There are plenty who … claim to be competent at intubation even though their last intubation was months ago on the third attempt and if the patient had not already been dead – that would have finished the patient off …

- Rogue Medic

FDA bans useless, possibly dangerous, antibacterial soap ingredients

antiseptic soaps safe - qm - WSJ and FDA logo
 

As of September 6, 2017, The FDA (Food and Drug Administration) will ban manufacturers from selling antiseptic soaps over the counter to consumers because the manufacturers could not provide evidence that they work and that they are safe. The list of ingredients is in the footnotes.[1],[2]

In 2013, the FDA gave manufacturers a deadline to provide information about the products they sell to consumers. After decades of use, the manufacturers finally needed to provide evidence that the ingredients in their products are GRAS/GRAE. What does GRAS/GRAE mean?

GRAS = Generally Recognized As Safe
GRAE = Generally Recognized As Effective
GRAS/GRAE = Generally Recognized As Safe and Effective

As a consumer, do we want to spend our money on something that is not safe, is not effective, or is both unsafe and is ineffective?

Does the absence of evidence prove that the ingredients are unsafe or that they are ineffective? No.

The failure to provide evidence shows one of the following –

A. The manufacturers cannot show that the ingredients are safe.
B. The manufacturers cannot show that the ingredients are effective.
C. The manufacturers cannot show that the ingredients are safe and effective.

Those three are the most obvious possibilities, but there are several more possibilities. For example –

D. The manufacturers don’t care enough to find out if the ingredients are safe or effective.

Is it a business decision that the amount of money to be made in this multi-billion dollar market is not worth the amount of money that would be lost, but would any money be lost? Is the failure to provide evidence essentially an admission that the antibacterial soaps are just a marketing gimmick? Have the manufacturers avoided providing evidence? No.

Is there an absence of information? No. There is plenty of evidence, but the evidence does not show benefit or safety.
 

Both sides in the debate have submitted reams of evidence to the FDA supporting their stance, offering up conflicting studies that make it a challenge for the average consumer to make informed decisions.[3]

 

The more conspiratorial would add some other possibilities –

E. The manufacturers can show that the ingredients are not safe.
F. The manufacturers can show that the ingredients are not effective.
G. The manufacturers can show that the ingredients are not safe and not effective.

These are not impossible, but should we assume that manufacturers are intentionally and maliciously marketing dangerous and useless products? Hanlon’s razor addresses this –

Never attribute to malice that which is adequately explained by stupidity.

Stupidity does not appear to be the right word for this situation. There is another version of Hanlon’s razor that seems to be written just for the those who think that a lack of evidence of harm is the same as safety and efficacy.

Don’t assume bad intentions over neglect and misunderstanding.
 

How different is this from medical treatments that have no evidence of efficacy or safety? We stopped using backboards to stabilize the spine, atropine for cardiac arrest, furosemide for CHF, . . . , and we may no longer be able to justify using amiodarone.

Footnotes:

[1] FDA issues final rule on safety and effectiveness of antibacterial soaps – Rule removes triclosan and triclocarban from over-the-counter antibacterial hand and body washes
FDA (Food and Drug Administration)
For Immediate Release
September 2, 2016
FDA News Release

[2] Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
A Rule by the Food and Drug Administration on 09/06/2016
Final rule.

What ingredients are banned?

Thus, the following active ingredients are not GRAS/GRAE for use as a consumer antiseptic wash:
    *Cloflucarban
    *Fluorosalan
    *Hexachlorophene
    *Hexylresorcinol
    *Iodophors (Iodine-containing ingredients)
○ Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
○ Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
○ Nonylphenoxypoly (ethyleneoxy) ethanoliodine
○ Poloxamer—iodine complex
○ Povidone-iodine 5 to 10 percent
○ Undecoylium chloride iodine complex
    *Methylbenzethonium chloride
    *Phenol (greater than 1.5 percent)
    *Phenol (less than 1.5 percent)
    *Secondary amyltricresols
    *Sodium oxychlorosene
    *Tribromsalan
    *Triclocarban
    *Triclosan
    *Triple dye
Accordingly, OTC consumer antiseptic wash drug products containing these active ingredients are misbranded, and are new drugs for which approved new drug applications are required for marketing.

IV. Ingredients Not Generally Recognized as Safe and Effective

[3] Are Antibacterial Soaps Safe? Companies say there’s no cause for alarm, but studies suggest they may be dangerous. Now the FDA is preparing to rule.
Wall Street Journal
By Laura Landro
Updated Feb. 15, 2016 11:01 p.m. ET
Article

.

New Illinois state law will allow basic EMTs to inject epinephrine

 
EpiPen 1 from Bloomberg dot com
Image from Bloomberg.com.
 

0.15 mg (0.15 ml of 1 mg/ml epinephrine) for a child.
0.3 mg (0.3 ml of 1 mg/ml epinephrine) for an adult.
Inject deep into the side of the thigh.
This should not be complicated, but . . . .

