Ketamine Chronic Use in Children


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Oral Ketamine for Children with Chronic Pain: A Pilot Phase 1 Study

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From 2013:

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Participants were given 14 days of oral ketamine, 3 times daily, at dosages ranging from 0.25-1.5 mg/kg/dose. Participants were assessed for toxicity and for pain severity at baseline and on day 14 of treatment

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Of these 12 children, 5 experienced improvement in their pain scores, 2 with complete resolution of pain, lasting >4 weeks off ketamine treatment.

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Ketamine for Pain in Adults and Children with Cancer: A Systematic Review and Synthesis of the Literature

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From 2013

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Neurocognitive Changes after Sustained Ketamine Administration in Children with Chronic Pain

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From 2015:

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This prospective, uncontrolled study describes the neurocognitive functioning of 11 children with chronic pain before and after 2 weeks of daily oral ketamine exposure. Neurocognitive assessment was performed at baseline, Week 2, and Week 14.

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Neurocognitive assessment was performed at baseline, Week 2, and Week 14.

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This study did not detect any decline in neurocognitive scores in a small number of children exposed to 2 weeks of oral ketamine therapy. Randomized, controlled studies of the neurocognitive effects of ketamine in children are recommended to further investigate these preliminary findings.

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Pain treatment with ketamine cannot be compared with an untreated control group, that would be inhumane. How do opioids change the brain? And how humane is it to treat severe intractable pain in children by starting opioids for the rest of their life, with monthly visits for opioid medication potentially for decades when we know opioids create pain, create inflammation, not to speak of possible addiction.

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Pain itself no doubt can create cognitive and behavioral changes. Opioids for pain and the many adjuvants may do so as well. Sleep deprivation is often an issue with untreated pain.

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For children with severe behavioral problems, violent, abusive, dangerous and frightening, how can they socialize, how make friends, and how does their brain and behavior develop with such untreated patterns as they are beginning to realize who they are, and realize how they may have permanently damaged everyone they know and love?

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And from today:

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The dark side of opioids in pain management: basic science explains clinical observation

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The Angelic face of Opium is dazzlingly seductive, but if you look on the other side of it, it will appear altogether a Devil. There is so much poison in this All-healing Medicine that we ought not to be by any means secure or confident in the frequent and familiar use of it.Thomas Willis “Medicine in Man’s Body” VII i 128 1848

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Have we all forgotten the dark side of antipsychotics given to children? What does it do to their developing brains and bodies, creating obesity and lipid disease?

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The material on this site is for informational purposes only, and is not a substitute for medical advice,

diagnosis or treatment provided by a qualified health care provider.

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Please understand that it is not legal for me to give medical advice without a consultation.

If you wish an appointment, please telephone my office.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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The advertising below is not recommended by me.

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Advertisements

PEA Vitalitus Micronized/ultramicronized superior


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From the Journal of Neuroinflammation comes this 2014 discussion of PEA related to the recent post on Vitalitus PEA product. PEA is micronized.

 

Micronized/ultramicronized palmitoylethanolamide displays superior oral efficacy compared to nonmicronized palmitoylethanolamide in a rat model of inflammatory pain

 

… PEA’s ability to modulate inflammation and pain in animal studies led to the proposal of this endogenous fatty acid amide as a component of a complex homeostatic system controlling the basal threshold of both inflammation and pain. The fact that PEA is produced during inflammatory conditions supports this role. Further, data showing selective inhibition of PEA degradation to be anti-inflammatory points more directly to PEA’s involvement in the control of pain and inflammation. As an endogenous compound, PEA has no adverse effects at pharmacological doses while possessing a double therapeutic effect (that is, anti-inflammatory and antinociceptive) (see [8,9] for recent reviews).

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This study allows me to be confident that the product sold in USA is as helpful as PeaPure sold in Netherlands.

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PEA is a glial modulator. It clearly modulates the TLR4 mediated inflammatory responses and dose-related inhibits inflammatory evoked TNFa and IL-1b gene expression. This and other mechanisms are summarized by Jan Keppel Hesselink in 2013.

