I'm Becky Siegel, I'm one of the members of the Pediatric Rehab Medicine Committee through AAPMNR. You guys probably see all of my messages on this forum and Facebook, but we are very pleased to announce Dr. Dita Managu, who I just called Dr. I, who is the Medical Director for Pediatric Rehab Medicine at Franciscans Children's Hospital. And before moving to Boston about two years ago, she worked for 21 years as faculty at UT Southwestern and was instrumental in developing many of their multi-education and clinic programs for med students, residents, and fellows. She does national volunteer work with AAP, AAPMNR, and has mentored multiple trainees at different levels in physical medicine and rehabilitation. She also served as the Program Director for Pediatric Rehab Medicine Fellowship at Children's Health Texas, and has more recently collaborated with Palliative Care at Harvard Medical School for medical student training on disability and transitions of care. Her passions include education and mentoring, global health initiatives, and patient care, and hypertonia, salary, and transitions of care, quality improvement, work, and program development. She's serving on the SAE Committee. She is the Senior Editor of PMR Knowledge Now, the Program Committee for AAP, and the Resident Fellow Board Editor for the Journal of Pediatric Rehab Medicine. And she also volunteers as a faculty internationally training medical students and consulting for disaster relief efforts. And we are so glad that she is here with us to present today on salaria treatment. Thanks, Dr. Rai. Can anybody see it? That's better. So can somebody speak up? I said, that's better. I think it's still maybe a little catchy. If you say a few things that would help. Okay, how about now is this better. Perfect. Yes, and I can hear you now. Wonderful. Let's see if I can share my screen one more time and we can get started. Sorry about this. I am at a ATP DM, this is probably not the best time to do this webinar for me. But here we are Vicki, are you good if I start because I missed your part. Okay, why don't I get started before it's too late and everybody has to go back to their day. So at some point, if I need to stop, you just, you know, raise your hand or put it in the chat. Because I'm not sure I'll be hearing the question, and I want this to be as interactive as possible. So let's start with what am I going to mention today in terms of Silurian. So hopefully this will be a good thought provoking talk about how to start your practices. When you address this big need with our patients cohorts that have issues with Silurian management. So I will be discussing both on and off label use of medication, mostly around the botulinum toxin. And there will be opportunities, hopefully interactive discussions about how to build a team and provide interdisciplinary and actually more than that, which is more of a holistic approach when it comes to management of children with survival issues. And of course, it always starts with basics. We will describe different types of drooling. We will review the research in terms of management, assessment and management. We will look at evidence based medical intervention when it comes to decision making for these patients. And then hopefully we will also describe how evidence based. Again, more than multi, but transdisciplinary intervention for saliva management leads to best outcomes. So we all know what drooling or Silurian means. I think it is important to remember it is normal after 24 months of age. And usually it results by age five, even if some of our kids are delayed. By that age, we should really not be hearing about excessive amounts of patients that are poorly controlled. And the most important, the crypto type of drooling that we deal with in our practices every day is usually the posterior drooling, which is when the saliva spills over the tongue to the oropharynx into the hypopharynx. And that's the one that leads to a lot of complications, this backward motion of the splecia. Saliva is treated by a lot of glands. There are three major ones that we target when we talk about our medical or therapeutic interventions. They're exoping glands. And what we need to know is at a resting state, when our kids are not stimulated by the sight or smell of food, the main gland that treats almost like 60, 70 percent of the whole amount of saliva is the submandibular gland. So when we talk about especially injections, it's really important to target those glands in addition to the other glands, which are easily accessible, but they're only active when our kids are stimulated with some type of sensory stimulator. And then, of course, there are sublingual glands and many, many small glands scattered around or within the oral cavity. And saliva contains a lot of good stuff, electrolytes, mucus, enzymes, antibacterial compounds. And we all know the rate of saliva is not the main issue when we talk about poor or impaired management of patients or saliva. In normal adults, the rates are reported as 1 mL per minute. In children, it's pretty much half of that, 0.5 mL per minute. In children with cerebral palsy, the research shows it's pretty comparable. It's 0.4 cc per minute, which is essentially the same amount. So the problem is not the rate or the amount of solution. It's the control, the containment of this solution in a normal or healthy way. And when we talk about what is it, or what is that cutoff, and we start worrying about prescriptions, one definition way back in 2005 was when our caregivers have to suction our kids with respiratory or tracheal prescriptions or laryngeal prescriptions 10 plus times a day, or they just report copies a month, easily visible to the gross eye. That is where we say severe drooling and severe patient management issues. This is a very simple, you know, where the private glands are. The important thing to remember is there's some structure that divides the superficial and the deep lobe, the facial nerve and vein that separates the two. The submandibular gland wraps around the mandible. And then the sublingual one is right under the pons. We don't necessarily inject that. There's some ducts that carry the secretions into the oral cavity. The important thing, again, is the relationship of the muscles when you're trying to avoid adverse effects, especially with injections. You need to know your anatomy. The