Paramedics have generally been able to give epinephrine injections for anaphylaxis in Illinois and elsewhere. As of January 1, 2017, basic EMTs (Emergency Medical Technicians) in Illinois, who have been able to use the EpiPen autoinjector, will be able to give epinephrine injections the same way paramedics give epinephrine for anaphylaxis.[1],[2]

Why? The cost of the autoinjector has increased from around $100 to around $600 since 2007, when Mylan bought the EpiPen as part of a group of products from Merck. During that time, the packaging has gone from a single EpiPen to two EpiPens, so that may be one part of the increase.

The EpiPen, which is currently only made by Mylan, used to have competition from Sanofi. On October 30, 2015, Sanofi recalled their Auvi-Q autoinjectors due to the possibility of dosage inaccuracies.[3] Some people are claiming that the increase in cost is due to the withdrawal of this competitor from the market, but I was able to locate two other competitors in the US, so there is competition.

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.

If only the Sanofi recall caused the price increase, the price would not have been increasing for the past 10 years, but only for the past 10 months. Here is a graph of the price increase before the Sanofi recall.
 

EpiPen 2 from Bloomberg dot com
Graph from September 2015 – before the Sanofi recall – from Bloomberg.com.[4]
 

There are other competitors out there. Adrenaclick by Amedra Pharmaceuticals LLC,[5] and epinephrine injection, USP auto-injector by Lineage Therapeutics Inc.[6] – both located in Horsham, PA and the web sites have the same design, so they may be manufactured in the same facility.
 

The problems with having basic EMTs giving epinephrine injections are that the education has to be very good and the oversight has to be aggressive. As with naloxone (Narcan), doctors, nurses, and paramedics often give the drug inappropriately, so we know that there is a lot of potential for error.

The closest children’s hospital only uses autoinjectors, because they do not allow the nurses to draw up epinephrine for anaphylaxis. They probably do not allow the doctors to either, but I did not ask.

How bad are doctors at diagnosing and treating anaphylaxis?
 

Senior house officers (SHOs) (n=78) at the start of their accident and emergency (A&E) post were given an anonymous five case history questionnaire, containing one case of true anaphylaxis, and asked to complete the medication they would prescribe. In the case of anaphylaxis, 100% would administer adrenaline (epinephrine) but 55% would do so by the incorrect route. In the remaining cases, 10%–56% would be prepared to administer adrenaline inappropriately. Only 5% were able to indicate the correct route and dose of adrenaline according to Resuscitation Council guidelines (UK). This has implications for training as the survey took place before the start of the A&E posting. Anaphylaxis is over-diagnosed and poorly treated despite Resuscitation Council guidelines.[7]

 

That was in 2002. Have things improved?
 

RESULTS:
68 of 107 (64%) junior doctors completed the questionnaire. All recognised the need for adrenaline in anaphylaxis, but only 74% selected the correct intramuscular route, and 34% the correct route and dose. 82% of junior doctors would inappropriately give adrenaline to the patient who had inhaled a foreign body (case 2). A higher percentage of the 2013 cohort indicated the correct route and dose of adrenaline in anaphylaxis than their 2002 colleagues. However, a greater percentage also selected adrenaline treatment inappropriately in non-anaphylactic case scenarios.

CONCLUSIONS:
Despite updated guidelines, junior doctors continue to have poor knowledge about the recognition and management of anaphylaxis, with some still considering inappropriate intravenous adrenaline. More effort should be given to the recognition of anaphylaxis in early medical training.
[8]

 

Other research on doctors shows similar inability to come up with the right diagnosis, the right dose, and/or the right route of administration.[9],[10],[11] There are more. My anecdotal experience is that this is also a problem in the US with experienced paramedics and experienced physicians.

What about the King County epinephrine kit for basic EMTs?
 

King County epinephrine program to replace epipens 1 from Seattle Times
Image from the Seattle Times.
 

With training, EMTs in the program have learned to administer epinephrine efficiently and safely, he said. An EpiPen takes about 45 seconds to administer, start to finish. With the vial and syringe, it’s about 2 minutes, Duren said.[12]

 

As a paramedic, I am not going to be much faster.
 

“That sounds reasonable,” Reiter said. “For all but the most severe cases of anaphylaxis, a one-minute time lag is unlikely to make a difference.”[12]

 

The article suggests that King County is tracking their results carefully, which does not appear to be the case for EMS systems that have first responders giving naloxone. I would still like to see something published in a peer reviewed journal.

