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Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

This Rhythm is Hilarious

Fri, 04 Jan 2019 12:46:23 -0500 by
 


Click on the image to make it larger.
 

Apparently, the second 12 lead was after 150 mg of amiodarone. The hilarity is the amiodarone.

I received this in an email. It is reported to have been posted on Facebook, but I choose not to have access to Facebook, so I do not have any more details. I am occasionally tempted to set up an account again, but I generally prefer intentional comedy.

Everything you need to know is in the first 12 lead.

Things that do not matter:

Distance to the hospital.

Time of onset.

Last meal.

National Registry certification.

Et cetera.

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Filed Under: ACLS, Assessment, Cardiology, Critical Judgment, Heresy, Pharmacology, Placebo, Understanding, V Tach

The Grinch Who Stole Reality

Fri, 28 Dec 2018 13:00:46 -0500 by
 

And the Grinch, with his Grinch-feet ice cold in the snow, stood puzzling and puzzling, how could it be so?

It came without ribbons epi.

It came without tags amio.

It came without packages oxygen, boxes tubes or bags.

And he puzzled and puzzled ’till his puzzler was sore. Then the Grinch thought of something he hadn’t before.

Maybe Christmas living, he thought…doesn’t come from a store drug.

Maybe Christmas living, perhaps…means a little bit more!

 

With apologies to Dr. Seuss (Theodore Geisel) for the modification of his parable.

There are important differences between the minimal criteria for life and the criteria for a meaningful life. Many of us don’t like to think about that, because many of us don’t like thinking. Thinking can be hard. Making excuses for not thinking – priceless (at least, as long as you don’t think about it).

We have been focusing on the least honest way of reporting outcomes – a pulse – Oooh!, or maybe even 30 days of a pulse – Oood-Ahhh! After all, reality does not support continuing to do what we have been doing. If we admit that we have been causing harm, then we may have to take responsibility for our actions.

We do not want to take responsibility for our actions. We were only following orders.

Doctors, PAs (Physician Assistants), NPs (Nurse Practitioners), nurses, paramedics, EMTs, techs, . . . do not want to take responsibility for what we get paid for. Accountability is for people who think – not for us.

We have blamed science/evidence for requiring that we confront reality. As explained by Dr. Seuss, we want simple answers that do not require understanding. Give us algorithms to mindlessly follow. Give us mnemonics.

We have been giving epinephrine (adrenaline in Commonwealth countries) for over half a century with no evidence of safety or improvement in the outcome that matters most.

Why?

We haven’t wanted to know.

The first study to look at the effect of placebo vs. epinephrine on neurological survival was cut short – with only a tiny fraction of what would be needed to produce any kind of statistically useful information, except for some of the true believers, who made the same kinds of mistakes that have been made for other discarded treatments – treatments discarded due to failure to work, discarded due to harm, or discarded due to both.

Don’t study this. Just believe. Belief makes us feel good. Attack science for encouraging understanding.
 

This study was designed as a multicentre trial involving five ambulance services in Australia and New Zealand and was accordingly powered to detect clinically important treatment effects. Despite having obtained approvals for the study from Institutional Ethics Committees, Crown Law and Guardianship Boards, the concerns of being involved in a trial in which the unproven “standard of care” was being withheld prevented four of the five ambulance services from participating.[1]

 

In addition adverse press reports questioning the ethics of conducting this trial, which subsequently led to the involvement of politicians, further heightened these concerns. Despite the clearly demonstrated existence of clinical equipoise for adrenaline in cardiac arrest it remained impossible to change the decision not to participate.[1]

 

What was the conclusion produced by the Jacobs study?
 

CONCLUSION: Patients receiving adrenaline during cardiac arrest had no statistically significant improvement in the primary outcome of survival to hospital discharge although there was a significantly improved likelihood of achieving ROSC.[1]

 

As the homeopaths put their spin on studies that do not really support their claims, people who do not understand science put similar spin on the results of this. For example, if you take a Bayesian approach[2], but distort it to mean that you give extra weight to everything that supports your belief and take away credit from everything else, you can claim that this is an example of science proving that epinephrine works.