metatarsal muscles is in front of the parotid gland and the sternocleidomastoid is behind. And I know we already know all this. The function of saliva, when we talk about saliva control, the goal is to reduce the amount, but not get rid of the secretions altogether. So there is some healthy amount that we need to keep our tissues, again, healthy. Or make sure we're avoiding infections from bacterial viruses or fungal agents. And make sure we avoid any type of alterations so that moist, healthy mucus is what we need. And mucus has a function as a lubricant when it comes to swallowing the bolus formation and moving the bolus into the, again, upper GI system. Mucus has a function when we talk about feed production. So we need to remember, overdoing saliva management may also be a problem. In terms of what conditions we see it in, in adults, it's a motor neurone disorder. Parkinson's is a very well-known one. ALS is the second one. In children, of course, PP with the prevalence of PP in children, the numbers quoted are pretty high. One good source I will always refer you will be the AACPVM Care Pathways. They have some good publications. And when they came out with the Silurian Care Pathway in 2016, they reported some numbers. And I still use these numbers because there's not been any new updated information on this. So based on this, 40% of children or youth with PP have problems with saliva control. And when we talk about school-age kids, and this is a cohort we deal with on our outpatient side a lot, because even the anterior drooling in that age population is a quality-of-life issue. So when we talk about 68% of school-age children with PP having this problem, that means there's a need for treatment or better management. And, of course, other neuromuscular disorders, any type of complex airways, cage, vent kids, it's important to feed these kids and control their excretions so hopefully they can be weaned off their ventilator support and they can keep their upper airways healthy and clear. The Silurian type of physiology is multifactorial. That's why when we talk about management, we need to be addressing it in a multi- or transdisciplinary manner, and we need to be addressing different impairments. There's a sensory component. There's a motor component. There's a cognitive or intellectual component. But the main reason for the outcome, the end point, is there is impaired control or motor control, except in the dyskinetic case. The salivary excretion rate is pretty much normal. The amounts are pretty much normal. It's the way we use our neurosystems to keep the saliva in the structures long enough, and then the way we swallow it and get rid of it is where the dysfunction is. So the only exception to this is a dyskinetic PP based on some research back in 2009. The rate can be increased, but for the most part, that's not the case. And when we treat these patients, we need to be addressing it from a very systematic way we need to use. If there are dental structures, if there are upper airways, nasal structures, if there's head and trunk control, we need to be addressing. If there are medications, the polypharmacy, some of our kits are on. And, of course, there's always the good old gastrointestinal reflux that contributes to saliva. And I will come back to this over and over. One of the first questions you ask your patients when they come to you with drooling issues is about their reflux or GI symptoms. Read in 2012 came up with a good study. It showed us the associated factors when the functional motor impairment is more severe, the thyloria is more severe. So with the CP cohort, at least the presence of seizures, the poor head, neck, the presence of intellectual disability, eating speech difficulties. These are all associated findings in this cohort. Now, one big takeaway message from this talk should be, and I already know you know this, but I think it's really important to emphasize how we approach CT as a diagnosis in our patients and how thyloria plays into this. So cerebral palsy is a multi-organ dysfunction. And this was a good study in 2021 published that showed the association between the system, the respiratory system, and then the GI system, and also the swallow reflex of the teeth into respiratory canal. We all know the largest, the most common cause of premature death in our CT cohorts are the respiratory diseases. And dysphagia or impaired swallow plays into this. And dysphagia is very common, occurring in 43% of all children with CT, especially with degeneralized CT. And when there's intellectual disability, pretty much every single kid that has this severity will have problems with swallow and dysphagia. And videofluoroscopic studies show there's proven or videofluoroscopically proven aspiration in up to 70% of children with severe CT. Sometimes it's silent, and it leads to aspiration when it's silent, and it's not always as clearly identified or labeled. But this is one of those findings that we need to be suspicious of when our patients present to us, especially if they have severe findings of CT and intellectual disability. Now, aspiration is the main cause of respiratory symptoms and pneumonia when we talk about posterior drooling, and that's why we need to be managing thyloria much better. Complications with aspiration, if it is posterior drooling, it's the aspiration that leads to chronic change, respiratory infections, and progressive lung disease. And with anterior, of course, there are some complications that impact quality of life, participation in society, and causes problems with speech production or dental hygiene, may eventually lead to failure to thrive and dehydrate. Now let's talk about assessment. There are some subjective assessment tools that have been in the literature. The two validated tools, the two reliable tools, are the drooling impact scale, which was introduced by READ in 2010, and then the drooling quotient. There is a 10-minute and a 5-minute quotient. These two would be the ones that I would recommend using in your practices if you are looking at building a team or clinical pathway. The drooling impact scale is a 10-question type of tool where you ask the caregivers about findings associated with the drooling. So questions are focused around the frequency of the drooling, the amount of drooling, how that impacts everyday life, quality of life, how that quality of life is