Footnotes:

[1] New state law will allow EMTs to inject epinephrine
Dan Petrella
The Southern Springfield Bureau
The Southern Illinoisan
Updated 22 hrs ago
Article

[2] New Ill. law to allow all EMTs to use syringes to administer epinephrine – The new law will allow EMTs with basic-level training to use a syringe to administer epinephrine
By EMS1 Staff
EMS1.com
Yesterday at 12:59 PM
Article

[3] UPDATED: Sanofi US Issues Voluntary Nationwide Recall of All Auvi-Q® Due to Potential Inaccurate Dosage Delivery
FDA (Food and Drug Administration – US)
For Immediate Release
October 30, 2015
Recall notice

[4] How Marketing Turned the EpiPen Into a Billion-Dollar Business – Mylan’s marketing turned the allergy device into a must-have.
Cynthia Koons and Robert Langreth
Bloomberg Businessweek
September 23, 2015 — 10:00 AM EDT
Article

[5] How to use Adrenaclick (epinephrine injection, USP auto-injector)
Adrenaclick by Amedra Pharmaceuticals LLC, Horsham, PA
Web site

[6] epinephrine injection, USP auto-injector
Lineage Therapeutics Inc., Horsham, PA
Web site

[7] Proposed use of adrenaline (epinephrine) in anaphylaxis and related conditions: a study of senior house officers starting accident and emergency posts.
Gompels LL, Bethune C, Johnston SL, Gompels MM.
Postgrad Med J. 2002 Jul;78(921):416-8.
PMID: 12151658

Free Full Text from PubMed Central.

[8] Correct recognition and management of anaphylaxis: not much change over a decade.
Plumb B, Bright P, Gompels MM, Unsworth DJ.
Postgrad Med J. 2015 Jan;91(1071):3-7. doi: 10.1136/postgradmedj-2013-132181.
PMID: 25573132

Free Full Text from Postgrad Med J.

[9] Survey of the use of epinephrine (adrenaline) for anaphylaxis by junior hospital doctors.
Jose R, Clesham GJ.
Postgrad Med J. 2007 Sep;83(983):610-1.
PMID: 17823230

Free Full Text from PubMed Central

[10] Anaphylaxis: lack of hospital doctors’ knowledge of adrenaline (epinephrine) administration in adults could endanger patients’ safety.
Droste J, Narayan N.
Eur Ann Allergy Clin Immunol. 2012 Jun;44(3):122-7.
PMID: 22905594

[11] Treatment of a simulated child with anaphylaxis: an in situ two-arm study.
O’Leary FM, Hokin B, Enright K, Campbell DE.
J Paediatr Child Health. 2013 Jul;49(7):541-7. doi: 10.1111/jpc.12276. Epub 2013 Jun 12.
PMID: 23758136

Free Full Text from J Paediatr Child Health.

 

RESULTS:
Fifty-six junior medical staff participated (90% participation rate). Only 50% of participants administered adrenaline in scenarios of definite anaphylaxis. Adrenaline was more likely to be administered if the scenario included hypotension, where the junior medical officer had previous formal resuscitation training (Advanced Paediatric Life Support) and by medical officers with more years of training.

CONCLUSION:
Anaphylaxis is a life-threatening presentation and requires prompt recognition and appropriate adrenaline administration. Junior medical staff may require more emphasis on recognition and prompt adrenaline administration in both undergraduate and in hospital training and education. Simulated scenarios may provide a platform to deliver this training to ultimately improve patient care.

 

[12] King County drops EpiPen for cheaper kit with same drug
By JoNel Aleccia
Seattle Times health reporter
Originally published January 14, 2015 at 10:05 pm
Updated January 15, 2015 at 7:00 pm
Seattle Times
Article

.

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

ResearchBlogging.org
 

This is a very interesting trial that may surprise the many outspoken amiodarone advocates, but it should not surprise anyone who pays attention to research.

ALPS showed that we should stop giving amiodarone for unwitnessed shockable cardiac arrest. The lead researcher is still trying to spin amiodarone for witnessed shockable cardiac arrest, even though the results do not show improvement in the one outcome that matters – leaving the hospital with a brain that still works.[1],[2],[3]

There is an excellent discussion of the study on the podcast by Dr. Salim Rezaie and Dr. Anand Swaminathan REBELCast: The PROCAMIO Trial – IV Procainamide vs IV Amiodarone for the Acute Treatment of Stable Wide Complex Tachycardia.

One problem with the study that they do not address on the podcast is that the patients in the study appear to have had time to watch Casablanca before treatment started. Here’s looking at you, while we’re waiting, kid. This is apparently unintentional one way of doing a placebo washout. If we wait long enough . . . .
 

Time from arrival to start of infusion was 87 ± 21 min for procainamide and 115 ± 36 min for amiodarone patients (P = 0.58).[4]

 

If nothing else, this demonstrates how little we need to worry about immediately pushing drugs for stable monomorphic VT (V Tach or Ventricular Tachycardia). Should we expect much from antiarrhythmic treatment?

Research shows that for stable monomorphic VT (V Tach or Ventricular Tachycardia) amiodarone is not very likely to be followed by an improvement. Only 29%[5] or only 25%[6] or only 15% within 20 minutes, but if we don’t mind waiting an hour it can be as much as 29%.[7] For those of you who are not good at math, that means amiodarone is about the same as doing nothing, only it comes in a syringe. Even though these poor outcomes ignore the side effects, they are the best evidence in favor of amiodarone, so what Kool-Aid are the advocates drinking?

