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.
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.
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.