I did that, the patient didn’t survive long, which I always thought was my choice of profession… Hmmm, maybe my bad.

  11. While I applaud the efforts of Dr. Baxter, I suspect the scientific rationale and potential mechnisms behind “Buzzy” are a bit lackluster (please note my critique is of the rationale used; not the actual device).

    Whilst many of us learned “The Gate Control Theory”, as developed by Melzack and Wall in 1965, it is not the most currently accepted theoretical model for pain, within the circles of those who study pain.

    In 1998, Melzack developed the concept of the Neuromatrix. We used to believe, as the author states, “With gate control, a typically non-painful stimulus “closes the gates to painful input”, which reduces CNS awareness and dulls the sensation of pain.”, but we now understand that there is no such thing as a “painful input”. Nociception occurs and likely occurs often; but it is actually a central mechanism, or output, that leads to the perception of pain. In simplest terms, we now suspect the conscious brain, made up of individualized centers which we term The Neuromatrix, determine the degree of “threat”, whether real or potential, and decides how to repond. Here is a very basic overview I wrote for the American Physical Therapy Association: http://www.moveforwardpt.com/SymptomsConditionsDetail.aspx?cid=e6dabed7-c6d5-4362-8260-9ce807427619#.U7f0z00nLIU

    So if the buzzy doesn’t inhibit painful inputs (which cannot be done because pain is not yet existent), how may it work? I suspect, like many modalities (TENs, Ice, etc) used in my own profession (Physical Therapy), it is a combination of novel input and placebo. Again, pain is likely an output based upon potential threat. By modifying the input, we may make the brain less defensive (this is on an individual basis because the neuromatrix is individual based upon past injuries, prior experiences, etc). I guess you could call this “descending inhibition” but I suspect the novelty of the device in and of itself may elicit a placebo.

    Overall, I suspect the device is “safe” and may be more safe than other interventions used in the management of pain, but I think the explanatory models used to explain its potential effectiveness need to be updated (I thought this as I watched this device pitched on Shark Tank—-great show).

  12. G Vazquez MD says:

    As a practicing pediatrician for many years, I can tell exactly which kids are going to be the most upset and experience the most pain from vaccines just by looking at their parents. A very scared and nervous parent makes for a scared and nervous child.I’ve used small amounts of BLT ( a topical anesthetic) on the patients whose parents were the most upset by vaccines and even though BLT is effective I didn’t see a bit of change in the kids reaction to the procedure.
    Who knows, maybe the Buzzy Bee works as a placebo by reassuring the families and therefore the kids that the procedure ( vaccine or finger stick blood draw) will be less painful, sort of a reverse of how acupuncture works.

    1. brewandferment says:

      maybe in some cases but I can tell you I was never fearful or anxious with my kids’ shots–although sometimes I had to get on my husband’s case about anticipating stuff when he came with us. Nevertheless, I have always been calm until the middle kid’s dramatics made me exasperated beyond belief! An urge to strangle was more what I was feeling….

  13. Birdy says:

    When I was about five, I was being admitted to the hospital and a nurse came to draw blood. She took out a hand-crocheted finger puppet and gave it to me. She told me to turn my head and have the puppet count to ten. By then, she was done. She let me keep the little finger puppet and I keep it in my first aid kit so that I can give it to my kids when I clean their wounds. It distracts them enough that an unpleasant moment is easily ignored.

    I’ve found distraction alone useful with my kids. Think I’ll take a pass on the $40 gadget that I would always forget to chill.

  14. CS says:

    To be honest, I found this article to be overkill. With all the SCAM topics to choose from this one would not top my list. It looks like a perfectly harmless, fun toy to try to use that may work in some kids and not in all but worth a try. My guess is that if it’s effective it’s due to a combination of novelty and placebo effect, but the cost and risk are low enough to use in an office setting. I probably would hesitate before spending the money or recommending it for home use.

    The article you linked to on managing acute pain in kids has more to do with the hospital setting and not for minor procedures in an office setting where we do not have access to child-life. So you knocked down a potential solution without offering alternatives.

    I am a pediatric nurse practitioner in a peds pulmonary practice where we do a fair amount of allergy tests. I would love to learn how to do a better job of calming them and talking them through the procedure. We do use distractors but some kids are so freaked at the thought of the needle they won’t even touch the distractors offered.

