NebKet (Nebulized Ketamine)

 

Why NebKet?

Delivery of Ketamine via a Nebulizer with a mask provides good control of Ketamine blood level. Absorption through the lungs is rapid and consistent. This obviates the need for an IV permitting self-administration. Self-administration promises to dramatically reduce the cost of this therapy. This could be a truly cost saving and useful adjunct for helping what may be several million patients in the USA alone. Hopefully this technique will be adopted in clinics and that they will begin to collect the needed data to determine the optimal concentration, frequency etc. NebKet will facilitate greater access of Nebulized Ketamine for the patients, many of whom are not being given much in the way of follow up care (e.g. boosters) because of cost and distance barriers.  If they could be trained to self-manage the way diabetics, hypertensives and so many others do, it will do a great deal of good. Nasal is an attempt to solve the "lack of access" and "cost" problem. Nebulizer may be a better solution.

 

The advantages of NebKet is simply that an IV is avoided. There is a great deal of high skilled labor (read expense) involved in IV placement. Although untold millions of IV's are started on patients quite safely each year, it's clear that sticking a needle into a patient always involves some risk of untoward events. No one starts an IV for treating asthma, except in the worst exacerbation.

 

Asthma nebulizers are simple, inexpensive devices used by asthma patients for decades to self-administer bronchodilators.  The injectable form of Ketamine dispensed by hospitals works just fine in a nebulizer, converting it into a potent mist.  Imagine if Asthma patients had to go to a clinic for an IV infusion, every time their asthma acted up.  For that matter, there are many other classes of patients who can be quickly trained to monitor their glucose, administer insulin, do special exercises, change their own dressings etc. Ketamine can easily be adapted to this approach by treating patients in clinics, training them to load the drug into the nebulizer and self-administering on perhaps a once-per-month basis.

Dr Stanton's article on Nebulized Ketamine>

Is NebKet safe?

Although the drug has no known lethal dose, overdose is still a bad event as it can cause possibly nightmarish hallucinations, where a patient could potentially harm themselves or others. A patient could possibly become incontinent as well - not a desirable outcome. To avoid this, blood level of Ketamine should be tightly controlled. Delivery of Ketamine via a Nebulizer with a mask provides good control of Ketamine blood level. Absorption through the lungs is rapid and consistent.

The procedure has a huge safety margin compared to other methods, including IV infusion.  All other methods can lead to a scenario in which the entire dose is delivered at once, a highly undesirable outcome even if rare.

There is a high safety window as the Nebulizer can be switched off or the mask removed by the patient. It is important to use a free standing Nebulizer with the mask, not a hand-held variety.

The reason Anesthesiologists and Emergency Physicians love this drug is that the drug has minimal effect on the patient’s breathing or blood pressure. This is particularly true of the sickest, riskiest patients e.g. trauma victims and women hemorrhaging while delivering their babies. It is because of this huge safety factor that Ketamine is used as an intramuscular dart to sedate wild animals like lions and tigers, since the animal goes into a trance like state with little danger to its overall health.

 

Is the effect of NebKet similar to Intranasal?

Patients who have the prescription for intranasal, after trying the nebulizer, noted that the experience is much more like the IV.  It may not be the exact equivalent, but it brings with it such important advantages that NebKet method can be quite useful, maybe even a game changer.

 

Is more Ketamine used in the NebKet technique?

The nebulizer technique is quite wasteful of the drug compared to the IV technique, using about 5 times as much Ketamine. This is because much of the vapor is expelled to the room and thus not inhaled.

Use the standard 50mg/ml concentration that is always used in anesthesia practice. It is possible that some large patients may require a higher concentration (which can be prepared in compounding pharmacies).  It is also possible that some smaller patients might require dilution.  However, there seems to be a wide window of safety and none of the patients were in danger of dissociating (loosing contact, completely anesthetized).  All report substantial benefit.

Though the amount of drug used is 5x, the dose actually delivered is about equivalent to the IV technique, just judging by the observed effects and patient testimony.  Someone (with money) would have to do a proper study to compare actual blood levels to know for sure.

 

Does NebKet provide a controlled rate of Ketamine administration?