Another way of doing this is to claim that you don’t give the 1 mg dose of epinephrine, therefore the study does not apply to your patients. After all, you are just engaging in a poorly documented, unapproved study, which allows you to think of the survivors as examples of the drug working and make excuses for the rest. Of course, if you don’t give the 1 mg dose of epinephrine, is there any evidence that your treatment is safe or effective? No.

Rather than insisting that this method of dosing patients be studied, in order to determine if it really is safe or if it really is effective at anything other than getting a pulse in a brain-dead body, claim to be ahead of the science.

Why find out what is really best for the patients, when there are so many ways of declaring victory and running away?

In 2018, we had the results of the next study of placebo vs. adrenaline (epinephrine in non-Commonwealth countries, but only Commonwealth countries have bothered to do the research). The conclusion was the same as the conclusion for the only previous study.
 

CONCLUSIONS: In adults with out-of-hospital cardiac arrest, the use of epinephrine resulted in a significantly higher rate of 30-day survival than the use of placebo, but there was no significant between-group difference in the rate of a favorable neurologic outcome because more survivors had severe neurologic impairment in the epinephrine group.[3]

 

Has anyone else stated that the use of epinephrine should be limited to controlled trials?

Not that I know of.

Everyone else seems to be claiming that giving smaller boluses of epinephrine. or giving titrated infusions of epinephrine is different. Some claim that it is nihilism to refuse to believe in their slightly different treatment – at least until there is undeniable evidence of lack of benefit, or undeniable evidence of harm, or both.

Requiring evidence of benefit, before using a treatment on a patient is being reasonable.

Using inadequately studied treatments on people when they are at their most vulnerable is not good medicine.

A doctor’s oath to Apollo does not include a requirement to perpetuate dogma, but medicine is only slowly starting to focus on what is best for patients, rather than what is best for appearances.

Dr. Ryan Jacobsen addressed a similar dogma, when he got rid of the long spine board in the system where he was medical director. His description of the evidence applies to epinephrine (bolus, mini-bolus, infusion, patch, inhaler, down the tube, oral, whatever) –

Other than historical dogma and institutional EMS medical culture we can find no evidence-based reason to continue to use the Long Spine board epinephrine as it currently exists in practice today.[4]

I changed EMS to medical and the Long Spine board to epinephrine.

We have good evidence that if your loved one is a laboratory pig, rat, dog, . . . we can kill them and get them back neurologically intact with epinephrine – and with other treatments that have been discarded because they do not have the same effect on humans as on lab animals.

Let us treat your loved ones like the lab animals we think they are.

Don’t use EBM (Evidence-Based Medicine), because belief is more important than reality.

The world is a comedy to those that think; a tragedy to those that feel. – Horace Walpole.

Keep thinking. Keep demanding evidence. After the nonsense being preached by the believers is exposed, we can improve the outcomes for our patients, because medicine is about doing what is best for the patient, and not about protecting the dogma.

–

Footnotes:

–

[1] Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial
Jacobs IG, Finn JC, Jelinek GA, Oxer HF, Thompson PL.
Resuscitation. 2011 Sep;82(9):1138-43. doi: 10.1016/j.resuscitation.2011.06.029. Epub 2011 Jul 2.
PMID: 21745533

Free Full Text PDF Download from semanticscholar.org

–

[2] Bayesian inference
Wikipedia
Article

–

[3] A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest.
Perkins GD, Ji C, Deakin CD, Quinn T, Nolan JP, Scomparin C, Regan S, Long J, Slowther A, Pocock H, Black JJM, Moore F, Fothergill RT, Rees N, O’Shea L, Docherty M, Gunson I, Han K, Charlton K, Finn J, Petrou S, Stallard N, Gates S, Lall R; PARAMEDIC2 Collaborators.
N Engl J Med. 2018 Aug 23;379(8):711-721. doi: 10.1056/NEJMoa1806842. Epub 2018 Jul 18.
PMID: 30021076

–

[4] Johnson County EMS System Spinal Restriction Protocol 2014
Ryan C. Jacobsen MD, EMT-P, Johnson County EMS System Medical Director
Jacob Ruthsrom MD, Deputy EMS Medical Director
Theodore Barnett MD, Chair, Johnson County Medical Society EMS Physicians Committee
Johnson County EMS System Spinal Restriction Protocol 2014 in PDF format.