    1. Clay Jones says:

      Articles like this, and many that are written on SBM, are about more than just the specific bogus therapy or, in this case, somewhat questionable device. It’s also about the process of thinking through these things that could potentially be extrapolated to other areas of medicine and other devices, many of which have more potential for harm and wasting resources.

    2. Andrey Pavlov says:

      Indeed it is. The very idea of SBM is that all proposed medical devices, therapies, and interventions can and should be approached in a methodical and rigorous manner. You are doing precisely what we argue is poor form and poor practice – giving something a pass on weaker evidence just because it is harmless and may or may not have some instances of utility.

      Yeah, we agree that Buzzy is harmless (or at least certainly nearly entirely harmless, I’m sure anyone could contrive some remote harm). But it is not just about the harm. It is about the utility and how to determine that. By reacting the way you have and just saying:

      It looks like a perfectly harmless, fun toy to try to use that may work in some kids and not in all but worth a try.

      you’ve entirely short-circuited the entire EBM/SBM process. There are plenty of things that you could say the same (or very similar at least) things about. Reiki, homeopathy, acupuncture, reflexology, and so on. To a varying degree your statement could perfectly reasonably be applied to any of those as well.

      Granted would this specific item have been high on the radar here to do such a detailed and “overkill” analysis? Probably not. Except for the fact that Dr. Baxter has been on TV and TED talks but really because, as Dr. Jones said, his hospital asked him to review it and render a decision about his institution buying the thing.

      Do you think it would have been satisfactory for him to have submitted an opinion that said nothing more substantive than:

      It looks like a perfectly harmless, fun toy to try to use that may work in some kids and not in all but worth a try.

      ?

      1. CS says:

        Yes, I do think there should be a hierarchy of topics, with those having the most potential for harm or highest patient cost (in terms of time, money etc.) should get the most detailed treatment, while giving a pass on basically harmless toys.

        Yes, I agree it would have been better if this toy had been marketed differently. I don’t see it as much different than any other distractor out there, and Dr. Jones’ point seemed to be that distraction works with peds so why do we need this toy.

        I guess what got me miffed enough to write was that I was drawn to read the article because I’m on board with the idea that we too easily dismiss pediatric procedural pain, and we’re very focused on just getting the job done and don’t pay enough attention to the child’s feelings. I agree with this and I plead guilty to this as well. But Dr. Jones’ advice seems to be limited to “call in the child life team — they know what they’re doing,” without even explaining what techniques the child life team uses or what an office-based provider can do if they don’t have access to a child-life team.

  15. Scote says:

    “So you knocked down a potential solution without offering alternatives. ”

    Not having an alternative treatment is not a valid reason to withhold scientific skepticism of an existing treatment. If something does not, in fact work, then the lack of an alternative is irrelevant.

    1. CS says:

      It’s a toy.
      It’s not a medical treatment.
      It’s no different than a finger puppet.
      Do finger puppets “work”?
      What about slinkies?
      Maybe stickers are best.
      Let’s do a double-blind controlled study!!

      1. Missmolly says:

        From my reading, it’s not intended to be a toy/distractor. It’s marketed as having therapeutic efficacy as an analgesic device through vibration/ice. Given the marketing and the fact that there have been trials comparing its efficacy with other standards of care, it doesn’t seem unreasonable to interrogate those trials.
        Though I agree that a one-off payment of $40 is a pretty benign outlay (for a potentially no-better-than-placebo intervention) compared with, say, Burzynski’s antineoplastons :)

  16. I feel compelled to add another for your consideration. I recently, serendipitously, was introduced to an all natural patch that has reduced my sciatica pain, on a 10 scale, from an 8-9 to a 4. I’m an obese 71 year old man and these patches have significantly improved my quality of life.

    Best of all, they will send free samples anywhere in the world . They do not require a credit card, shipping fees nor a purchase.

    You can check it out here: adhocnews.org/chronic_pain_relief

    1. WilliamLawrenceUtridge says:

      My god, that’s remarkable! FDA-approved device and they don’t need a credit card? Why that couldn’t be a scam at all and you almost certainly aren’t a grotesque shill!

      What’s in the patches? The advertisement with a conveniently-attached order form you link to doesn’t say. Are there contraindications? Could it cause allergic reactions? Is it synergistic with other pain medications? Because being able to order random medical supplies off of the internet is never a bad idea.

