VIBRAJECT®Dental syringe gate-theory vibrator
Vapocoolants by Gebauer Co.
Line of skin refrigerants
LIDOSITE®Iontophoretic dermal anesthesia system
| VIBRAJECT® Dental syringe gate-theory vibrator |
Vapocoolants by Gebauer Co. Line of skin refrigerants |
LIDOSITE® Iontophoretic dermal anesthesia system |
Description: The VibraJect device is a very interesting implementation of the Gate Theory - it reduces pain from dreaded dental injections by vibration. It is a miniature vibrator that snaps onto a dental syringe. The intense vibration overwhelms the patient's nerves and therefore 'distracts' the brain from perceiving the lower-intensity signals coming from pain nerves. The patient feels vibration rather than pain.  The VibraJect system is not a substitute for
dental local anesthesia
injections. Rather, it helps the patient tolerate anesthetic
injections. Many needle phobes will tell you that they fear the
pain
of dental injections more than dental procedure pain. The
VibraJect
system was developed to solve this dilemma. The VibraJect system consists of the vibrator, a set of rechargeable batteries, a battery charger and printed instructions. Review: the first thing you notice when you turn on the VibraJect is just how intense a vibration that this tiny little device can generate. WOW! Its immediately easy to see how it works. The manufacturer claims (backed up by clinical studies) that the device offers more pain blocking than dermal anesthetic paste which is the current standard-of-care. When we first tried it we ran into our first problem - the dentist said that his technique is so good that such a device is simply not necessary. Overcoming such professional arrogance is a big challenge facing the manufacturer of this product. "I insist" said the Keith Lamb, the NPIC director. Mr. Lamb is admittedly hyperalgesic (unusual pain sensitive) so it was difficult to overcome the perception of the needle pain. Still, the manufacturer's claim that it is as good anesthesia paste seems to hold true. The super-intense vibration of the needle in one's gum is a bit hard to get used to. The last thing patients want to feel is someone moving the needle around...that is, except pain. The VibraJect system does what it says it does. Given how fearful we all are of dental injection pain, give us topical paste AND VibraJect AND very very slow technique. Bring it on, Dr. Dentist, we want it all. Cost and Availability: the VibraJect system is marketed toward dentists, not patients. Therefore it suffers from the most common problem that needle phobes face when it comes to anesthesia - availability. You can't simply buy one from a pharmacy or over the internet. If you want this treatment, you will need to ask your dentist. If enough patients ask (demand?) it, perhaps it will become a standard treatment. To the VibraJect manufacturer - we'd like to see a way that a patient can buy this (from your web site?) and carry it with him to the dentist office, preferably without a prescription but even a prescription requirement is acceptable to us. The patient can then tell the dentist that they must use this device. Just knowing that the patient can control this feared aspect of the dental visit can bring them a great sense of relief even fore the needles come out. The system costs only a couple of hundred dollars, spare change when you compare it to other tools in a modern dental office. And since it can be used on patient after patient and it employs rechargeable batteries, its cost per application is nil. It doesn't appreciably slow down dental procedures and its easy to use requiring virtually no training. Summary: The VibraJect system is a quick and effective non-drug topical dental anesthesia device that requires virtually no training. The NPIC would like to see this become a standard-of-care in dental offices. |
Description: The Gebauer Company is a family-owned medical products company that has been producing anesthesia products over 100 years! Every physician knows of Gebauer's masthead product, Ethyl Chloride®. It has been used for nearly a century as a skin refrigerant to provide near-instant skin anesthesia. This freezing spray is one of several products the company manufacturers with the more modern technical name of "vapo-coolant". They are indicated for IV starts, and blood draws. A sterile vapo-coolant is now available from the company which expands its use to minor surgical procedures including wound suturing. We all know that ice or extreme cold on the skin makes it numb. The process is simple - cooling things slows down chemical reactions, and our bodies are a big chemical reactor..including our nervous system. Nerve conduction, the