Adenosine, yes adenosine the SVT (SupraVentricular Tachycardia) drug, appears to be more effective at treating ventricular tachycardia than amiodarone – and adenosine is faster and safer than amiodarone.[8]

What if the patient becomes unstable? First start an IV (IntraVenous) line. Then sedate the patient. Then apply defibrillator pads. After the patient is adequately sedated, then cardiovert. We do not need the pads on the patient first. If it takes a while to put the pads on, that is a problem with the ability of the doctors and nurses, not a medical problem.

It does not appear as if any patient received amiodarone or procainamide until after waiting in the ED (Emergency Department) for over an hour. Were some patients cardioverted in well under an hour? Probably. The important consideration is that the doctors and nurses be able to apply the defibrillator pads properly and quickly and deliver a synchronized cardioversion in less than a minute. If the patient has not yet been sedated, the cardioversion should be delayed until after the patient is adequately sedated, so the intervention that depends most on time is the sedation of the patient.
 

VT + Amiodarone Cardioversion
 

Is there a better treatment than amiodarone? Sedate the patient before the patient becomes unstable, then cardiovert. How do the MACEs (Major Adverse Cardiac Events) compare with sedation and cardioversion vs. antiarrhythmic treatment.
 

5.4 Proarrhythmia
Amiodarone may cause a worsening of existing arrhythmias or precipitate a new arrhythmia. Proarrhythmia, primarily torsade de pointes (TdP), has been associated with prolongation, by intravenous amiodarone, of the QTc interval to 500 ms or greater. Although QTc prolongation occurred frequently in patients receiving intravenous amiodarone, TdP or new-onset VF occurred infrequently (less than 2%). Monitor patients for QTc prolongation during infusion with amiodarone. Reserve the combination of amiodarone with other antiarrhythmic therapies that prolong the QTc to patients with life-threatening ventricular arrhythmias who are incompletely responsive to a single agent.
[9]

 

All antiarrhythmic drugs can cause arrhythmias. In the absence of information about a specific problem that is best addressed by a specific drug (amiodarone is the opposite of specific), we should avoid treatments that have such a high potential for harm.

Amiodarone doesn’t even do a good job of preventing arrhythmias.
 

Intravenous amiodarone did not prevent induction of sustained ventricular tachycardia in any of five patients inducible at baseline. Of six patients with non-sustained ventricular tachycardia, five had sustained ventricular tachycardia or fibrillation induced after amiodarone infusion.[10]

 

Is anything worse than amiodarone? Even epinephrine, yes epinephrine the inadequately tested cardiac arrest drug, has been followed by improved outcomes from V Tach after amiodarone failed.[11]
 

What is best for the patient?

Sedation, search for reversible causes, apply defibrillator pads, and be prepared to cardiovert.

Maybe sedation isn’t that important? This is by Dr. Peter Kowey, one of the top cardiologists in the world.
 

The man’s very first utterance was, “If it happens again, just let me die.”

As I discovered, the reason for this patient’s terror was that he had been cardioverted in an awake state. Ventricular tachycardia had been relatively slow, he had not lost consciousness, and the physicians, in the heat of the moment, had not administered adequate anesthesia. Although the 5 mg of intravenous diazepam had made him a bit drowsy, he felt the electric current on his chest and remembered the event clearly.

The patient’s mental state complicated the case considerably.[12]

 

How unimportant is sedation? How unimportant is consent?

For sedation, I would recommend ketamine, but etomidate was recommended in the podcast. Both work quickly and the most important obstacle to immediate treatment of a patient who suddenly deteriorates is the time to effect of sedation. Neither drug is expected to interfere with perfusion, which is the main excuse given for avoiding sedation for cardioversion.

This study is very small (not the fault of the authors), but it adds to the evidence that amiodarone is not a good first treatment for the patient.
 

Go listen to the podcast by Dr. Salim Rezaie and Dr. Anand Swaminathan REBELCast: The PROCAMIO Trial – IV Procainamide vs IV Amiodarone for the Acute Treatment of Stable Wide Complex Tachycardia

 

Over the years, I have written a bit about cardioversion and the importance of sedation –

Cardioversion – I’m not doing that, you do it! – Mon, 24 Mar 2008

Cardioversion – 2010 ACLS – Part I – Mon, 25 Oct 2010

Cardioversion – 2010 ACLS – Part II – Sun, 31 Oct 2010

Cardioversion – 2010 ACLS – Part III – Thu, 11 Nov 2010

On the relative wisdom of synchronized cardioversion without sedation – Part I – Thu, 11 Nov 2010

On the relative wisdom of synchronized cardioversion without sedation – Part II – Fri, 12 Nov 2010

Synchronized Cardioversion Without Sedation – Part II Scallywag’s Response – Sun, 14 Nov 2010