impacted for the child, but also for the family. And the scoring system is from 1 to 10. And then the drooling quotient, initially it was a 10-minute quotient that was then revised and validated, and the 5-minute quotient is where you have two trials, each interval lasting 5 minutes. So first you assess the drooling in a resting state, where the child is just resting quietly, maybe watching TV, but not really actively engaging in any type of movement or activity. And the second interval of the 5-minute trial will be when the child is actively engaged and actively drooling. So the total number of trials will be 20, and the amount of intervals where you record presence of drooling or new drool, which is the saliva escaping from the anterior margin, will determine the percentage and will give you the quotient in terms of the severity of drooling. Now those are the subjective assessments. The more objective way of doing this is using the instrumental assessment. Video fluoroscopic or modified barrier fluorostudy is the most commonly used technique, and this has some benefits, but there's also some disadvantages to using video fluorostudy or barrier fluorostudy to assess drooling or secretion-flush dysphagia type of problems. The gold standard, the first line for instrumental assessment when it comes to secretions, is the flexible endoscopic evaluation, which is the PIECE technique. Usually this is done by ENT physicians. It can be done by any MD. It can be done by speech therapists, I find, in Statoff, Massachusetts. So there's some training, obviously, needed to do this. This is where a very thin transnasal endoscopic test is done. So when we compare the two assessment tools with the video fluorostudy, you see all phases of swallows, including pre-swallow, during swallow, and post-swallow. With PIECE, unfortunately, you see the pre and post. So just during that few seconds of swallow, it's a blackout or white screen. But again, it has a purpose. It gives you the amount of secretions that are still remaining or residual or that are aspirating or spilling over. So depending on what you are targeting, you need to compare benefits and risks and then decide which one is the way to go. Now, one thing to remember, if your patient is NTO, I have a big patient population that I'm following out of a long-term acute care facility where kids are admitted for feeding therapies and most of them are NTOs, they're on the vans, they have traits. To me, it's very challenging to find the skill set it takes for these kids to be able to tolerate the skill so that our speech therapists can go down and do the modified bioinfollow. Whereas a feed study would give us the results, the information we would need in terms of whether they're breastfeeding with milk or if they're secretions, we're trying to trace and see the amounts and break them so we can come up with some decision-making. So when it's about secretions, I say feed is the way to go and this is the scale that was introduced way back in 1996 that we used to grade the amount of secretions based on the feed study or the posterior drooling evaluation. Then you have secretions outside the laryngeal vestibule that are easily cleared with swallow. So you see this with your scope when you look down, patients swallow, the secretions are gone, that's a greater one. If the secretions are actually deeply pooled and they're not able to be cleared with a serial swallow reflex, it may be gone anywhere from two to three. Three is pretty obvious copious secretions and the patient is swallowing three, four, five times and they're still staying there in the vestibule and sometimes are going down as an aspiration. So these two figures here what you see with the feed, this is the scope view that shows you number one is the vocal cords, number five is the tip of the epiglottis, number three is the fold, the epiglottic fold, number seven is the preformed recess which is easily filled when secretions spill over and with a grade two or three, this is where you see all kinds of bubbly secretions with your scope when you do your feed and then after the swallow, you see how much of that is remaining behind. And this is just a fluoroscopic view taken during actually a feed. So it just gives you an idea to compare what are the structures or what are the differences when you are doing these two tests. Now let's talk about intervention. The way to approach it is at least is what I would recommend when you accept your patient. Once you come up with which one is the major contributing factor, which type of drooling is causing the problems in your patient, then you can start planning your treatment. We always start with non-invasive. So speech therapy, swallow therapy is of course our number one or first slide to go. When we talk about anterior drooling behavior therapy, I will get to this shortly too, as shown to provide some benefits. And then comes the pharmacological or medical treatments, including orals or injectables or systemic medications and injectables. Oral appliances are not used as much anymore. We will, you know, shortly mention that too. When it comes to adults for costive drooling, radiotherapy is mentioned in the literature. Definitely doesn't apply to pediatrics. And when it comes to surgery, that is the last resort. And unfortunately, even after surgery, there's a portion of kids that still struggle with a rebound or a fissure coming back. And you still have to go back to your medical or injectable options. So let's talk about speech therapy. This is when therapy management, oops, sorry. So far, everybody is able to hear me. And I don't have to worry about checking the chat at this point, I guess. So let's talk about the therapy management. This is where your speech therapist comes into place. There's some research that supports what they do. Positioning is the number one thing. And this is something we need to address as pediatric rehab providers with our patient population anyhow. So proper biomechanical alignment, whether it's their seating system or the positioning of the head using different ways. Modalities, external devices, and educating the parents. There's also some research that shows stimulation, what the speech therapists do every day when they see our patients with their follow therapies, the oral stimulation using different modalities, different textures, different sensory gradients, whether