speed of a nervous impulse, is slowed down by cold. That's why frostbite doesn't hurt, that is, until the patient is thawed out. The Gebauer Company recently invited the NPIC director, Keith Lamb, to visit their state-of-the-art ISO 9001 and ISO 13485 manufacturing facility in Cleveland, Ohio. While visiting the company one finds the firm's mission statement prominently displayed in a wall in the main hallway - something that the employees can't help but see many times a day, "With HONESTY and INTEGRITY, we shall provide effective products to improve our customer's quality of life while responsibly promoting profitability, stability, and growth for our business, employees, shareholders and our community". Standing in front of Gebauer's mission statement is NPIC's founder D. Keith Lamb (on the left), and Mark Geiger, Gebauer's Vice President Sales & Marketing.  Background: With the huge cost of research, development, regulatory compliance/approval and marketing of modern pharmaceutical products, its easy to rest on your past success, especially if you own the market in a particular area. Gebauer has owned such a market for a century - dermal anesthesia using vapo-coolants, a class of chloro-carbons that have such a low vapor pressure that they vapidly evaporate upon exposure to atmospheric pressure. And as we all know, rapid evaporation reduces temperature. On the skin this rapid evaporation causes a near instant freezing effort on exposed skin. Gebauer is known for Ethyl Choride®, a very rapidly evaporating solvent used for dermal anesthesia. The company even invented its handy container - a glass bottle sealed within a vinyl-like covering to prevent shattering if dropped. The bottle is equipped with a spring-loaded lever. The fluid is dispensed by holding its container upside down over the planned procedure location on the patient, such as a planned IV insertion site), while the lever is depressed. The fluid drips out as long as the lever is depressed. It usually evaporates so fast that the fluid doesn't even hit the floor if it spills over the patient's skin. Products: But Gebauer hasn't sat on its successful Ethyl Chloride® product. It boasts an impressive line of refrigerant products including the new Pain Ease®, a new chloro-fluro-carbon mixture that is slightly less cold than Ethyl Chloride®. Pain Ease® comes in a handy spray can with a choice of spray patterns. Unlike Ethyl Chloride®, Pain Ease® is non-flammable, making it useful in the operating room. Even more impressive, the folks at Gebauer have come up with a multi-dose spray product which is sterile. This is a huge advance because it means this handy little can can be used for wound treatment - irrigation and even suturing. A must-have for a medic kit!   Other
products in their anesthesia line include Gebauer’s Instant Ice®,
an over-the-counter product used by athletic trainers and coaches;
Spray and Stretch® for the management of myofascial pain;
artificial saliva, Review: We have tried and used Ethyl Chloride® for many years. It was the very first topical anesthetic we tried, even before EMLA cream. Our success however has been mixed. Initially Ethyl Chloride® didn't seem to provide much numbness. And its super-cold fluid is a bit unpleasant, especially if you aren't expecting it. After discussing our results with the firm, we were told that the most common cause of lack of positive results is inadequate exposure of the fluid - in other words, not exposing the skin to a long enough spray of the vapocoolant. Since we all know that numbness due to cold is more pronounced the longer the exposure, this conclusion makes a lot of sense. Recently we tried the new product, Pain Ease®, on a patient undergoing IV cancellation for surgery. In the presence of the anesthesiologist, the patient was cannulated using a 21 gauge flexible IV cannula on the dorsum of patient's left hand, without any anesthesia, as a control. The patient was then re-cannulated on their right hand, after application of Pain Ease® following Gebauer's instructions precisely. The patient reported no difference in the pain between the no anesthesia control hard and the Pain Ease®-treated right hand. At first, we explained the lack of effectiveness of vapo-coolants from the simple fact that our previous tests were on patients known to be hyperalgesic. Its certainly possible that hyperalgesic patients need more 'serious' anesthetics to overcome needle/injection pain. But this recent test was on a patient who's response to procedural pain is quite normal. We were disappointed with the results. So far, we haven't seen the expected results from vapo-coolants. But considering the theory, reports