 

 

 

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The material on this site is for informational purposes only, and is not a substitute for medical advice,

diagnosis or treatment provided by a qualified health care provider.

~

Please understand that it is not legal for me to give medical advice without a consultation.

If you wish an appointment, please telephone my office.

~

~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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The advertising below is not recommended by me.

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Ketamine in Bipolar Depression – A Review


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An excellent review of Ketamine, a rapid-acting antidepressant and anti-suicidal agent, in Bipolar Depression

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Efficacy of Ketamine in Bipolar Depression: Systematic Review and Meta-analysis. 

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Parsaik AK1, Singh B, Khosh-Chashm D, Mascarenhas SS.

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OBJECTIVE: To consolidate the evidence from the literature to evaluate the role of ketamine in the treatment of bipolar depression.

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METHODS: Major databases, including MEDLINE, EMBASE, Cochrane, and Scopus, were searched through October 2014, for studies reporting the role of ketamine in the treatment of bipolar depression. Only randomized controlled trials were included in the meta-analysis. We calculated standardized mean differences (SMDs) with SE for each study included in the meta-analysis. A random effect model was used to calculate the pooled SMDs. Heterogeneity was assessed using the Cochran Q test and I statistic.

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RESULTS: Of the 721 articles that were screened, 5 studies that enrolled a total of 125 subjects with bipolar depression (mean age, 44.6+/-4.3y and 65.6% females) were included in the systematic review; 3 randomized controlled trials (69 subjects) were included in the meta-analysis. The meta-analysis showed significant improvement in depression among patients receiving a single dose of intravenous ketamine compared with those who received placebo (SMD=-1.01; 95% confidence interval, -1.37, -0.66; P<0.0001). The maximum improvement was observed 40 minutes after the ketamine infusion. No heterogeneity was observed between the studies (Cochran Q test P=0.38, I=0%). The 2 studies that were excluded from the meta-analysis also showed significant improvement in depression after ketamine therapy. Individual studies also reported improvement in anhedonia and suicidal ideation after ketamine therapy. None of the subjects had serious side effects, and the side effects were similar between the ketamine and placebo groups.

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CONCLUSIONS: This study suggests that ketamine is effective in treatment-resistant bipolar depression and may reduce suicidal ideation and anhedonia.

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The material on this site is for informational purposes only, and is not a substitute for medical advice,

diagnosis or treatment provided by a qualified health care provider.

~

Please understand that it is not legal for me to give medical advice without a consultation.

If you wish an appointment, please telephone my office.

~

~

For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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The advertising below is not recommended by me.

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First Ketamine Patient – Opioids


 

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You must get off opioids to get pain relief, even just to see where you are. I am continuing the conversation started September 2 because I am being attacked for saying get off opioids if you want to try something that may take away your pain. When you tire of pain and tire of monthly visits for opioids the next 30 years, try something better.

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I should have placed this case separately, not at end of note. Here’s the link to that post:

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My First Ketamine Patient 

Ketamine in Outpatient Use

 

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Scroll toward the end of page to read it.

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Opioids cause pain. I’ve said that repeatedly on this site. They trigger pro-inflammatory cytokines in brain and spinal cord which causes more pain. See the links given on home page of this website and repeated below:

 

Please read my posts on May 26, 2009 on low dose naltrexone, dextromethorphan, ketamine and January 2011 on neuroinflammation and the innate immune system in brain and spinal cord to understand some of the new concepts in medicine on which I base my approach. There is much overlap between pain systems and major depression systems, in medications and mechanisms in the brain. Quite often what works for pain will work for depression.

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I am continuing these comments because of continued attacks I am getting. Why attack me for suggesting pain may be treated with something other than opioids, that you must first taper off opiates, for saying opioids don’t work for CRPS?

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That is based on years of clinical experience since the turn of this century. What is your attack all about? If you like where you are at, stay there. America and the internet is full of attacks and rage — tearing so many people apart rather than building something, going forward, working together.