Ketamine is remarkably safe. There is no known lethal dose. However, blood levels of Ketamine should be tightly controlled because overdose can cause a patient to temporarily lose contact with reality and possibly experience hallucinations. This is why a computer-controlled IV pump is considered the gold standard. However Nebulization provides a remarkably consistent and predictable administration rate, while avoiding the disadvantages of the IV technique.

 

How to control the rate of NebKet administration?

There is less precise control over the delivery in mg/min with the nebulizer, but the differences may not be important. Delivery of Ketamine via a Nebulizer with a mask provides good control of Ketamine blood level. Since absorption through the lungs is rapid and consistent, nebulization provides a remarkably consistent and predictable administration rate.

Even with the IV, when the exact amount of Ketamine at the exact rate is delivered, patients may feel different every time. It is obvious that there are more factors involved in the Ketamine therapy.

 

How does self-administering of NebKet go?

STEP-BY-STEP INSTRUCTIONS

The nebulizer can only hold about a 50-60 min quantity (about 10mls),  so the session is automatically ended when the drug runs out.  Also patients can simply pull the mask off or turn the switch off on the device to limit further absorption if need be.  In order to get the liquid out the glass ampule, patients will also require a 10ml syringe and either a needle or even better, a needleless cannula that prevents the user from accidentally sticking themselves.

Try to breath by mouth and avoiding nasal breathing as much as possible as Ketamine can be absorbed into the nasal mucosa and then slowly absorbed, lengthening the recovery time after a treatment. The nebulizer can only hold about a 50-60 min quantity (about 10mls), so the session is automatically ended when the drug runs out. Also, patients can simply pull the mask off or turn the switch off on the device to limit further absorption if need be. In order to get the liquid out the glass ampule, patients will also require a 10ml syringe and either a needle or even better, a needleless cannula that prevents the user from accidentally sticking themselves.

Ketamine wears off fairly quickly after a session. It is strongly recommended emptying your bladder just prior to a session as Ketamine seems to make people want to pee, and you should plan on sitting in your chair and NOT WALKING for at least a half an hour after a completed session.  Ketamine causes profound ataxia resembling alcohol intoxication and can cause you to slur your speech and stumble like a drunk. Patients should absolutely not drive or operate machinery for 3-4 hrs after a session.

The onset of effect is slightly slower than IV (perhaps 4-5 mins). The recovery period is longer, about 10-20 mins longer. Patients will ‘taste’ the ketamine which does not occur with IV (an slightly unpleasant medicine like flavor hard to describe) and little droplets can form on your nose, so you may want to have a hanky handy. Ideally patients would be best off to have a friend or family member present to observe and assist. Patients should absolutely not drive or operate machinery for at least 5 hrs after a session. 

 

Does the Nebket experience feel different from the IV experience?

No, but it is close and the differences may not be important.  We will only know the answer to this question once large scale studies are conducted, which may be quite some time.  There is less precise control over the delivery in mg/min with the nebulizer.  Based on clinical observations and patient testimony, the effects appear very similar with the following differences:
1. Slightly longer onset (~5mins longer with the nebulizer)
2. Slightly longer recovery time (~10-20mins)
3. Patients can 'taste' the Ketamine with the Nebulizer (similar to intranasal) which some patients describe as mildly unpleasant.
Of course, nebulizer offers significant advantages (No IV, possibility of self-administration, more patient control over the intake of the drug, lower cost).

Ketamine veterans with a history of many infusions (and currently using Nasal Ketamine) and also Ketamine first-timers reported high satisfaction with the approach and the veterans felt that it closely mimicked the IV experience.  Some Ketamine veterans seemed to feel that NebKet is actually superior in its effects, not even counting the fact that they avoided an IV. All patients seemed to be very excited about the results.

 

How do I know that I get the greatest therapeutic benefit?

Based on observations and conversations with the patients, the greatest therapeutic benefit comes when the patients attain what can be called "the sweet spot." This is a blood level where the patient has an intense experience, i.e. they are slurring their speech, quite ataxic and many experience strong emotions, some sobbing at times. The key is to make certain that they do not get a blood level sufficient to induce 'dissociation' at which point they are completely anesthetized, unaware of their surroundings and unable to respond to command.

There is a fairly forgiving window between the 2 blood levels and the patients were not in danger of dissociating with this technique. The patients themselves actually have a very good sense of whether they are losing control, and found it quite comforting to know that they could simply pull the mask off their face at any time.