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Filed Under: 'Alternative' Medicine, ACLS, Cardiac Arrest, Critical Judgment, EBM, Epinephrine, Ethics, Evidence, Heresy, Pharmacology, Research, Science

Anti-Vaccine Means Pro-Corruption

Fri, 30 Nov 2018 09:30:45 -0500 by
 

Can you be opposed to vaccines and not be supporting corruption? What does it mean to oppose vaccines?

Vaccines are probably the safest and most effective medical intervention available. Anti-vaxers oppose that.

Vaccines save millions of lives every year. Anti-vaxers oppose that.

If you disagree, provide valid evidence that anything else is as safe as vaccines and provide valid evidence that anything else is as effective as vaccines. There is the small possibility that I am wrong and that vaccines are only second, or maybe even third, among the safest and most effective medical interventions available.

But aren’t the anti-vaxers trying to protect children from unnecessary risk?

That is one of many anti-vaccine claims, but it is just another anti-vax lie.

Look at these heroes of the anti-vaccine propaganda industry. Mark and David Geier.

David Geier pretends to be a doctor, even though he never has been a doctor, or even been enrolled in a medical school.
 

As explained above, the Board concludes that David Geier practiced medicine in Maryland without being licensed by the Board to practice in violation of section 14-601 of the Health Occupations Article.[1]

 

Mark Geier did become a doctor, but the corruption of the anti-vax propaganda and treatment business led him to violate his responsibility to protect his patients. If you see Mark Geier working as a doctor, call the police.
 

Since 2011, Geier’s medical license has been suspended or revoked in every state in which he was licensed over concerns about his autism treatments and his misrepresentation of his credentials to the Maryland Board of Health, where he falsely claimed to be a board-certified geneticist and epidemiologist.[4] [2]

 

What is so bad about the Geiers and why do anti-vaxers continue to worship the Geiers?

Mark and David Geier castrate children with a chemical that has been approved for some medical uses, but definitely not to treat autism. The chemical has never been shown to be safe or even slightly effective for that purpose. If you think that autism is the worst thing ever – worse than smallpox, measles, polio, pertussis, et cetera, you may think that it is morally acceptable to torture children and to have faith in these quacks.
 


 

The fake doctor (David) is on the left and the revoked license doctor (Mark) is on the right.

But isn’t it an exaggeration to call this chemical castration.
 

Speaking about one teen he put on the drug, Mark Geier said: “I wasn’t worried about whether he would have children when he is 25 years old. If you want to call it a nasty name, call it chemical castration. If you want to call it something nice, say you are lowering testosterone.”[3]

 

For those who claim that this would be a short-term treatment, and the side effects would be minimized, that’s not the way quacks work – especially with paying customers. These are not reasonable people. Quacks will be expected to keep giving the magic treatment, possibly increasing the dose several times, until that treatment works, because they think that they know believe that it works. Reasonable people would be expected to stop never start this unapproved and dangerous treatment to begin with. Since the treatment does not work, and is expected to make the patients’ conditions worse, these people would not be expected to stop. As with other alternative medicine, treatment failures are blamed on the patient, or on the family. Quacks do not take responsibility for the incompetence of using chemicals that are dangerous and ineffective.

But what if it really does work?

Almost every proposed treatment, regardless of what it is, will be found to be more harmful than beneficial. Most are discarded long before they get to the point of being tested on actual humans. Poisoning patients, based on What if it works? is dangerous, unethical, and irresponsible.

If you have an autistic child, do not let the Geiers chemically castrate your child for fun and profit.

How do the same anti-vaxers, who claim that they are protecting their children from what is probably the safest and most effective medical intervention available, support this dangerous, unethical, and irresponsible treatment?