it's icing, brushing, vibrations, and manual oral manipulation that aims to control motor and sensory pathways does have a benefit. Unfortunately, the literature shows it's a short-term benefit, but it needs to be carried on. That's why we emphasize home exercise program with our caregivers when we admit them to our swallow program. Oral motor exercises can definitely improve job stability. Dr. I, I think something happened. We can't see your slides anymore. Can you reshare them? I can try. Okay, let's see. Do you see it now? Can you see it? Not yet. Okay, let's keep trying. Okay, let me go back to this. I don't know why it doesn't share that. Hold on. Okay. I don't know what's happening. Okay. Go back, share screen again. Sorry about this, guys. This shouldn't be this hard. Okay, how about now? Can you see it now? Yeah, they're back up. Okay, so therapy management. We talked about positioning. We talked about oral stim, oral motor exercises. The one that I want to mention today, I don't know if you ever use this, but this is a modality we found very helpful when I started this clinic with my therapist back in Texas. So laser taping, therapeutic taping has shown to be beneficial for providing the stability of the mandible. It provides sensory awareness, and it also helps with the motor control of orbicularis oculus muscle. So this is one of our kids. This is very easy to do and instruct and educate parents. There are different approaches, but this is the most common one. And sometimes it's a challenge to keep it on with the anterior drool, but for the most part, it's easily replicable at home. It just takes some training. Now, the other modality that I would like to emphasize today, knowing that there's very limited research behind it, but it is commonly used, and it's just one modality like anything else in our school menu. It's the neuromuscular electrical stimulation, the vital sense. So this takes some special training for the speech therapist. So it's a certification program. You need to be careful selecting your patients. So it's not for every kid that drool. The goals need to be realistic. These kids need to be assessed properly. They need to have an intact swallow reflex. The goal here is to strengthen muscles. So again, educating parents and other providers is really important. And monitoring your response so that you just don't start this and keep them on it for months and years. It's really important to keep this in mind. Now, there's some research that shows it does work, especially with motor recovery. And there's some case theories that suggest it is effective. I have personally found it to be helpful. And in a portion of my kids, I would say 50% of our kids that we admitted to our intensive outpatient therapy for drooling purposes. This was one modality that we would use. We would try this for up to three months, and then re-eval them whether it's with their subjective or with our objective mental assessment tool. So again, like anything else, you need to know what you're doing, why you're doing it, and which patient would benefit from it. Behavioral therapy on the anterior drool side is, again, important because it does help with awareness and increases the frequency of some actions that would help with quality of life. So this is the vital stem, the vascular electrical stem. This is the electrode placement for different muscle groups that would help aid with strengthening different patients, different placements. It's very well tolerated. And if your speech therapist is trained, it's a very easy, noninvasive way of doing this. Now, oral devices, the best study came out of Australia for this. Unfortunately, in our practices, this is not very realistic. It's good for only a selective handful of kids that have cognitive abilities to be able to tolerate and cooperate this. You start with a short duration wear, and then you have to advance it. Usually, then it's advanced to overnight. And as you can imagine, it's hard to tolerate, and it's hard to find an insurance company that's going to cover this. But when it's used properly, if you can have this as an aid tool, it may work in this selective group of patients that can wear it and use it for awareness and oral motor control. Now, let's go back, or let's talk about medical management. And as we go along, we will definitely go back to some of the goals and how we decide on what medication. The fact is, unfortunately, back in 2012, Cochrane Database Review showed that there was a lack of consensus in regards to the most effective standard of care when it comes to medical management. And today, unfortunately, again, this is still the case. There's no consensus. So it's very individualized, and it depends on your comfort level or competence level, and it depends on, again, the infrastructure you're practicing at. So the goal is reduction in the amount of saliva, knowing that it's not the amount that's the problem. The approach is, we are trying to reduce the amount by 20% to 50% would be my rough estimate. We don't want the oral cavity or upper airways to dry. When we use medications, we can overdo it and easily cause mucus clogs, which may actually be more or as dangerous as the copious amount of patients that are aspirated. So it's such a fine line, and it's a challenge to find that balance. It needs to be only one component of this multidisciplinary approach. It's a step-wise, individualized approach. So not every patient comes in, and you use the same medication, the same amount. So there's some silent error. There's close monitoring. There's collaboration. And hopefully, you'll get the results that you're aiming for. And there's good research that supports what we do when it comes to medications. The betastropin and the botulinum toxins, both A and B, were studied and compared to placebo, and there was a significant reduction in the frequency and severity of drooling in the population with neural disorders, including CP. The common medications, and I know you're all very familiar with glycopyrrolate, and I'm sure you've seen it being used by other specialists. That's the first agent that was approved in 2011. Oops. Chat. Yes. Yes, thank you, Amy. Dr. Canale-Parent had some information on the chat. So the amount, how do you dose this? With the FDA approval, there's a recommendation for the age group 3 to 16 for neurological chronic severe