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It’s your choice! Cling all you want to what fails to help. Why attack me? and why expect me to post your attack on this educational site? People come to my office and presumably read those two links on the home page, copied above, and read many many case reports and many pages where I repeat: opioids cause pain. That opioid mechanism is validated research, not something I made up. And sure enough, people can get better after they taper off. But choose carefully what you replace it with.

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Some make an appointment and later are upset in the office when I say I am very mindful of CDC guidelines. If you are on some cocktail or some dose that some doctor has ramped up, do not expect other MD’s to agree with it. Why not stay with that MD? or have they lost their license? Yes, I do prescribe opioids. They may not be the dose you demand, and sadly you will be a patient for life if you take opioids.

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For these last 15 years, this new century, I am seeing patients do better and start to improve only after tapering off opioids. Have I not also defended opioids, railed against CDC opioid dictates? Opioids are all we have for some patients.

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One major obstacle to any alternative is that opioids make billions for pharma so why would pharma be induced to make something that actually relieves pain? I cannot even count how many opioids have been approved by FDA since the turn of this century,

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Stop the personal attacks. Free speech is American – go use it somewhere else. Morons and vicious cranks have taken over the web. Free us from vicious internet attacks that have changed web discourse into no discourse in this country, and now spread to polarized political opposition. Take no hostages. sheesh! Your personal experience is one I have seen thousands of for decades. Failures all. Lifelong use is the best you can hope for. So accept it and stop attacks. I cannot fight CDC. I tried for months to advise, but you don’t think they will stop at the current restrictions do you? Has your insurer already stopped paying for your opioid? That’s next. Why attack me?

 

We are all aiming for freedom. Freedom from pain, freedom in the body; plants are aiming for freedom, animals, social mores are striving for freedom, and we are all aiming for perfection. I hope the work I do continues to be a contribution towards that. It is amazing when it works. But people call to see me, and when I say they must come off opiates in order to do this exciting work, I am personally attacked. Rather than attacking the idea, I am attacked. We cannot move forward until you are ready to try. No one is forcing you to do anything. Stay where you are, find the doctor who will do what you want. Yes, the CDC is pushing everyone; the rules on dosing will get tighter, but they have nothing to offer in its place. Insurance stops paying for drugs that fall out of the CDC range. Congress is not needed to rope in the 80% of the opioids in the entire world that are prescribed in the US. Insurers like saving money on opioids that cost a fortune. $17,000 a month for one patient for one opioid, not counting the other one or two opioids and the many adjuvants these patients are on. See the incentive?

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I have time to report a small part of many years of clinical experience in seeing the amazing possibilities of complete freedom from pain — that occurs only after patients taper off opioids. I have posted case reports on these pages. Give up the attacks and fears. Go for better. No one is forcing you. You don’t have to give it a try. But there’s nothing to lose if you try. You could gain freedom.

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CDC is now getting an inkling, howbeit from a wrong direction, what happens after decades of NIH and congress fail to fund clinical pain research. Clinical research. Failing to ignore the essential discoveries of the innate immune system, how it regulates pain, glia and glial modulators. Medicine ignores science until pharma comes up with medications that modulate glia. But these medications already exist! We are ahead of the process. But it would help to invest in clinical trials on drugs that are glial modulators and a huge help to discover more.

Hello? any scientist or pharmaceutical company  motivated to tear themselves away from the opioid epidemic — what other alternative is there, CDC? We have opioids. Can pharma open the curtain to their money making, and use all those lobbyists hired by pharma to influence politicians, FDA, CDC on better? Can’t government agencies think without being paid tens of millions by pharma lobbyists?

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Consciousness must be wider than opioids. It must include all the science on the innate immune system we have learned since glial research began 1991. Linda Watkins and her lab in Boulder Colorado and the worldwide collaborations form the most exciting thing that has happened to brain research in the last 100 years and it is so dynamic! Fast! It’s not like neurodegenerative diseases that take years or months to evolve before we see change. Glial inflammation is dynamic, instantly evolving and interacting with the brain and master control systems in the body. And the work likely will apply to slower degenerative conditions. Use medications that modulate inflammation in pain and depression to study more interventions.