That is the way anti-vaxers think. Anti-vccine claims are arrogant rejections of competence, science, and reality. Protect your children from anti-vaxers.

–

Footnotes:

–

[1] In the matter of David A. Geier before the Maryland State Board of Physicians
Case Nos. 2008-0022 & 2009-0318
Maryland Department of Health
Final Decision and Order in PDF format.

–

[2] Mark Geier
Wikipedia
Article

–

[3] ‘Miracle drug’ called junk science
Trine Tsouderos
Tribune reporter
May 21, 2009
Article

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Filed Under: Anti-Science, Children, Conspiracy Theories, Corruption, Critical Judgment, Denialism, Evidence, Pharmacology, Research, Risk Management

A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest – Part I

Thu, 19 Jul 2018 14:40:46 -0400 by
 
Also to be posted on ResearchBlogging.org when they relaunch the site.

The results are in from the only completed Adrenaline (Epinephrine in non-Commonwealth countries) vs. Placebo for Cardiac Arrest study.
 


 

Even I overestimated the possibility of benefit of epinephrine.

I had hoped that there would be some evidence to help identify patients who might benefit from epinephrine, but that is not the case.

PARAMEDIC2 (Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration in Cardiac Arrest) compared adrenaline (epinephrine) with placebo in a “randomized, double-blind trial involving 8014 patients with out-of-hospital cardiac arrest”.

More people survived for at least 30 days with epinephrine, which is entirely expected. There has not been any controversy about whether giving epinephrine produces pulses more often than not giving epinephrine. As with amiodarone (Nexterone and Pacerone), the question has been whether we are just filling the ICUs and nursing home beds with comatose patients.
 

There was no statistical evidence of a modification in treatment effect by such factors as the patient’s age, whether the cardiac arrest was witnessed, whether CPR was performed by a bystander, initial cardiac rhythm, or response time or time to trial-agent administration (Fig. S7 in the Supplementary Appendix). [1]

 

The secondary outcome is what everyone has been much more interested in – what are the neurological outcomes with adrenaline vs. without adrenaline?

The best outcome was no detectable neurological impairment.
 

the benefits of epinephrine that were identified in our trial are small, since they would result in 1 extra survivor for every 112 patients treated. This number is less than the minimal clinically important difference that has been defined in previous studies.29,30 Among the survivors, almost twice the number in the epinephrine group as in the placebo group had severe neurologic impairment.

Our work with patients and the public before starting the trial (as summarized in the Supplementary Appendix) identified survival with a favorable neurologic outcome to be a higher priority than survival alone. [1]

 


Click on the image to make it larger.
 

Are there some patients who will do better with epinephrine than without?

Maybe (I would have written probably, before these results), but we still do not know how to identify those patients.

Is titrating tiny amounts of epinephrine, to observe for response, reasonable? What response would we be looking for? Wat do we do if we observe that response? We have been using epinephrine for over half a century and we still don’t know when to use it, how much to use, or how to identify the patients who might benefit.

I will write more about these results later

We now have evidence that, as with amiodarone, we should only be using epinephrine as part of well controlled trials.

–

Also see –

How Bad is Epinephrine (Adrenaline) for Cardiac Arrest, According to the PARAMEDIC2 Study?

–

Footnotes:

–

[1] A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest.
Perkins GD, Ji C, Deakin CD, Quinn T, Nolan JP, Scomparin C, Regan S, Long J, Slowther A, Pocock H, Black JJM, Moore F, Fothergill RT, Rees N, O’Shea L, Docherty M, Gunson I, Han K, Charlton K, Finn J, Petrou S, Stallard N, Gates S, Lall R; PARAMEDIC2 Collaborators.
N Engl J Med. 2018 Jul 18. doi: 10.1056/NEJMoa1806842. [Epub ahead of print]
PMID: 30021076

Free Full Text from NEJM

All supplementary material is also available at the end of the article at the NEJM site in PDF format –

Protocol

Supplementary Appendix

Disclosure Forms

There is also an editorial, which I have not yet read, by Clifton W. Callaway, M.D., Ph.D., and Michael W. Donnino, M.D. –