On the relative wisdom of synchronized cardioversion without sedation – Part III – Tue, 16 Nov 2010

On the relative wisdom of synchronized cardioversion without sedation – Part IV – Wed, 24 Nov 2010

Comments on Cardioversion – 2010 ACLS – Part II – Mon, 16 Apr 2012
 

I have also written a bit about amiodarone –

Merit Badge Courses, Amiodarone, and tPA – Fri, 17 Sep 2010

Amiodarone for Cardiac Arrest in the 2010 ACLS – Part I – Wed, 01 Dec 2010

Amiodarone for Cardiac Arrest in the 2010 ACLS – Part II – Fri, 03 Dec 2010

Is Nexterone the Next Amiodarone? – Sat, 04 Dec 2010

Amiodarone for Cardiac Arrest in the 2010 ACLS – Part III – Mon, 06 Dec 2010

Where are the Black Box Warnings on These Drugs – I – Mon, 05 Dec 2011

Where are the Black Box Warnings on These Drugs – II – Sun, 11 Dec 2011

Is Amiodarone the Best Drug for Stable Ventricular Tachycardia – Wed, 14 Dec 2011

V Tach Storm – Part I – Wed, 28 Dec 2011

V Tach Storm – Part II – Thu, 29 Dec 2011

Nifekalant versus lidocaine for in-hospital shock-resistant ventricular fibrillation or tachycardia – Wed, 04 Jan 2012

NIH launches trials to evaluate CPR and drugs after sudden cardiac arrest – Sun, 29 Jan 2012

What Will Be the Next Standard Of Care We Eliminate – Wed, 28 Mar 2012

Happy Adenosine Day – Tue, 12 Jun 2012

Too Much Medicine and Evidence-Based Guidelines – Part I – Tue, 26 Jun 2012

Too Much Medicine and Evidence-Based Guidelines – Part II – Tue, 03 Jul 2012

Ondansetron (Zofran) Warning for QT Prolongation – is Amiodarone next? – Part I – Mon, 02 Jul 2012

Ondansetron (Zofran) Warning for QT Prolongation – is Amiodarone next? – Part II – Thu, 05 Jul 2012

Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium – Part I – Mon, 17 Sep 2012

Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium – Part II – Tue, 18 Sep 2012

How do we measure the QT segment when there are prominent U waves? – Thu, 13 Dec 2012

Woman with Risks for Torsades de Pointes Dying within Hours of Leaving the Emergency Department – Wed, 02 Jan 2013

Examples of Ventricular Tachycardia Caused by Amiodarone – Part I – Tue, 28 May 2013

Publication Bias – The Lit Whisperers – Tue, 11 Jun 2013

Standards Of Care – Ventricular Tachycardia – Wed, 31 Jul 2013

Footnotes:

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

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

[3] Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest.
Kudenchuk PJ, Brown SP, Daya M, Rea T, Nichol G, Morrison LJ, Leroux B, Vaillancourt C, Wittwer L, Callaway CW, Christenson J, Egan D, Ornato JP, Weisfeldt ML, Stiell IG, Idris AH, Aufderheide TP, Dunford JV, Colella MR, Vilke GM, Brienza AM, Desvigne-Nickens P, Gray PC, Gray R, Seals N, Straight R, Dorian P; Resuscitation Outcomes Consortium Investigators.
N Engl J Med. 2016 May 5;374(18):1711-22. doi: 10.1056/NEJMoa1514204. Epub 2016 Apr 4.
PMID: 27043165

CONCLUSIONS
Overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo among patients with out-of-hospital cardiac arrest due to initial shock-refractory ventricular fibrillation or pulseless ventricular tachycardia.

[4] Randomized comparison of intravenous procainamide vs. intravenous amiodarone for the acute treatment of tolerated wide QRS tachycardia: the PROCAMIO study.
Ortiz M, Martín A, Arribas F, Coll-Vinent B, Del Arco C, Peinado R, Almendral J; PROCAMIO Study Investigators.
Eur Heart J. 2016 Jun 28. pii: ehw230. [Epub ahead of print]
PMID: 27354046

Free Full Text from European Heart Journal.

[5] Amiodarone or procainamide for the termination of sustained stable ventricular tachycardia: an historical multicenter comparison.
Marill KA, deSouza IS, Nishijima DK, Senecal EL, Setnik GS, Stair TO, Ruskin JN, Ellinor PT.
Acad Emerg Med. 2010 Mar;17(3):297-306.
PMID: 20370763 [PubMed – indexed for MEDLINE]

Free Full Text from Academic Emergency Medicine.