drooling, usually initiated at a dose of 0.02 milligrams per kilogram. And it should be dosed multiple times. Once you start once a day, you titrate it every five to seven days. It takes a couple of weeks to get up to that optimal dose. The maximum dose is reported as 0.1, or 3 milligrams total per dose. When I practice using glycopyrrolate, I'm not always as precise. So it just depends on all the individualized factors. I go a little bit. I'm more careful and cautious with my kids that are on the vent with their mucous bugs, and that have obviously the tracheostomies in this bag. And if they have a good cough reflex, I may be a little bit more generous. So again, please trust your clinical judgment and your physical exam to come up with the best decision in terms of dosing. As long as you know your maximum, your safety margin, it's one of those medications, first-line medications. Now, when it comes to the patch, we know it delivers 1 milligrams over an extended period, three days. Sometimes it's used twice a week. I have used Telsa patch. Not that you can cut it into two, but you can put it on and peel off only half of it to begin with. And then you can advance it from there. And in the adults, Benzotropin is the one mainly preferred. Oops. Okay, let's advance the slide. Now, the other agent that I use in my patients, just because my patient population has also a lot of tone issues, especially if they have dystonia, if they have mixed tone, where I see a lot of dystonia type of findings, and they also have drooling, 3-hexapenidyl may be a good option. Yes, it's anti-polergic. It has a lot of side effects. You need to start low. You need to go slow. And if they can tolerate it, the maximum is reported to be around 10 and even 20 milligrams per day. If you can ever get to those doses without causing any side effects. You have to go very slow and monitor it closely because of the misocytes or anti-polergic effects, I guess. One agent I use a lot is Atropine drop. It's ophthalmic drop, 1%. It can be administered under the tongue or intraoral. You just open the cheek and put it in there. It's very quick onset. It's short acting. And there are advantages to this and disadvantages to this. But at least for those school-aged kids that have some issues with their quality of life, participation, and spoiling and waiting their alternative communication devices, and they can't be sustained in school because of all these issues with anterior drool, Atropine has been a lifesaver. And then I'll present a case in the end. Families like it because it's short acting. They know how long it'll be on board. And it's relatively safe. There may be potential side effects, but they're very reversible and not always systemic effects. So it's an option, again, one to be aware of. And usually it's based on the weight again. If your patient is less than 20 kilograms, it's recommended to start with one drop and then you eventually build it up to three times a day. If your patient has a weight of 20 kilograms or more, you can start with two drops, one on each side, knowing that, again, low titration, the effect is usually less up to six hours and not beyond that. So that six-hour period may be good for school, during school, or overnight, but something to remember. Now, an agent that is very commonly used by the pediatric pulmonologist, I find, is the ibuprofen spray. I honestly, personally, don't see any success with that. They usually come to me on that with no response, and I know there's some literature in the Parkinson's adult population that really does not show any objective reduction, but I just wanted to include it there. Now, what we need to remember with all these medications is the side effects, the adverse effects, and how very easily you can push these kids to the other side by causing those side effects. So, we have literature that shows after one year of treatment with anticholinergic, 81% of the patients stop using the 3-hexafenadil due to constipation, due to urinary retention, food rise, mucus spikes, whatever it is that comes with the anticholinergic effect. And the same race, 82% stop using the patch, 63% stop using the glycopyralate. So, these are big numbers. I think the key here is to remember, you start with a very low dose, you go very slow, and you monitor. And other side effects with this group of medications is the behavioral changes. I've seen this happen. It's dose-dependent in my case or in my practices. When I see it, I lower the dose, and usually it's reversible. And everything else mentioned here is common knowledge to you all. Now, there's some alternate treatments recommended. The modafinil is the one that acts at the brainstem level. It's more in the adult population where the dosage is higher, like 200 milligrams. Today, it was a different indication that started the use of this medication, but it is also used, you know, sporadically for thyroid cases. In the pediatric population, it's not one of my medications that I choose to use, but it's out there if you want to try it in the older kids. One good thing is it does not have the anticholinergic effect. Now, one big medication group that I will keep mentioning is the reflux medication. So, it doesn't matter what dosage, what medication you use on your kids for drooling purposes. If they have ongoing reflux, that is not well managed. So, there's that sedentary reflux that will be triggered by esophageal reflux, and you need to be on top of your game with your kids. You need to be always asking, questioning how they're doing with their reflux if it is present. Just knowing that they're on some medication for their reflux is not good enough. This may take some digging to get that information out, but I can't emphasize how important it is to make sure they're being treated for this. The other two mentioned here is the natural extracts. There's not good research or quality research to support that, so I don't really use that. And acupuncture, the only research I could find was a very, to me, was a low-quality study. So, it's not very convincing to me, but it is being used by different providers. So, injectables, the botulinum toxin. This is one of the common modalities or medical modalities that we use. The important message here is how we do this. How do we go about injecting glands, and what glands do we choose to inject? There are different extracts out there, but one