Testing Epinephrine for Out-of-Hospital Cardiac Arrest.
Callaway CW, Donnino MW.
N Engl J Med. 2018 Jul 18. doi: 10.1056/NEJMe1808255. [Epub ahead of print] No abstract available.
PMID: 30021078

Free Full Text from NEJM

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Filed Under: 2018 ACLS Guidelines, ACLS, Common Sense, Critical Judgment, Drug Shortages, Epinephrine, Ethics, Evidence, Heresy, Intubation, Lasix, Mythology, Narrative Fallacy, Oxygen, Pharmacology, Placebo, Potentially Reversible Causes, Probability, Research, Research Blogging, Resuscitation Theater, tPA

Cardiac arrest victim Trudy Jones ‘given placebo’ – rather than experimental epinephrine

Mon, 26 Mar 2018 08:20:13 -0400 by
 

As part of a study to find out if epinephrine (adrenaline in Commonwealth countries) is safe to use in cardiac arrest, a patient was treated with a placebo, rather than the inadequately tested drug. Some people are upset that the patient did not receive the drug they know nothing about.[1]

The critics are trying to make sure that we never learn.

We need to find out how much harm epinephrine causes, rather than make assumptions based on prejudices.

When used in cardiac arrest, does epinephrine produce a pulse more often?

Yes.

When used in cardiac arrest, does epinephrine produce a good outcome more often?

We don’t know.

In over half a century of use in cardiac arrest, we have not bothered to find out.
 


 

We did try to find out one time, but the media and politicians stopped it.[2]

We would rather harm patients with unreasonable hope, than find out how much harm we are causing to patients.

We would rather continue to be part of a huge, uncontrolled, unapproved, undeclared, undocumented, unethical experiment, than find out what works.

Have we given informed consent to that kind of experimentation?

Ignorance is bliss.

The good news is that the enrollment of patients has finished, so the media and politicians will not be able to prevent us from learning the little that we will be able to learn from this research.[3]

Will the results tell us which patients are harmed by epinephrine?

Probably not – that will require a willingness to admit the limits of what we learn and more research.

What EMS treatments have been demonstrated to improve outcomes from cardiac arrest?

1. High quality chest compressions.
2. Defibrillation, when indicated.

Nothing else.

All other treatments, when tested, have failed to be better than nothing (placebo).

–

Footnotes:

–

[1] Cardiac arrest victim Trudy Jones ‘given placebo’
BBC News
23 March 2018
Article

–

[2] Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial
Jacobs IG, Finn JC, Jelinek GA, Oxer HF, Thompson PL.
Resuscitation. 2011 Sep;82(9):1138-43. Epub 2011 Jul 2.
PMID: 21745533 [PubMed – in process]

Free Full Text PDF Download from semanticscholar.org
 

This study was designed as a multicentre trial involving five ambulance services in Australia and New Zealand and was accordingly powered to detect clinically important treatment effects. Despite having obtained approvals for the study from Institutional Ethics Committees, Crown Law and Guardianship Boards, the concerns of being involved in a trial in which the unproven “standard of care” was being withheld prevented four of the five ambulance services from participating.

 

In addition adverse press reports questioning the ethics of conducting this trial, which subsequently led to the involvement of politicians, further heightened these concerns. Despite the clearly demonstrated existence of clinical equipoise for adrenaline in cardiac arrest it remained impossible to change the decision not to participate.

 

–

[3] Paramedic2 – The Adrenaline Trial
Warwick Medical School
Trial Updates
 

Trial Update – 19 February 2018:
PARAMEDIC2 has finished recruitment and we are therefore no longer issuing ‘No Study’ bracelets. The data collected from the trial is in the process of being analysed and we expect to publish the results in 2018. Once the results have been published, a summary will be provided on the trial website.

 

–

Edited 12-27-2018 to correct link to pdf of Jacobs study in footnote 2.