[6] Amiodarone is poorly effective for the acute termination of ventricular tachycardia.
Marill KA, deSouza IS, Nishijima DK, Stair TO, Setnik GS, Ruskin JN.
Ann Emerg Med. 2006 Mar;47(3):217-24. Epub 2005 Nov 21.
PMID: 16492484 [PubMed – indexed for MEDLINE]

[7] Intravenous amiodarone for the pharmacological termination of haemodynamically-tolerated sustained ventricular tachycardia: is bolus dose amiodarone an appropriate first-line treatment?
Tomlinson DR, Cherian P, Betts TR, Bashir Y.
Emerg Med J. 2008 Jan;25(1):15-8.
PMID: 18156531 [PubMed – indexed for MEDLINE]

[8] Adenosine for wide-complex tachycardia – diagnostic?
Thu, 23 Aug 2012
Rogue Medic
Article

[9] AMIODARONE HYDROCHLORIDE- amiodarone hydrochloride injection, solution
DailyMed
5 WARNINGS AND PRECAUTIONS
FDA Label

[10] Effects of intravenous amiodarone on ventricular refractoriness, intraventricular conduction, and ventricular tachycardia induction.
Kułakowski P, Karczmarewicz S, Karpiński G, Soszyńska M, Ceremuzyński L.
Europace. 2000 Jul;2(3):207-15.
PMID: 11227590 [PubMed – indexed for MEDLINE]

Free Full Text PDF + HTML from Europace

[11] Low doses of intravenous epinephrine for refractory sustained monomorphic ventricular tachycardia.
Bonny A, De Sisti A, Márquez MF, Megbemado R, Hidden-Lucet F, Fontaine G.
World J Cardiol. 2012 Oct 26;4(10):296-301. doi: 10.4330/wjc.v4.i10.296.
PMID: 23110246 [PubMed]

Free Full Text from PubMed Central.

[12] The calamity of cardioversion of conscious patients.
Kowey PR.
Am J Cardiol. 1988 May 1;61(13):1106-7. No abstract available.
PMID: 3364364

Kudenchuk PJ, Brown SP, Daya M, Rea T, Nichol G, Morrison LJ, Leroux B, Vaillancourt C, Wittwer L, Callaway CW, Christenson J, Egan D, Ornato JP, Weisfeldt ML, Stiell IG, Idris AH, Aufderheide TP, Dunford JV, Colella MR, Vilke GM, Brienza AM, Desvigne-Nickens P, Gray PC, Gray R, Seals N, Straight R, Dorian P, & Resuscitation Outcomes Consortium Investigators (2016). Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest. The New England journal of medicine, 374 (18), 1711-22 PMID: 27043165

Ortiz M, Martín A, Arribas F, Coll-Vinent B, Del Arco C, Peinado R, Almendral J, & PROCAMIO Study Investigators (2016). Randomized comparison of intravenous procainamide vs. intravenous amiodarone for the acute treatment of tolerated wide QRS tachycardia: the PROCAMIO study. European heart journal PMID: 27354046

Marill KA, deSouza IS, Nishijima DK, Senecal EL, Setnik GS, Stair TO, Ruskin JN, & Ellinor PT (2010). Amiodarone or procainamide for the termination of sustained stable ventricular tachycardia: an historical multicenter comparison. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 17 (3), 297-306 PMID: 20370763

Marill KA, deSouza IS, Nishijima DK, Stair TO, Setnik GS, & Ruskin JN (2006). Amiodarone is poorly effective for the acute termination of ventricular tachycardia. Annals of emergency medicine, 47 (3), 217-24 PMID: 16492484

Tomlinson DR, Cherian P, Betts TR, & Bashir Y (2008). Intravenous amiodarone for the pharmacological termination of haemodynamically-tolerated sustained ventricular tachycardia: is bolus dose amiodarone an appropriate first-line treatment? Emergency medicine journal : EMJ, 25 (1), 15-8 PMID: 18156531

Kułakowski P, Karczmarewicz S, Karpiński G, Soszyńska M, & Ceremuzyński L (2000). Effects of intravenous amiodarone on ventricular refractoriness, intraventricular conduction, and ventricular tachycardia induction. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2 (3), 207-15 PMID: 11227590

Bonny A, De Sisti A, Márquez MF, Megbemado R, Hidden-Lucet F, & Fontaine G (2012). Low doses of intravenous epinephrine for refractory sustained monomorphic ventricular tachycardia. World journal of cardiology, 4 (10), 296-301 PMID: 23110246

Kowey PR (1988). The calamity of cardioversion of conscious patients. The American journal of cardiology, 61 (13), 1106-7 PMID: 3364364

.

Acupuncture vs intravenous morphine in the management of acute pain in the ED

ResearchBlogging.org
 

What does elaborate placebo mean?

An elaborate placebo is a placebo that does better than a pill, or injection, apparently because the patient has more invested in the belief the placebo will work. An injection of a placebo (saline solution) may be more effective than a pill of real pain medicine because of the ceremony involved in giving the placebo through IV (IntraVenous) access. A placebo that is more expensive tends to have more of an effect than a less expensive placebo.[1],[2]

Acupuncture requires a lot of investment on the part of the patient. A more elaborate placebo might be fire walking. I don’t know of any research on fire walking as a treatment for pain, but I would not be surprised if it is extremely effective.
 

fire walking 1
Image credit. Do not try at home.
 