      1. Nell on Wheels says:

        It’s a MLM scheme: http://fgxpressstrips.org/faq/

        As to what’s in it: http://fgxpressstrips.org/

        FGXPress Power Strips Review
        FG Xpress Power Strips is an up and coming natural pain relief patch that can be directly applied to virtually any constant, consistent, painful area. The PowerStrips are completley effortless to apply and quite literally FDA-approved.

        FGXpress Power Strips For Joint & Back Pain?
        Back Pain Power Strips
        When exploring the potential benefits of FGXpress Strips, remember virtually no miracle pain relief solutions exist. So before dissecting and distinguishing what can and cannot, let’s clear the focus that Powerstrips are miracle-workers…

        …Infused with the “greatest ingredients” and artfully-formulated with most innovative-technology, these Pain Relief Power Strips by FG Xpress are known to improve the way a body functions as a whole. Leading the way is one of the biggest cataylysts in PowerStrips, Korean Red Ginseng. This herb contains large quantities of saponin, which is a substance with great healing capacities and absolutely no side effects.

        http://fgxpressstrips.org/about/
        FGXpress Powerstrips also contains silver. Silver has been proven for decades to possess good antimicrobial properties. With continued use, the silver is effectively distributed throughout the body, forming a protective shield from harmful bacteria, fungi and protozoan. There are studies have shown that newer strains of microbes are resistant to some anti-biotic, but they haven’t develop immunity to silver.

        FGXpress Powerstrips is a just more than a pain relief patch; it is a product that promotes overall health. The benefits are many, and it is safe for body use. If you are looking for a patch that offers just more than pain relief, then you might want to try FGXpress Powerstrips.

        Please keep in mind and common sense that none of these statements have been viewed or verified by the FDA. This FGXpress Power Strips website is dedicated to giving you expert reviews about the intelligent information and common content being shared about Forever Green’s FGXpress.

        1. WilliamLawrenceUtridge says:

          I love how they are “quite literally FDA-approved”.

      2. MadisonMD says:

        We have seen that spam before. Good to see that they no longer claim FDA approval. It’s registered with the fda as a cold pack. Maybe Windriven’ s note to the fda had an effect.

        1. Windriven says:

          @Madison

          Actually, it appears that they do still claim it to be FDA approved. So it would appear my note went nowhere.

  17. E-rook says:

    I have two childhood memories of needle sticks from immunizations. One, I was frightened and fussy and fearful from the anticipation of the pain. But when it actually happened, I was surprised at how fast it was over with. The pain from all sorts of scrapes, scraps, and falls lasted longer and was more intense. I used to get scraped knees/hands/elbows/hands A LOT. A second one, I remember being totally distracted by someone who was talking to me, asking questions, and cleaning/handling my left arm, holding up my sleeve etc., and the needle stick was stealth-ninja style on the other arm from where I was paying attention. Again, I remember being surprised, “it’s done?” And then a little miffed at having been tricked.

  18. Anna says:

    As someone who has suffered from both needle-phobia and bee-phobia my entire life, I’m not sure that a gigantic bee on my upper arm would have put me at ease.

    1. Chris says:

      Perhaps a furry purring chilly kitty?

      1. simba says:

        Undead kittens you say?

  19. Chris Hickie says:

    I’ve always wondered if TENS could help with shot pain. Not wondered enough to want to do a study. I’m also not sure how many infants and children would like the sensation of TENS. In the past I’ve also assumed TENS was in the realm of the physical therapists and/or under the direction/prescription of a physician. Now I find, however, that (at least according to the manufacturer), you can buy Icy Hot as part of a portable/disposable TENS unit, without a prescription. Go figure. Their FAQ says only to use it on the back. You can bet money it won’t be long before people will be taking advice off the internet about other “uses” for this. Disclaimer: I have no COI. I have no monetary interest in Icy Hot and have never used any topical pain cream like it.

  20. Bruce A. Hamilton says:

    Re: “it only costs about $40 per device, which is pretty cheap.” I think our standards have been warped by various absurdly-overpriced devices and procedures. I consider $40 to be way overpriced for a device that apparently just vibrates and retains coolness. I would guess it has a unit manufacturing cost of closer to one dollar than to forty.