from physicians and patients, the company's extensive clinical trials, and the benefits of the product's simplicity, speed of application, and very low application cost, we consider the jury still out. It is NPICs plan to re-test both Ethyl Chloride® and Pain Ease® using a series of application durations. Look here for the results in the coming months. If you have any direct experience you wish to share, please send your email to: klamb@columbus.rr.com. Cost and Availability: Cost and availability are both big pluses with Gebauer's products. While most of the anesthesia products recommended by NPIC are difficult if not impossible to find in your typical physician's office, lab clinic, or even emergency department, Gebauer's Ethyl Chloride® can be found just about everywhere, especially in pediatrician offices, blood draw clinics, and dermatologist's offices. NPIC has seen the ubiquitous bottles of Ethyl Chloride® in many family practice offices. Pharmacies can readily source it. While these products require a prescription, the products are easy to get - it is one line of products that a needle phobe has a good chance of getting approved and even buying their own bottle. The NPIC is a big fan of patient control - just knowing we can carry these products with us in case of need (emergency), is a big anxiety relief just in itself. Summary: Extensive clinical trials and a century of practical experience all point to the effectiveness of vapo-coolants for dermal anesthesia. The NPICs lack of direct positive experience is a bit difficult to explain. We plan to re-test several of these products in both hyperalgesic and normal patients using a series of application durations. It makes sense that the longer we apply a vapo-coolant, the greater the degree of numbness. We therefore plan to increase the application duration (dose) from just under the manufacturer's recommendation of 4 - 10 seconds, to considerably longer (within reason of course). Care will be taken to avoid frostbite, especially with Ethyl Chloride® which is very cold. Pain Ease® should be safer in this regard since it isn't as cold. |
Description: Iontophoretic dermal anesthesia has been around for a long time. This technology involves the application of a small electrical current to a patch applied to the skin over an area planned to receive a needle puncture. The patch is soaked with a topical anesthetic drug, usually Lidocaine, the same drug used by dentists for dental procedures which replaced the obsolete Novocainetm many years ago.  Background: Iontophoresis solves the
age-old problem of just putting Lidocaine directly on the skin, namely,
most drugs like Lidocaine simply do not absorb or soak into the
skin. To be effective enough to numb the skin deep enough for an
IV start, blood draw, or drug injection, the anesthetic needs to be
applied deeply into the skin. But the skin is designed to shed
water and the contaminants dissolved in water. In other words,
the skin is waterproof. A good thing indeed.Iontophoresis works because Lidocaine is soluble in water, that is, it dissolves into its ionic form, a charged molecule. As we all know, like electrical charges repel. So we if soak Lidocaine solution into an electrode patch (like the kind used for electrocardiograms) and apply a current of like charge, the electrode will 'push' the Lidocaine into the skin. The greater the current and the longer the charge is applied, the deeper the Lidocaine will be pushed into the skin. This is ideal for dermal anesthesia...if we only need a shallow numbness because we are doing an injection under the skin, or an IV start, we can applied a medium current for just a few minutes, about 5 or 10 is quite sufficient. If a deep needle procedure is anticipated, simply apply the Iontophoretic treatment for 20 minutes, or increase the current, or both. By varying the current and duration, we can get whatever we want - deeper numbness, or if needed, faster treatment. Iontophoretic dermal anesthesia works. Its level of numbness is impressive. And the control of depth, level of numbness, and duration of treatment are easily controlled. The only negative is that it requires a piece of specialized equipment not found in your typical doctors office. Or emergency room or blood draw clinic for that matter. The drugs it uses are commonly available, but the machine is not. The good news about the equipment is that due to microelectronics, its small - typically the size of a cigarette pack. Cost is about $300-600 but that's a one time cost. The only expendables are the electrode and the drugs, both not very expensive. It requires a prescription, both for the unit and the drugs. The NPIC director