After the ketamine sessions some patients report that they "feel philosophical", that they go through the memories or current events which they've been suppressing to think about.

 

So what is the advantage NebKet over IV?

1) NebKet is a safer procedure- IV administration comes with its own list of risks and complications.  These include infection, hematoma, that is, continued bleeding from the vein under the skin after either ‘spearing’ the vein through when attempting to place the IV or later after removing a properly placed catheter from a vein that continues bleeding. IV’s can be inadvertently disconnected with subsequent blood loss, infiltration can occur (where medicine is infused into the subcutaneous tissue instead of into the vein), and more rarely blood clots, nerve damage and thrombophlebitis.

2) Fear of needles- Some patients are positively terrified of needles. Causing massive anxiety just prior to giving Ketamine is not a great idea since the drug is a hallucinogen and tends to ‘magnify’ the emotional state of the patient.

3) Veins are precious- There is a growing awareness in the medical profession that ‘veins are precious’. Huge numbers of patients are presenting in hospitals who have had multiple hospital admissions and thus multiple vein sticks, whose peripheral veins are now extremely fragile and limited. Any technique that can preserve the veins in these patients is highly valuable. This goes double for any patient with a history of IV drug abuse.

4) Patients are more comfortable when they have more control over the procedure- There is a therapeutic window where the patient experiences an intense effect from the Ketamine without crossing into dissociation that seems to produce the most benefit. The patients themselves have a very good sense of whether they are losing control, and found it quite comforting to know that they could simply pull the mask off their face at any time.

5) A cost saver for the patients- Self-administration promises to dramatically reduce the cost of this therapy.

6) Income stream for physicians- If some intrepid Physicians, CRNA’s, APRN’s or PA’s out there with prescribing power start writing these prescriptions, they might find it to be a very nice supplementary income stream. E.g., charge $50/visit for checkups and renewals without any of the expense and heartaches associated with filing with insurance companies, and avoid the risks, time and expense of IV infusions. Collect 1000 patients and bingo, nice income stream. Initial sessions should be conducted under the auspices of the clinic setting, with patients self-administering in their homes after that. There could be a setup where patients are only dispensed only 1 or 2 treatments/month and not the ad libitum situation as with Nasal. There is also a possibility for a nurse to administer NebKet at a patient's home.

7) Ease of administration- The expense of IV supplies versus nebulization is comparable. But consider also how easy it is to administer NebKet.

8) Using self-administration patients don't need to take a day or even a week from work to travel to the nearest Ketamine Clinic.

 

Is self-administering of Nebulized ketamine safe?

Some patients have said their doctors refused to prescribe because the side-effects are unknown. This argument is just silly. There is no known lethal dose of Ketamine. Contrast that with drugs like narcotics or insulin which can easily kill a patient if the drug is either abused or a miscalculation is made.

Of course patients should be initially treated in the clinic setting and trained to use the equipment properly, like asthmatics, diabetics, etc. For self-administration, obtain a stand-alone nebulizer unit. Stand alone meaning not hand-held. Instead, the device sits on a table top with some plastic tubing leading to the nebulizer chamber, which is attached to a plastic mask that you place over your face and fix in place with a bit of elastic.

Ketamine is highly sedating and you cannot be expected to hold anything up to your face for the whole session. Safety wise, if you feel that the strength is a bit too much for you, you can simply pull the mask off your face or press the off switch on the device. Even if the patient is somehow unable to do those things, the session will automatically end in ~50mins when the medicine runs out.

 

Is there a risk of addiction to Ketamine self-administered via Nebulizer?

NebKet holds out the possibility of patients self-administering in their homes.  It is hard to say whether this is a viable practice or not, but it would certainly be a cost saver for the patients. To avoid addiction in this scenario, as it is happening with the Nasal Ketamine, there could be a setup where patients are only dispensed only 1 or 2 treatments/month and not the ad libitum situation as with Nasal.  Of course, addiction with Ketamine seems rare compared to Benzodiazapines, Narcotics and Alcohol, with no real known withdrawal symptoms and a zero mortality due to overdose.

 

What is the cost for Nebulized ketamine?

The drug itself is cheap at about $6 per vial.