    1. Windriven says:

      The rule of thumb for an innovative new product is 5:1 price to cost. People not familiar with manufacturing often underestimate the actual cost to produce something, especially before volumes justify advanced manufacturing techniques to lower costs. Figure the thing probably costs closer to $8.00 including packaging.

      1. brewandferment says:

        follow Clay’s link to the Shark Tank episode. Been awhile since I watched it but I think $8 is lower than she cited.

        1. Windriven says:

          Sorry brew, I’ll take your word for it. I’m not willing to invest 38 minutes.

  21. Amy Baxter says:

    A few additional comments now that I’ve calmed down more.

    1) As I’m sure you read in the full papers, Dr. Jones, in the discussion we explore why we were unable to blind the video reviewers (even though we didn’t show the affected extremity) because of the sound. We asked the reviewers if they could guess which intervention was used, and of course all of them could. Most pain scales for young children (CHEOPS, FLACC, OSBD-R) that use video scoring have a verbal component, so you can’t just turn the sound off. We did use a sham Buzzy in our self-rated and parent-rated teenage trials (which I presented at a PAS, so it’s not on the website). Sham was statistically equivalent to no intervention. (By the way, since I’m sure you wouldn’t review the literature without having evaluated the full papers and not just abstracts, I would love a copy of the Canbulat N article, as my institution doesn’t subscribe to Pain Nursing.)

    For those inspired to do a Buzzy trial with sham, I recommend putting a Buzzy on both arms but have the vibration turned on contralaterally so there is sound in the room. To really tell whether it’s distraction or actual physiologic nerve effects, don’t freeze the ice pack on the distraction side -DNIC, which above review doesn’t spend a lot of time on, is a descending phenomenon and likely contributes more to Buzzy’s efficacy than Gate Control. You’ll get some pain relief by putting the cold anywhere if it’s cold enough. By the way, to test yourself whether motion and cold block pain or it’s cognitive distraction, next time you burn your finger, run cool water on the opposite hand to evaluate.

    One of the studies done by Inal et al looked at Buzzy alone (56% pain reduction) and added the Distraction Cards (88% pain reduction). This to me indicates the degree to which Buzzy is a cognitive distractor v. a physiologic affect. If you’re going to do research, email me directly at abaxter@mmjlabs.com if you can’t get access to any of the PUBMED papers or published abstracts (apart from the Canabulet one).

    2. Criticisms of the sample size: When an effect is large enough, a small sample size is adequate to demonstrate efficacy. When you have a very large cohort, you run the risk of finding a statistically significant difference when there is no clinical difference. The criticism that Buzzy studies are “small” is actually a clinical testament to its efficacy: ALL the published peer reviewed studies showed a statistically significant decrease in pain. You erroneously report above that the study with the pilot device did not show statistically significant decrease in pain. Actually, the Buzzy prototype did significantly decrease pain (see below). That the cold spray arm did not show a significant reduction is an interesting finding given the widespread use of cold spray and multiple studies showing efficacy for children and adults 12 and older. This shows again the effect of sample size: small cohort, you need a larger effect to show a difference. Lack of finding a difference in the pain relief of cold spray in our study doesn’t mean cold spray doesn’t work for adults, it just means the effect was too small to be seen in this small crossover trial.

    Baxter AL, Leong T, Mathew B. External Thermomechanical stimulation versus vapocoolant for adult venipuncture pain: pilot data on a novel device. Clin J Pain 2009 Oct;25(8):705-10.
    This was a crossover pilot study of 16 adult patients using Buzzy or nothing and 14 patients using vapocoolant spray or nothing. Those with greater needle anxiety were more likely to experience pain relief with Buzzy. The Buzzy device prototype significantly reduced pain (p=.035) while vapocoolant spray did not. Interestingly, there was a significant increase in likelihood of pain relief for each centimeter of increased anxiety. Whether more anxious patients benefit more from Buzzy or whether increased anxiety comes FROM greater skin sensitivity is an interesting area of exploration.

    Other works with statistical significance included:

    Inal S, Kelleci M. Relief of pain during blood specimen collection in pediatric patients. MCN Am J Matern Child Nursing. 2012 Sep;37(5)339-45.
    In this randomized controlled trial, 120 children aged 6 to 12 years underwent phlebotomy, either with no intervention for pain management or using the Buzzy device with cold and vibration throughout the procedure. The experimental group showed significantly lower pain (p<.001) and anxiety levels (p<.001) throughout the blood specimen collection. Authors concluded that Buzzy decreased perceived pain and reduced anxiety throughout blood collection, without decreasing the effectiveness of the procedure.