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This inflammation is created by your innate immune system. We thought glia, these cells, were sort of like glue, holding neurons and structures together or something. Turns out glia are dynamic and we need to study them in vivo, in humans, using pain as an instant feedback mechanism. The rat studies are done. Dog studies done. Papers in place. Professor Watkins and Xalud Therapeutics need $20 million —$20,000,000 —to do the final clinical studies to submit to FDA for approval of the most exciting treatment I could imagine.

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Xalud has the anti-inflammatory cytokine IL-10 in the brain. You may become pain free for 3 months at a time with one injection into the spinal fluid, the CSF. IL-10 restores the anti-inflammatory balance in the brain and spinal cord, the CNS. Chronic pain is caused and/or perpetuated by a super abundance of pro-inflammatory cytokines. Also true of depression in rats, and schizophrenia in young teens who have early signs of schizophrenia.

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Pharmaceutical companies want to make billions in opioids. Fine, and let’s include something that actually helps too. I directly connected one owner of a pharmaceutical company. Small change for this multibillionaire. I failed: zero interest. He was completely invested in opioids for cancer pain. You know they want to seel to 50,000,000 with chronic pain, but FDA approved only for cancer pain. The money in fentanyl is making headlines because of street use. It’s all in the timing. Opioids had been riding a wave of highs, the pun is dead serious, epidemics of death spread like wildfire across the country. Now in the only clinic in North America where addicts can inject safely, they find 90% of the street heroin is contaminated with fentanyl. Fentanyl is 50 times stronger than heroin, your family members and friends are dying from heroin cut with fentanyl. No doubt that happened to Philip Seymour Hoffman, because fentanyl is easier to get on the street, surely it is famous for its high – all opioids are different, but addicts don’t know its power to kill. They don’t have a clue what the dose is. That’s the difference. Knowing its safety profile.

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All I am hoping is that now that fentanyl is riding a rapidly moving down the wave from its high after so many years, that one of the fentanyl making companies invest in glial modulators and hopefully in Xalud Therapeutics. Let’s get this important work off the ground. Professor Watkins has received awards from so many countries. She has been keynote speaker for so many annual medical and scientific meetings. Results are ignored by opioid companies and investors.

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We are ignoring the unharnessed power of the natural, dynamic system in the brain and how to quench the fire that some process has ignited. We can modulate and help to restore balance in the innate immune system. We need to understand so much more. We need glial imaging available only in Australia. All we have are opioids.  I am angry. I want better for all.

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I am simply shocked at the evil of the status quo. The money in fentanyl. The failure of our president and congress to declare an emergency in treating pain and treating substance abuse. Give glial modulators the research it deserves. Stop with all the wars on cancer already. How about a war on cancer pain? We need tools in cancer pain because that applies to all. There is no such thing as cancer pain. Cancer can cause all the same types of pain that osteoarthritis can cause, only the added burden cancer can also kill.

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When I was teaching cancer pain management at MD Anderson Cancer Center, one of the best centers in the world, I saw how serious was our inability to relieve extreme pain when not even the surgical procedures touched pain, not cutting the spinal cord in half, not  alcohol ablation of the lumbo-sacral plexus, not even slicing the small spot in the brain that would turn off the affect toward pain. The patient could feel it, but it did not affect them. They didn’t care about pain. Unfortunately, I hope I never see one of those again. The person was not there anymore. Their entire personality was missing and words fail to describe how awful that was. Obviously these procedures are done only in the last few weeks of life when death is certain and all other procedures failed including opioids.

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This country could fund pain research as part of the new war on cancer. Cancer pain, the one we all dread the most, is nerve pain.  People with cancer have the same types of pain as anyone else, and nerve pain is the most difficult to treat. It has been astonishing for me to literally see intractable nerve pain go into remission. Why for Pete’s sake do I want to waste more of the past 42 years in medicine giving yet another page to someone angry about opioids and attacking me for comments on these pages?