thing to emphasize is knowing that the mandibular gland is the main one that is creating the saliva at a resting state. We need to be targeting those glands when we talk about neurotoxins. Parted glands, yes, they're bigger, and they do take over with stem, so it's a good idea to address that, too. But my own practice, when I inject, I do all for glands. And the different types of toxins available, there's the FDA approval for the income botulinum toxin, which came in the pediatric population back in 2020, December 2020. For adults, it was FDA-approved back in 2018. The RIMA was approved only in adults in 2019. We also have the other available botulinum toxin, which is off-label use, and I'll be mentioning the dosages in the next slide. So, we all know the botulinum toxin takes a while to kick in, up to two hours. The effects are actually more obvious starting around week two. Usually, it takes up to four weeks to see a good response. The lasting effects may be up to six months. We usually say three months and four months, depending on the toxin we choose, but in practice, I've seen the effects lingering with home exercise programs, ongoing therapies, other modalities. In addition to the toxin, the injection frequency or interval is usually around every six months. But, of course, there are individual variations with this, too. And the research shows it's greater effect than the propylamin when it comes to comparison side effects. Now, if you inject the muscles, if it diffuses out to the mastication muscle, then, of course, there will be weakness. It may impair your swallow due to the weakness. The saliva may be thickened. So, one thing to remember is how to educate or prepare your patients before you do the injection. If they're on the polypharmacy, including they're wearing the patch, they're on glycopyrrolate or pre-infected panadol, and now you're adding injection to this, you need to start tapering down with other medications so when your botulinum toxin kicks in, they're not too dry. They don't call you back saying you're now seeing little spots. So, again, it takes some coordination, some good planning, and education. Please remember with any type of botulinum toxin, systemic effects are always a possibility. So, and then the local effects of the injection itself. So, there's some good research out there. A systemic review, which was more recent in the pediatric population, showed dysphagia as the most common side effect, but the good news is it was reversible. It resolved. A renal neurotoxin is temporary. The way it was injected with the onobotulinum toxin, two glands or four glands were targeted. When two glands were injected, the total amount was the 50 units of onobotulinum toxin. When four glands were injected, the total amount was up to 100 units in one injection, and this was the amount that was deemed safe and effective. Let me see, there's something on the chat. Yes, thank you. Thank you, Amy. So, one thing to remember with previous research, it shows a diagnosis of TP itself compared to other disorders. Like, let's say you have a kid with a seizure disorder or with some genetic underlying syndrome that has ruling that you're addressing. When it comes to TP, there is an association with decreased adverse effects, especially if you're using a high dose of the neurotoxin. So, the higher dose we find is up to 30 units per gland onobotulinum toxin, was shown in the study to be an independent predictor of adverse effects. And then the pre-treatment ruling quotient, which is less than 18%. So, we just mean they are not in the severe category. The adverse effects may be worse. The volume is one big factor that you need to remember when you're talking about glands, injecting glands. The dilution is important. If you are injecting greater volumes, the chances are you will run into adverse effects. So, controlling your volume is one big factor. The dosing, there's some good research that guides our practices. If your child is less than 15 kilograms, usually the rule of thumb is 50 units per gland. If your child weighs more than 25 kilograms, again, it's 25 units per gland. And the maximum amount would be up to 100 units total for four glands. That's a good guiding dose for new injectors, especially. Now, children with TP with the RIMA-C toxin, the total amount of 3,000 units into the cellular glands significantly improves the frequency and the severity based on this one study. So, that's the recommendation that I use in my practices, and that was also mentioned in our consensus publication in 2021. Now, the ABOR botulinum toxin, the pediatric TP population between the ages of 21 months to seven years, the amount that were studied were 100 units to 140 units into the parotid glands was reported to be safe. So, when we inject, it's important to remember anatomy. The one thing to remember is the parotid glands is right in between the musculature and the sternocleidomastoid, which you are going to be avoiding. And then there are some important vessels. Remember with the parotid, the superficial and the deep, you need to worry about your facial nerves and artery and vein. The consensus statement, which I was a part of, Dr. Volo was the main author who put it all together, and there were multiple of us contributing to this, was very helpful in my practice. And so, this is one good article I'm going to refer you to. What this consensus states is ultrasound guidance is the preferred method to get the best results and to avoid adverse reactions. And the initial starting doses for ABOR botulinum toxin is one unit per kilogram per gland, and the maximum is 100 units total. Pediatric dosing information for ABOR botulinum and RIMO-D is limited. Adult studies have demonstrated good efficacy with 50 units of ABOR botulinum per gland. Pediatric studies show tolerance to 100 units per kilogram per gland, up to 3,000 units with the RIMO or B botulinum toxin. Volume is an important factor to remember. The volume of the botulinum toxin you're injecting to the gland should be limited to 0.2, 0.3 ml per gland. So, please remember when you plan your injection cycle, the volume is as critical as the gland and the guidance and your total dose. So, this is just a really quick visual to help you. There may be experts here in this audience too, but when you use ultrasounds, it just gives you that confidence. You know where you're injecting, and