    Baxter AL, Cohen LL et al. An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatric Emerg Care 2011 Dec;27(12):1151-6
    In this first study of pediatric patients undergoing phlebotomy or IV cannulation in a pediatric emergency department, patients were block randomized by use of LMX or no intervention in triage. When the 4 to 18 year olds were cannulated, they were randomized to Buzzy or cold spray. In the 81 children, median age 10 years, Buzzy was associated with both lower pain scores than cold spray by self report on the Faces Pain Scale Revised (-2 on 10 point scale) p=0.029, by observer report p=0.036, and by parent report p=.005. Venipuncture success was more likely with Buzzy, OR 3.05; 95%CI 1.03-9.02).

    Itching: Troger, A. Robinson H et al. Helping Children Cope with Discomfort Associated with Skin Prick Testing in a Pediatric Setting: A Quality Improvement Report. J Allergy Clin Immunol 133 (2) 2014:A
    In this prospective study presented at the 2014 AAAAI conference in Denver, the authors evaluated 54 children’s coping with the administration and waiting portion of itching skin tests. Interventions included Buzzy (without ice wings), an electronic tablet distraction, parental comforting, and no intervention by parents. On a 5 point likert scale of coping from 1 (poor) to 5 (very well), Buzzy was the best waiting intervention, with 90% of patients at a 4 or 5, compared to 65-75% for the other interventions. Of note, ice provides 60% of Buzzy’s pain relief, so further testing including ice may produce better results.

    3. Buzzy is currently used in over 5000 clinics and hospitals. Child Life includes Buzzy in their arsenal in most Children's Hospitals. The reason I invented the DistrACTION cards in addition to Buzzy is that pain relief needs to be multimodal – the experience of a pain for a child includes fear, how much attention they're paying to the procedure (and I did worry that Buzzy would INCREASE the attention to the procedure and make it worse, but fortunately the research doesn't suggest that) and pain itself. Whether Buzzy is a convenient source of physiologic pain relief or cognitive distraction or pure placebo probably doesn't matter except to me – it is reusable, and costs 1/5 of even what cold spray costs. Hospitals pay $6+ per stick when they try to decrease the cost of IV pain with creams or lidocaine formulations, and patients are charged multiples of that.

    4. For a great scholarly work regarding the acquisition of needle fear, I recommend the work of Dr. Christine Chambers http://pediatric-pain.ca/faculty/chambers/publications/ as well as Theories of Pain Acquisition in the Pediatric Pain Newsletter http://childpain.org/ppl/issues/v10n2_2008/v10n2.shtml

    5. I moved Buzzy production to the USA. It was the right thing to do, but the speculations of my unit price to make it and pack it are way underestimated.

    Whew! I feel better. Thanks for being so transparent and open to allow such a long discussion. Annoyed as I was by the snarkiness initially, I do think that the more forums that encourage transparency, skepticism, and respectful discussion about issues that affect health benefit us all. Science is complicated, and statistics "can be used as a drunkard uses a lamppost, more for support than illumination". The opportunity for commentary allows for refinement of ideas.

    PS: to be a TEDMED Scholar, you have to fill out a few essays about why your work is pushing boundaries or innovating for public health and include your publications, book chapters, lectures, etc.. You do then get a half price rate if accepted. I agree that the designation isn't something to put on one's CV, but the experience made me a better doctor and researcher.

    1. What do you suspect would happen if you created multiple, simple RCTs with the following group scenarios:

      Study 1. Control: Patients receive a “Buzzy”. Experimental: Patients receive a Buzzy but the tester calls it a “Stinger”. I suspect there is clever novelty in the “term” that may in and of itself, have an effect on the neuromatrices response.

      Study 2. Control: Patients receive a “Buzzy”. Experimental: Patients receive a “less friendly looking” version of the device. Visual input can elicit a defensive response from portions of the brain which comprise the neuromatrix.