Cost to a patient for a nebulized self-administered ketamine:

- around $100 for a nebulizer and a mask

- $6 for Ketamine per session

- cost for the first visits at a physician's office or clinic

- cost for periodic check-ups and prescription renewal

For physicians-

Self-administration by nebulizer of Ketamine is not going to be a big money maker for any drug company or for the average doctor. However, if some intrepid Physicians, CRNA’s, APRN’s or PA’s out there with prescribing power start writing these prescriptions, they might find it to be a very nice supplementary income stream. E.g., charge $50/visit for checkups and renewals without any of the expense and heartaches associated with filing with insurance companies, and avoid the risks, time and expense of IV infusions. Collect 1000 patients and bingo, nice income stream. Initial sessions should be conducted under the auspices of the clinic setting, with patients self-administering in their homes after that. There is also a possibility for a nurse to administer NebKet at a patient's home.

 

What Nebulizer to use?

A nebulizer from justnebulizers.com called the Pari Vios (~$60) can be used. Its the old air compressor type, so its a bit noisy, but it holds 10mls and provides about a 50 minute session.

There's also a newer (vibrating mesh) unit available, $160, which is supposedly silent, but holds only 7mls. If you consider noise an issue, try this one.

 

What are the barriers for adopting Nebulized Ketamine by physicians?

Although there is an opportunity to lower patient costs with home self-administration, this would be a sore point with practitioners. It needn't be. Price for a NebKet administration in office can be the same as for the IV. Patients could be trained to self-administer, but keep returning to the office for checkups, prescription renewals, or perhaps the office could even control the dispensing, giving out only a few vials as deemed appropriate. There is also a possibility for a nurse to administer NebKet at a patient's home. There is an opportunity to make up on volume what might be lost by having fewer in office sessions.

Of course, there will be a chorus of voices cautioning of the dangers of sending patients home with a dangerous, addictive poorly understood drug. However these voices are on shaky ground in a world where alcohol and powerful narcotics are legal and people are dying in the 10's of thousands. As Woody Allen once said, "intellectuals are like the mafia, they only kill their own".

 

Why medical professionals might be reluctant to permit home administration of NebKet?

Medical professionals who can obtain and prescribe Ketamine are often reluctant to offer it for home use due to several factors:

 

1) They fear it might reduce their revenue stream. However, revenue might actually be enhanced by a lower cost, higher volume business model. 

 

2) Prescribers may fear misuse or abuse, regulatory scrutiny or increased liability. However, the drug has a wide window of safety, Nebket offers much higher delivery precision vs nasal, and compared to prescribing Insulin, Narcotics, sleeping pills and several other drug/device categories, liability issues do not seem to be a credible problem. Misuse and abuse is a real risk, but miniscule compared to Benzodiazipines, Narcotics and other categories.

 

Medical professionals who prescribe Ketamine to a patient, can have several first treatments in their office in order to observe a patient and then prescribe only one dose/visit. This way they will be sure that Ketamine is not being abused. However, the dosages used for the treatment of depression are minuscule compared to what interests abusers.

 

4)Prescribers may hesitate to offer a therapy they were not formally taught in their training. However, there are numerous examples of techniques and procedures that physicians acquire through self teaching. Currently there are no formal training classes offered either for Nebket or for the traditional IV administration of Ketamine.

 

 

How can I find a NebKet provider?

Currently, there are only a few NebKet providers available.

1. Call Ketamine providers in your area and talk to the medical professional who is in charge of Ketamine administration, not to a receptionist, about NebKet.

2. You may be able to find Psychiatrists, or Nurse Practitioners, or family practice doctors who have their own practice (not working for a hospital) and who will be able to prescribe you Ketamine for your nebulizer after several procedures in their office in order to evaluate your reaction to Ketamine. Or they may be willing to perform NebKet procedure at their office at a lower cost. Simply call them and send them the links for NebKet technique.

3. If Ketamine providers use only IV method, kindly ask what is their solution for the patients with fear of needles or who have poor venous access. Causing massive anxiety just prior to giving Ketamine is not a great idea since the drug is a hallucinogen and tends to ‘magnify’ the emotional state of the patient. The few remaining veins in people with poor venous access should not be wasted when there is a simple alternative. NebKet is a great solution for such patients.

 

end faq