you're confirming you're injecting in the right place, and you're avoiding those structures that you want to avoid. So, it can be out of plane, in-plane, based on your comfort level and your training. So, future directions in terms of how do we improve our practices around thyluria. We need more quality evidence like anything else in rehab in terms of dosing, safety, and outcomes for the treatment modalities we choose. We need to develop consensus on medical interventions used in children. So, first-line medications, first-line treatments, how to dose them, how to monitor them, what type of outcome measures we need to use, and we need to be able to tease out the control groups and the effects of therapy. When we talk about this multi-model or multi-synergistic, multi-disciplinary approach, how much of the benefits we're seeing are due to the therapeutic intervention versus the medical intervention type of thing. And, of course, new program development using objective measurement tools and outcome metrics is needed. I'll tell you, it is a challenge when it comes to practice development. I started this back in Texas with my ENT colleagues and my speech therapist. I'm a little bit more challenging in Boston, trying to find the right teams and the right infrastructure. It is very doable. It's very rewarding. So, I would definitely encourage all of you to look into this patient population, knowing you can make a difference in their outcomes, whether it's medical or health-related outcomes or quality of life. And I included references. The best reference and the most reliable resource will always be the AAC PDM, the OK Pathway. This was back in 2016. There's no new updates at this point, but it really puts this into perspective. And if you're especially starting a new program, this is a good justification for your payers or for your leadership. So, before I go to the two cases, any questions? And how are we doing with time? You can put it in the chat. You can just speak up. Okay. I'm not hearing anything. So, I'm just hoping this... Oh, I was going to say thank you, Didem. That was great. If I could just ask one question. When you're assessing patients, do you have an objective measure that you use before and after? I think for our institution, I've been using and trying to get more standardized the teacher drool scale. I was just wondering if you guys have one that you particularly like. So, we ended up choosing drooling impact scale. It was very accessible, easy to do, very efficient, safe, effective. And my speech therapist did it. And we did it through our therapy time point. And it's a validated tool. We also use... We have it available to us in the clinic. Our speech therapist did it with the ENT surgeon. I was also there. I did not introduce myself, but I was there to interpret. So, those were the two tools we chose back in Texas, D and the drooling impact scale. And we found it very helpful. Great. Thanks. Okay. Thank you. Anybody else? Dr. Ai, this is Nick Flynn here. Thank you for the great presentation. I was curious about the volumes. You're recommending they're right at the end of a 0.2 to 0.3 milliliters per gland. Is that because there's concern for gland destruction or unintentional spread or both? It's mostly the diffusion, the spread, unintentional spread. There are small glands, especially given the age group that we do this in, it's more the diffusion than the gland itself. So, at some point, honestly, one of the goals is to help shrink those glands. And there's also some studies that show the glands do shrink after repeated injections and prolonged use. But that's not necessarily a concern. The concern is more the weakness, what we call the side effect or adverse effect of this injection. When you do the injection and your patient ends up with weak chewing muscles or weak swallow. So, the volume is more crucial in terms of that issue. Is there anything else? Doctor, this is Amy, and thank you so much. Are you doing these in clinic and how do you ensure just, how do your kids tolerate it? And what have you found to be helpful when you're doing these in practice? You mean the injections itself? Yeah. Or the feed? Like the injections. So I do it in different settings. I do it in outpatient. I do it in the post-acute admission stage. And for the most part, they do tolerate it well. And I have kids that I use conscious sedation. I have kids I've used, well, I've done it under general because I'm also injecting other areas, other muscles in addition to the glands. So it just depends. But in general, I find it's very well tolerated if you prepare the family well. And in the beginning, it helped me to do some of these sedative approaches. But once I got more confident with my ultrasound and how to coordinate this and make sure I have that nurse helping me position the patient, it is doable. So I have one question on the chat. Can you share a little about coordinating timing of Botox when you're doing it for both thyroid and spasticity? So I do it all at once. When you say timing, the challenge I had when I first started using it was coordinating it with my ENT surgeon. I would get patients sent by them to me for this purpose. And they have already injected the patient. And then they were also asking, can you now inject the patient for their spasticity? And then next time it's time to inject, you take over. So to me, I found that ENT surgeons are not as concerned about the interval of injections. I time it based on their needs. If their spasticity overrides and they can't wait six months, then I'm going to do it every three months or every four months, depending on the patient. I don't like to do it more frequently than that for cellular gland injections. But I do it all in one setting. And if it is not just the gland, if it is multiple muscles, then of course, sedation, general anesthesia is the way to go, at least for my practice. Does that help answer your question? Okay, wonderful. Okay, let's talk about the cases. Let's do this interactive. I did not include CT patients here because, you know, CT is a common diagnosis, but I just wanted to point out, there are other diagnoses you will get when you start practicing thyroidia treatment. So this 60-year-old boy came with a diagnosis of a genetic mutation called vanishing white matter disease. He presented with spastic quads, dysphagia, intellectual