has one and swears by it - he carries it where ever he goes. Recently, a new player has emerged - Vyteris, a company formed in the year 2000 as a spinout of the Transdermal Systems unit of Becton Dickinson and Company (BD). We all know BD as the company that makes syringes and needles. One of their first products is Lidosite, a very sexy implementation of the old iontophoretic system. Vyteris has come up with a very neat package that eliminates most of the disadvantages of the previously available systems. Lidosite: As described above, the typical iontophoresis system consists of a cigarette-pack-sized electrical unit, a pair of adhesive electrodes, a set of wires that connect the electrodes to the iontophoresis unit, and the drugs that are soaked into the electrodes. Its a bit of a hassle and two drugs typically need to be mixed just right, and their don't have a long shelf life once mixed. Also, the distance between the electrodes and amount of drug used are all important. And a good battery is essential. Many a iontophoretic application has failed only because its battery wasn't strong enough so one always needed to have two batteries available. Its a hassle and takes a bit of practice. The Lidosite system makes it all easy, and convenient...and it adds safety as well, its near impossible to get it wrong. The Lidosite electrical control unit is incredibly tiny.  Review: The Lidosite system is
simply a joy to use. Its near impossible to get it wrong.
Its tiny, easy to apply, and is fool proof. No drugs need to be
sourced or mixed. There are no electrodes to soak since the
Lidosite system includes drug-soaked electrodes that come in a sealed
pouch. (Picture to the left shows the NPIC founder, Keith Lamb, using the Lidosite system in preparation for a blood draw. The NPIC thanks Vyteris for their non-financial support of this test and review). Positioning electrodes is as simple as pealing off the packing and placing the drug electrode (the one marked with a large red "X") over the planned needle/injection site. Everything else just automatically falls into place. You then just plug the electrode into the little wire that comes out of heart-shaped electrode. The disposable control unit comes with factory-installed long-life battery and a handy little display and set of LED lights that tells you the battery status, that the unit is hooked up correctly and working, and when the treatment is done. No watching the clock, changing batteries, or fiddling with electrode placement. We can't imagine a simpler Iontophoretic system. The cost and availability is the only detriment to the system. And Vyteris is working hard on both. If they can convince physicians that its the new standard-of-care and that doctor's can get reimbursed for the cost by insurance companies, then Lidosite may well be the most significant advance in dermal anesthesia for needle phobics who are hyperalgesic, and even some that aren't. Cost and Availability: The biggest problem with treatments for needle phobes, especially hyperalgesic needle phobes, is that treatments are simply not readily available. Lidosite is no exception. Its marketed to doctors, not patients. NPIC wants to see patient-accessible treatments. Once these treatments become the standard of care everywhere, including rescue squads and emergency rooms, then it won't matter. But until then, the patients want these treatments more than the doctors do. This has to change. Until it does we need a way for the patient to get their own unit. So, Vyteris, we needle phobes need a way to buy your unit. It needs to be affordable so please don't package the drugs/electrodes in packages of 100 or 1000. Fine for a hospital, but not affordable for an individual patient. We need a half-dozen, or dozen treatments. If the control unit is cheap enough when fine, but otherwise we need the batteries to be user-replacable. We understand the advantages of factory-sealed batteries and the liability reduction of a disposable unit, but this makes the unit unaffordable for most patients. At the NPIC we receive many inquiries from patients asking how they can purchase an iontophoretic unit. Just today, for instance, we received this inquiry: "Thank you for your response. My other concern is how can I get a NeedleBuster [iontophoresis] device?". Over the last three years we've received over a thousand inquiries such as this one. Summary: Lidosite is a breakthrough in making a better iontophoresis mousetrap. Its a joy to use and is nearly foolproof. Its only downside is that patients can't buy one, they have to wait until the health care industry steps up to the plate and makes these treatments routinely available. |