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Filed Under: 'Alternative' Medicine, ACLS, Cardiac Arrest, Cardiology, Correction, CPR, Critical Judgment, Ethics, Evidence, Journalism, Pharmacology, Placebo, Research, Risk Management, Science

Drug Shortages Affecting EMS

Mon, 31 Jul 2017 23:59:20 -0400 by

 

The most recent FDA (Food and Drug Administration) listing of drug shortages, editing out the many cancer drugs, and other non-EMS drugs, includes the following:
 

Generic Name or Active Ingredient                                                 Status
 

Albuterol Sulfate Inhalation Solution (0.5%)         Resolved

This is important, but one way of dealing with a nebulized albuterol shortage is to alternate albuterol with nebulized saline. this prevents giving too much albuterol to the patient who is maintaining a reasonable oxygen saturation and keeping the airway humidified.
 

Atropine Sulfate Injection         Currently in Shortage

We should be accumulating atropine, since we no longer use atropine for asystole. Atropine maintains its strength, even when stored for extended periods, so we should only discard atropine when there is contamination.
 

Calcium Chloride Injection, USP         Currently in Shortage

Calcium (chloride or gluconate) appears to be the best drug for hyperkalemia. We are fortunate in EMS to not have to deal with sodium polystyrene (Kayexalate), which is just a means of creating the appearance of clostridium difficlie. Senna glycoside (ex-lax) can be just as effective at causing diarrhea and anything that causes diarrhea will cause some removal of potassium.
 

Calcium Gluconate Injection         Currently in Shortage

See above.
 

Cromolyn Sodium Inhalation Solution, USP         Currently in Shortage
 

Dexamethasone Sodium Phosphate Injection         Resolved
 

Dextrose 50% Injection         Currently in Shortage

We should be using 10% dextrose, rather than 50%, but we are slow to learn from our mistakes.

Comment on 10% Dextrose vs 50% Dextrose.
 

Epinephrine Injection, 0.1 mg/mL         Currently in Shortage

Maybe we will be using less epinephrine after the results of the Paramedic2 trial are published. I expect that some patients will be shown to benefit from epinephrine in cardiac arrest. I hope that the results will help us to identify which patients benefit from epinephrine in cardiac arrest and which patients have worse outcomes because of receiving epinephrine in cardiac arrest. I don’t really expect these answers, because we seem to be trying to avoid asking appropriate questions about drug treatment.
 

Epinephrine Injection, 1 mg/mL         Resolved
 

Fentanyl Citrate (Sublimaze) Injection         Currently in Shortage

There are other drugs that are effective for pain management. Hydromorphone (Dilaudid) can be used safely by EMS.
 

Labetalol Hydrochloride Injection         Currently in Shortage
 

Lidocaine Hydrochloride (Xylocaine) Injection         Currently in Shortage

EMS should have disposed of our supplies of lidocaine and amiodarone following the ALPS and PROCAMIO.

Dr. Kudenchuk is Misrepresenting ALPS as ‘Significant’

The PROCAMIO Trial – IV Procainamide vs IV Amiodarone for the Acute Treatment of Stable Wide Complex Tachycardia
 

Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine         Currently in Shortage

This is more for wilderness EMS, than urban.
 

Methylprednisolone Sodium Succinate for Injection, USP         Currently in Shortage

This is an important drug for reactive airway conditions.
 

Nitrous Oxide, Gas         Currently in Shortage

A lot of people are uncomfortable with the idea of using nitrous oxide, but it is safe – as long as there is good circulation of fresh air.
 

Pantoprazole (Protonix) Powder for Injection         Currently in Shortage

This is usually not the part of allergic reaction that EMS treats, but it can be helpful.
 

Potassium Chloride Injection         Currently in Shortage

Not generally prehospital EMS, but interfacility.
 

Procainamide Hydrochloride Injection, USP         Currently in Shortage

This is an antiarrhythmic drug that actually works, but we tend to avoid it out of a lack of understanding and a lack of familiarity with the evidence.
 

Promethazine (Phenergan) Injection         Currently in Shortage
 

Ranitidine Injection, USP         Currently in Shortage
 

Rocuronium Bromide Injection         Currently in Shortage

Succinylcholine may end up as a shortage because of the rocuronium shortage.
 