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Gene Wilder once said about why he was so against the acting business, he said: “I like the acting, I don’t like the business.” Pharma is a money making business. Business ethics are not the same as medical ethics. Why should pharma do anything but focus on money  making opioids? They will if CDC cranks down their money making machine even more. And they will, only because they will see it has nothing to do with addicts killing themselves. That’s where we are back to the fentanyl. Heroin laced with fentanyl that’s 50 times stronger than heroin. More and more middle class people will see someone in their family dead from fentanyl on the streets. Kids in grade school passing pills of fentanyl they got on Amazon.

 

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Chronic pain, especially nerve pain, is most difficult to treat. It is never all about medication. Never. You must also learn tools you can use. Even if you pain goes to zero, are you deconditioned? I am certain you’ve got muscles involved and they need help too. You may easily be thinking the pain from those muscle points are nerve pain. Nope. Muscle stuff must be addressed in the language that muscles speak. They don’t speak medicine language.

Work with a psychologist on CBT or DBT. A pain psychologist is not needed to learn tools to make your mind strong. We must all use those tools. We must all be strong. No one can afford to fall apart emotionally because we know that makes pain worse. Learn the tools to use or else pain. There is no surgery, no pill, no Valium or Xanax or Ativan that can make you strong — no crutch. The dark bunny hole will always be there. Nietche’s abyss – we are always walking over the abyss. Do not look down. Look up.

Once we know how to cope, we have tools we can use at any time. Same with muscles that have been inactive for years. Tools we all learn. The entire family together can be taught what it takes for physical therapy. We cannot help all people. Some in pain need family help to bathe and dress and remember home exercises.

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For CRPS especially, we want to prevent spread, mirroring, appearing in the other limb and distant areas. I like to think of treatment like a football game. You’ve failed everything known, that makes it potentially harder. Spinal cord stimulators, nerve blocks, every known pill and high dose opioids. But you’ve got to win this game. You have one guy running down the field with a football, how many guys are you going to send after him? What if 3 or 4 guys only partially help? Add that up and you may have extra 30 or 40% relief. Hit pain hard, use selectively chosen glial modulators and others with mechanisms on these pathways, get pain to zero – or give it the best chance to get it near zero pain. That’s the first goal.

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Nothing is perfect. Nothing in medicine is perfect. It is still an art, not a science. But it is a gift to be able to use these tools that I’ve selected to use together the last 15 years. It’s thrilling to see the science come out explaining even more the power of the innate immune system, the glia.

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Had the practice of medicine evolved, we’d have worked with, not against, the timing of the circadian clock in these cells to prevent postoperative chronic pain, or minimize sending the inflammation into overdrive. That is not happening. Medicine is not tracking with the science. Opioids damage the balance of inflammation in a system already exploding with pain. It would be a miracle if providers and patients ever stop reaching for opioids first. Do they even understand they are doing the opposite of  relieving pain, or care that better choices exist? Perhaps, but it would take a multi-zillion dollar study.

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Pain management is only taught in 3% of medical schools. It loses money. Procedures make money. This is not about procedures. It’s about thinking and using proven mechanisms. Ask any MD and they’ve never heard of glial modulators. We all rely instead  on Pharma and medications approved by FDA to educate on all treatment – that goes for NIH and all medical schools and hospitals too. They teach opioids plus 1960’s pain management. When CDC takes away the opioids, we are treating pain using 1960’s methods plus gabapentin, Lyrica, Cymbalta. And what % of patients did these new drugs help?  one third? Half? No wonder 50 million people have chronic pain. We have 5 different short acting fentanyl products alone. And why is Amazon selling fentanyl when every city and country in the U.S. has people dying from it. Horse and dog fentanyl is same as human fentanyl. Some people think ketamine is a horse tranquilizer, as if it’s shocking to them to think horses and humans would respond differently. Give enough of a sedative, you go into a coma and then you can die. Use medication only under medical supervision.

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