We know that acupuncture is just a placebo because research shows that sham (fake/placebo) acupuncture works just as well as real acupuncture. Sham acupuncture generally means using toothpicks (rather than needles), not penetrating the skin, but always using locations that are not qi points.[3],[4],[5]

If the essence of acupuncture is the magic of the qi points, but the same effect is produced when staying away from the qi points, the qi points aren’t doing anything.

This study did not use a sham acupuncture group. We have no reason to expect real acupuncture to provide more pain relief than sham acupuncture, so how should we use this information?

Should we have people providing fake acupuncture in the ED (Emergency Department)?

If so, how should we do this?

Since it is not the acupuncture, but the patient’s reaction to the ceremony of the placebo that appears to be providing the pain relief, how many different ways might we vary the treatment to improve the placebo effect?

Should we set up a fire walking pit?

What are the ethical concerns of using placebo medicine, when the placebo appears to provide similar, but safer, relief than real medicine?

What are the ethical concerns of using deception to treat patients?
 

Acupuncture versus intravenous morphine in the management of acute pain in the emergency department 1 with caption
 

Overall, 89 patients (29.3%) experienced minor adverse effects: 85 (56.6%) in morphine group and 4 (2.6%) in acupuncture group; the difference was signi ficant between the 2 groups (Table 3). The most frequent adverse effect was dizziness in the morphine group (42%) and needle breakage in the acupuncture group (2%). No major adverse effect was recorded during the study protocol. (See Table 4.)[6]

 

If we ignore the problems with this study and with the problem of lying to patients to make them feel better, can we expect research journals to look more like alternative medicine magazines with article titles like –

How to lie to patients, so that . . . .

What is the best scam to relieve pain?

How much integrity do we sacrifice?

Since the ED does not appear to be the source of the increase in opioid addiction, should we sacrifice any integrity in pursuit of placebo treatments?

We have an epidemic of opioid addiction because of excessive prescriptions for long-term pain.

The answer is not to try to create an epidemic of magical thinking.
 

This paper was also covered by –

Emergency Medicine Literature of Note

NEJM Journal Watch Emergency Medicine

Life in the Fast Lane

Science-Based Medicine

And thank you to Dr. Ryan Radecki of Emergency Medicine Literature of Note for providing me with a copy of the paper.

Footnotes:

[1] Placebo effect of medication cost in Parkinson disease: a randomized double-blind study.
Espay AJ, Norris MM, Eliassen JC, Dwivedi A, Smith MS, Banks C, Allendorfer JB, Lang AE, Fleck DE, Linke MJ, Szaflarski JP.
Neurology. 2015 Feb 24;84(8):794-802. doi: 10.1212/WNL.0000000000001282. Epub 2015 Jan 28.
PMID: 25632091

Free Full Text from PubMed Central

[2] Commercial features of placebo and therapeutic efficacy.
Waber RL, Shiv B, Carmon Z, Ariely D.
JAMA. 2008 Mar 5;299(9):1016-7. doi: 10.1001/jama.299.9.1016. No abstract available.
PMID: 18319411

Free Full Text in PDF format from Duke.edu

[3] Acupuncture for Menopausal Hot Flashes: A Randomized Trial.
Ee C, Xue C, Chondros P, Myers SP, French SD, Teede H, Pirotta M.
Ann Intern Med. 2016 Feb 2;164(3):146-54. doi: 10.7326/M15-1380. Epub 2016 Jan 19.
PMID: 26784863

Free Full Text in PDF format from carolinashealthcare.org

[4] A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain.
Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA.
Arch Intern Med. 2009 May 11;169(9):858-66. doi: 10.1001/archinternmed.2009.65.
PMID: 19433697

Free Full Text from PubMed Central

[5] Acupuncture for treatment of persistent arm pain due to repetitive use: a randomized controlled clinical trial.
Goldman RH, Stason WB, Park SK, Kim R, Schnyer RN, Davis RB, Legedza AT, Kaptchuk TJ.
Clin J Pain. 2008 Mar-Apr;24(3):211-8.
PMID: 18287826 [PubMed – indexed for MEDLINE]

[6] Acupuncture vs intravenous morphine in the management of acute pain in the ED.
Grissa MH, Baccouche H, Boubaker H, Beltaief K, Bzeouich N, Fredj N, Msolli MA, Boukef R, Bouida W, Nouira S.
Am J Emerg Med. 2016 Jul 20. pii: S0735-6757(16)30422-3. doi: 10.1016/j.ajem.2016.07.028. [Epub ahead of print]
PMID: 27475042

ClinicalTrials.gov page for this study.