Sodium Bicarbonate Injection, USP         Currently in Shortage

After calcium, sodium bicarbonate can be effective for hyperkalemia. Flush the line. Even better, use a different line for these incompatible medications.

We should not be wasting sodium bicarbonate in cardiac arrest patients, since it is not going to do anything to make things better, but it will make it more difficult to get sodium bicarbonate for the patients who can actually benefit.
 

Sodium Chloride 0.9% Injection Bags         Currently in Shortage

Do we really need to start as many IV (IntraVenous) lines with a drip?
 

Sodium Chloride 23.4% Injection         Currently in Shortage

Also effective for hyperkalemia, since it is the sodium that moves the potassium, not any myth of alkalinizing the patient.

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Filed Under: Drug Shortages, FDA, Pharmacology

2016 – Amiodarone is Useless, but Ketamine Gets Another Use

Sat, 31 Dec 2016 03:10:47 -0500 by
amiodarone-edit-1
 

I didn’t write a lot in 2016, but 2016 may have been the year we put the final nail in the coffin of amiodarone. Two major studies were published and both were very negative for amiodarone.

If we give enough amiodarone to have an effect on ventricular tachycardia, it will usually be a negative effect.[1]

Only 38% of ventricular tachycardia patients improved after amiodarone, but 48% had major adverse cardiac events after amiodarone.

There are better drugs, including adenosine, sotalol, procainamide, and ketamine for ventricular tachycardia. Sedation and cardioversion is a much better choice. Cardioversion is actually expected after giving amiodarone.

For cardiac arrest, amiodarone is not any better than placebo or lidocaine. What ever happened to the study of amiodarone that was showing such wonderful results over a decade ago? It still hasn’t been published, so it is reasonable to conclude that the results were negative for amiodarone. It is time to make room in the drug bag for something that works.[2],[3]

On the other hand, now that we have improved the quality of CPR by focusing on compressions, rather than drugs, more patients are waking up while chest compressions are being performed, but without spontaneous circulation, so ketamine has another promising use. And ketamine is still good for sedation for intubation, for getting a patient to tolerate high flow oxygen, for agitated delirium, for pain management, . . . .[4],[5]

Masimo’s RAD 57 still doesn’t have any evidence that it works well on real patients.[6]

When intubating, breathe. Breathing is good. Isn’t inability to breathe the reason for intubation?[7]

–

Footnotes:

–

[1] The PROCAMIO Trial – IV Procainamide vs IV Amiodarone for the Acute Treatment of Stable Wide Complex Tachycardia
Wed, 17 Aug 2016
Rogue Medic
Article

–

[2] Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest
Mon, 04 Apr 2016
Rogue Medic
Article

–

[3] Dr. Kudenchuk is Misrepresenting ALPS as ‘Significant’
Tue, 12 Apr 2016
Rogue Medic
Article

–

[4] What do you do when a patient wakes up during CPR?
Tue, 08 Mar 2016
Rogue Medic
Article

–

[5] Ketamine For Anger Management
Sun, 06 Mar 2016
Rogue Medic
Article

–

[6] The RAD-57 – Still Unsafe?
Wed, 03 Feb 2016
Rogue Medic
Article

–

[7] Should you hold your breath while intubating?
Tue, 19 Jan 2016
Rogue Medic
Article

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Filed Under: ACLS, Airway Management, CPR, Critical Judgment, Evidence, Excited Delirium, Heresy, Intubation, Ketamine, Masimo, Mythology, Pharmacology, Risk Management, Sedation, Toxicology

‘Narcan by Everyone’ Does Not Seem to be Such a Good Idea

Thu, 22 Dec 2016 22:45:48 -0500 by
 
Now that we have almost everyone giving naloxone (Narcan) to suspected heroin overdose patients, the fatality rate must have dropped. The panacea must have worked. My criticism of the Narcan by Everyone programs must have made me a laughing stock.[1],[2],[3],[4]

No.