disability. He was seen in our clinic with me being there and my speech therapist being present. We opted to do the fees. We pulled in the ENT, did the fees, and we came up with a community grading scale of two, grade two, which is deeply pooled secretions outside of the vestibule. Patient's mom also reported he was receiving deep changes 10 times a day. Patient had already tried home health feeding therapy. However, the home therapist basically reported the progress was very limited and was the one who initiated this referral. So, any concentration with this kid? If you don't see the anterior stool, then you look at this picture, but let's see these shots. Grade two of posterior stool. So again, just because they don't have the anterior stool doesn't mean our patients are coping well with their situation. So that's one thing to remember. And if you want to quantify, fees is a good way to go because that will help drive your decision-making. So this is before you start your treatment modalities or your medications, and then you'll be able to compare it to cost. So anyone wants to jump in and make some suggestions? Again, there's not one right way of doing this. It's a multi-modality approach. So any idea is good. I don't see anybody in. So let's look at what we ended up doing. So we started this patient in our outpatient, intensive outpatient twice a week. We called it intensive so that we could get them in more than once a week. So that's our payer policy. And this patient, a total of 27 sessions, neuromuscular electrical stimulation was done after a speech therapist did the evaluation, confirmed the presence of flat facelift, meaning intact peripheral nerve. We used the pharyngeal and facial placements for the vitals. Our speech therapist also introduced taping. They did oral stimulation, pulling of lip, buccal stretches, centrist in programs and modalities. They did POT, and most importantly, they aided the caregivers and the whole program. So the impact scale was 82 on this kid before the start of the treatment, outpatient treatment with modalities. At discharge, at the end of those 27 therapy sessions, it was 62. Carrying out the home exercise program. And we repeated the impact scale. The score was now 53, and mom repaid by 58. So this did not resolve the problem. But again, our goal is to reduce the amount of situations by 20 to 50% and to impact their health outcomes and their quality of life. So to us, it was an acceptable, successful outcome. Next slide. Okay, here is a briefly description of surgical treatment and evaluation of the patient for surgery. So single surgery would be when, how, when, where, how, and just treatment. Not in any terms of the tertiary or post-operative. Then we move to our primary surgeons. The patients that we may see more of them early on if they're going to have a surgery. They're not going to be in treatment for months. They're going to be in treatment for months. We send them over to the clinic. We need to really, you know, I would take those first. We would try to send them to the clinic. And we will try to get them to the clinic first. So this is the patient. It depends on your practices or your surgeon. Now, surgical techniques. Like, when we make you stand on your surgeon and this is my, they supposed to do that. But fortunately, the way, the end of the surgery is up here. Also, these kids are actually probably, they fortunately are six weeks in turn. So, the treatment is not for them, but it's good to know that. So, usually, the best thing is my kids and I'm having a hard time with the sound. Is anybody else? I am too. Hear me now? No. Say a couple more sentences. Okay. No. I'm sorry. Should I read the case? Yes, please. Oh, actually, you sound better now. Okay. Okay. Yeah. So, obviously, all of you, I apologize. I don't know what's going on, but I'm in a hotel room. I'm going to blame it all on this hotel. But here's the next case, a 10 year old. You just saw the picture here. Here's a bunch of drool, hair drool. The way we look at impaired, side view. 10 year old with intractable genetic mutation leading to epilepsy syndrome. He has a vagal nerve stimulator in place. And with that, we were still able to use the neuromuscular electrical system, by the way, because it's not a contraindication. The mom reported five fluid changes a day, but two pillow cover changes at night due to soaking from secretion. So you can imagine the impact on quality of life. He was previously treated with some medications, the Sofamin patch. And at the time of the eval, he was on the glycopyrrolate, one milligram three times a day, which is a pretty big dose. And there was no response reported at that point. The patient was not receiving any therapy, and we got him. So anything else you would try on the patient? I did. It doesn't, knowing that it's not going to fix the problem, like most of the medical conditions that we treat in our rehab world, giving it a best start with our management efforts. We talked about the limited duration, but some effects of the Atropine drops. So we started him on the two drops. He was more than 20 kilograms, and we opted to twice a day. He was also admitted to our outpatient group therapy for intestinal saliva control work. He was started on the neuromuscular electrical stem. The taping was introduced, and the usual therapeutic modalities were tried by speed therapy. So initially the drooling impact scale was 70, and at the time of discharge, that had come down to 40. This was from the outpatient speech therapy, his score was 40. He was started on the home exercise program. At that point, he needed three big changes versus a 10, with no nighttime soaking off the pillow. Mom felt like Atropine was helping overnight more than anything else. So here's the role of Atropine, knowing that it's short-acting, it is still impacting their quality of life. And mom continued with taping during the day to help with some of that sensory awareness and motor control. And this is it for today. Helpful summary and research for you to go back to when you see those pictures. And please don't hesitate to reach out if you have any interesting cases. Very happy to discuss them with you. Thank you.

pediatric drooling

assessment

treatment options

multidisciplinary approach

speech therapy

medical management

botulinum toxin injections

dosing guidance

injection techniques

tailored care