      Study 3. Control: Patients receive a “Buzzy” from a friendly tester with reassuring mannerisms. Experimental: Patients receive the “Buzzy” from a less supportive or friendly tester. There is evidence to suggest “therapeutic alliances”, in and of themselves, can elicit changes in pain. When studying the “Buzzy”, you need to control for “clinical equipoise” and attempt to test if there is an elicited response from the individual administering the device (I suspect many IDE trials fall short in even attempting to control for this)

      Having a fairly decent understanding in the neurophysiology and neurobiology of “pain”, I am not truly convinced the effects can be contributed to “cold” and “vibration”. Both obviously elicit input, but I am attempting to demonstrate with the scenarios above that: 1. pain is quite complex 2. can no longer be “gated” as we once thought (its an output; not an input) 3. reduces when individual neural centers suspect less of a “potential” threat

      I think you have a good idea with the “Buzzy”. I think when you attempt to be too certain that the effects are secondary to “vibrating” and “coldness”, you will fall short within the scientific circles

  22. I have 4 of these in the office and they work in “some” patients. I wish I would have some of these to use when I worked in Pediatric Urgent Care/ER. All it does is “distracts” from the procedure. You can distract with an ice cube or a different vibrator, not big deal.

    But remember all biological subjects are inherently different so they should be offered a variety of alternatives for their comfort. Unnecessary trauma is just unkind.

    Here is a cheaper but similar concept:
    http://www.bluemoonhealth.com/massage_pages/point_mini_3000.htm

    These are nifty to have around:
    http://www.bionixmed.com/MED_Pages/ShotBlocker.html

    This thing is a life saver:
    http://www.dermojet.com/

    This is awesome to have also:
    http://www.porterinstrument.com/product/dental/Nitronox%20Field%20Unit

  23. Michael P. Stein says:

    I can think of one other plausible non-placebo mechanism for vibration to help, touching on Calli Arcale’s comment above. When I was a child, I had an idea that shots might hurt less if I tried to relax my arm as much as possible, on the theory that a tense muscle would offer more resistance to the needle, and therefore more pain. It seemed to work. Of course that could have been a placebo/expectation effect, though interestingly I did have a nurse giving me a flu shot last year tell me to relax the arm as much as possible. If my experience was not just placebo effect, a vibrating device might help in loosening up the muscle and reducing resistance.

    The experiment I thought of to minimize placebo/expectation effect is to tell the recipient that the purpose of the vibration is to help spread the vaccine faster, not to make it hurt less. Try no Buzzy, a Buzzy with vibration only, a Buzzy with cold only, and a Buzzy with both cold and the vibration.

  24. Amy Baxter says:

    I like that idea, Michael! Actually, the physiology of relaxing a muscle probably deceased your overall tenseness, as well as decreasing the density of the fibers.

    Interesting new paper on the mechanism of high frequency vibation and pain. Perception. 2014;43(1):70-84.
    How does vibration reduce pain?
    Hollins M, McDermott K, Harper D.
    Abstract
    Cutaneous vibration is able to reduce both clinical and experimental pain, an effect called vibratory analgesia. The traditional explanation for this phenomenon is that it is mediated by lateral inhibition at the segmental (spinal cord) level, in pain-coding cells with center-surround receptive fields. We evaluated this hypothesis by testing for two signs of lateral inhibition-namely (1) an effect of the distance between the noxious and vibratory stimuli and (2) an inhibition-induced shift in the perceived location of the noxious stimulus. The experiment involved continuous ratings of the pain from pressure applied to the back of a finger, alone and in the presence of vibration delivered to sites on the palm of the hand both near to and far from the site of painful stimulation. Neither prediction of the segmental hypothesis was supported. There was also little evidence to support the view (widely held by subjects) that distraction is the primary mechanism of vibratory analgesia. The results are more consistent with a recently proposed theory of interactions between two cortical areas that are primarily involved in coding pain and touch, respectively.

  25. Dashbrook says:

    As a childhood cancer survivor, I have been poked a gazillion times. I can see how this might be a cute distraction for a blood draw or other minor needle pokes on small children—but so are a million other things. I dare someone to say this works well for pain relief in a bone marrow needle. We were given “prizes” ( very nice toys) after enduring those needles. Those prizes made the pain more mentally tolerable knowing an awesome toy was on the way. They still hurt a lot!
    Buzzy looks like a cute fun toy, but not a medical device anymore than ice is for a sprained ankle.

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