Does that mean that I am a prophet and that you should worship me?

No.

Explanations exist; they have existed for all time; there is always a well-known solution to every human problem — neat, plausible, and wrong. H.L. Mencken.

I have been pointing out that the plans assumed that there would not be any unintended consequences. I explained what some of the unintended consequences would be. Many people used logical fallacies to justify ignoring the likelihood of unintended consequences. The reasonable thing to do would have been to study the implementation, so that problems would be noticed quickly.

Misdiagnosis – giving naloxone to people who have a change in level of consciousness that is not due to an opioid (heroin, fentanyl, carfentanyl, . . . ) overdose.
 

Six of the 25 complete responders to naloxone (24%) ultimately were proven to have had false-positive responses, as they were not ultimately given a diagnosis of opiate overdose. In four of these patients, the acute episode of AMS was related to a seizure, whereas in two, it was due to head trauma; in none of these cases did the ultimate diagnosis include opiates or any other class of drug overdose (which might have responded directly to naloxone). Thus, what was apparently misinterpreted as a response to naloxone in these cases appears in retrospect to have been due to the natural lightening that occurs with time during the postictal period or after head trauma.[5]

Bold highlighting is mine.

 

Failure to ventilate – not providing ventilations to a patient who is not breathing. These patients are often hypoxic (don’t have enough oxygen to maintain life) and hypercarbic (have too much carbon dioxide to maintain life). If the patient is alive, ventilation should keep the patient alive, even if naloxone is not given or if the naloxone is not effective. If the patient is dead, giving naloxone will not improve the outcome.[6]

But . . . But . . . But . . . Narcan is the miracle drug!
 


Image credit.
 

In Akron, a small Ohio city, medical examiner Dr. Lisa Kohler has seen over 50 people die of carfentanil since July. Police Lieutenant Rick Edwards says his officers are “giving four to eight doses of [naloxone] just to get a response.”[7]

 

“Every day our paramedics start CPR on someone surrounded by empty naloxone vials… people give the naloxone and walk away,” she (Ambulance Paramedics of BC president Bronwyn Barter) said in an interview.[7]

 

Where should we start?
 

All patients considered to have opioid intoxication should have a stable airway and adequate ventilation established before the administration of naloxone.[8]

 

We keep making excuses for solutions that are neat, plausible, and wrong. Why don’t we start acting like responsible medical professionals and do what is best for our patients?
 

Thank you to Gary Thompson of Agnotology for linking to this for me.

Go read Response: ‘What happens when drugs become too powerful for overdose kits’

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Footnotes:

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[1] The Myth that Narcan Reverses Cardiac Arrest
Wed, 12 Dec 2012 20:45:29
Rogue Medic
Article

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[2] Should Basic EMTs Give Naloxone (Narcan)?
Fri, 27 Dec 2013 14:00:22
Rogue Medic
Article

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[3] Is ‘Narcan by Everyone’ a Good Idea?
Tue, 03 Jun 2014 23:00:38
Rogue Medic
Article

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[4] Is First Responder Narcan the Same as First Responder AED?
Wed, 18 Jun 2014 17:15:43
Rogue Medic
Article

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[5] Acute heroin overdose.
Sporer KA.
Ann Intern Med. 1999 Apr 6;130(7):584-90. Review.
PMID: 10189329 [PubMed – indexed for MEDLINE]

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[6] The Kitchen Sink Approach to Cardiac Arrest
Mon, 16 Feb 2015 16:00:53
Rogue Medic
Article

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[7] What Happens When Drugs Become Too Powerful for Overdose Kits?
Dr. Blair Bigham
Oct 4 2016, 12:11pm
Article

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[8] Naloxone for the Reversal of Opioid Adverse Effects
Marcia L. Buck, PharmD, FCCP
Pediatr Pharm. 2002;8(8)
Medscape (free registration required?)
Clinical Uses

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Filed Under: Airway Management, Assessment, Critical Judgment, Fentanyl, Heresy, Heroin, Naloxone, Narcan, Pharmacology, Research, Risk Management
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