Grissa, M., Baccouche, H., Boubaker, H., Beltaief, K., Bzeouich, N., Fredj, N., Msolli, M., Boukef, R., Bouida, W., & Nouira, S. (2016). Acupuncture vs intravenous morphine in the management of acute pain in the ED The American Journal of Emergency Medicine DOI: 10.1016/j.ajem.2016.07.028

Espay, A., Norris, M., Eliassen, J., Dwivedi, A., Smith, M., Banks, C., Allendorfer, J., Lang, A., Fleck, D., Linke, M., & Szaflarski, J. (2015). Placebo effect of medication cost in Parkinson disease: A randomized double-blind study Neurology, 84 (8), 794-802 DOI: 10.1212/WNL.0000000000001282

Waber RL, Shiv B, Carmon Z, Ariely D. (2008). Commercial Features of Placebo and Therapeutic Efficacy JAMA, 299 (9) DOI: 10.1001/jama.299.9.1016

Ee, C., Xue, C., Chondros, P., Myers, S., French, S., Teede, H., & Pirotta, M. (2016). Acupuncture for Menopausal Hot Flashes Annals of Internal Medicine, 164 (3) DOI: 10.7326/M15-1380

Cherkin, D., Sherman, K., Avins, A., Erro, J., Ichikawa, L., Barlow, W., Delaney, K., Hawkes, R., Hamilton, L., Pressman, A., Khalsa, P., & Deyo, R. (2009). A Randomized Trial Comparing Acupuncture, Simulated Acupuncture, and Usual Care for Chronic Low Back Pain Archives of Internal Medicine, 169 (9) DOI: 10.1001/archinternmed.2009.65

Goldman, R., Stason, W., Park, S., Kim, R., Schnyer, R., Davis, R., Legedza, A., & Kaptchuk, T. (2008). Acupuncture for Treatment of Persistent Arm Pain Due to Repetitive Use The Clinical Journal of Pain, 24 (3), 211-218 DOI: 10.1097/AJP.0b013e31815ec20f

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Is EMS a Trade or a Profession?

 

In the current issue of JEMS, there is an article by Dr. Bryan Bledsoe that does an excellent job of identifying many of the problems with low standards in EMS – at least if the quality of care is important.
 

Also, if you will note, the welding curriculum was revised in 2011.

The paramedic curriculum was last revised in 2009. Which trades would you say have had the most changes in the last eight to 10 years? Certainly changes in EMS have occurred much more frequently and are much more significant than those that have occurred in welding.[1]

 
trade vs profession 1

 
In some places, EMS has been more aggressive in changing treatment guidelines/protocols to improve the care delivered to patients. In other places, change has been resisted.

Backboards are rarely used in the places that have admitted that we do not have any valid evidence that backboards improve outcomes, while we do have good evidence that backboards cause harm. Even more important is the evidence that manipulating the patient’s spine in order to stabilize the spine is wishful thinking that encourages us to do exactly what we claim to be trying to prevent.

High dose NTG (NiTroGlycerin – GTN GlycerylTriNitrate in Commonwealth countries) is becoming much more widely used for acute CHF/ADHF (Acute Decompensated Heart Failure), because high dose NTG dramatically improves survival and decreases the perceived need for aggressive airway manipulation.

Likewise, furosemide is being eliminated from the CHF/ADHF guidelines/protocols, because furosemide does not do what it is supposed to do and furosemide causes harm that it is not supposed to cause.

Ketamine is becoming the drug for many indications. Ketamine may be the best sedative, best analgesic, best agitated delirium treatment available to EMS.

How do we know that we have been harming patients?

Enough people stopped listening to the old timers, the QA/QI/CYA people who don’t understand quality, the brand new if it were dangerous, it wouldn’t be in the protocol people, and other opponents of quality care.

People are paying more attention to the evience, rather than making excuses for the absence of evidence.
 

What is important is whether or not the graduating paramedic is competent and ready to assume the important role of prehospital care.[1]

 

Many states use the NREMT (National Registry of EMTs) test to determine if a paramedic is ready to become a new hire paramedic with no experience, some day to be able to work without a supervisor present. Some states continue to require this babe in the woods test of outdated material as their goal for even experienced paramedics.

The NREMT is holding EMS back.
 

It is time for the national standard curriculum to go away. We must meet and decide what the core competencies of a paramedic will be. We must validate these core competencies through scientific study. Then, we should leave it up to the educators to determine how best to educate their students in these core competencies.[1]

 

The paramedic curriculum, revered by the NREMT, harms patients.

Why are we protecting a curriculum that harms patients?

Footnotes:

[1] Is EMS a Trade or a Profession?
Thu, Jul 28, 2016
ByBryan Bledsoe, DO, FACEP, FAAEM, EMT-P
JEMS Editorial Board member
Journal of EMS (JEMS)
Article

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When logic fails, throw propane on the fire?

 

Many of us have had discussions that became heated, because the other person would not see reason, we would not see reason, or neither of us would see reason. And that is if there are just two opinions involved.

Here is an article about someone who got a bit carried away with making his point and lost perspective.
 

A family argument over whether the Earth is flat or round became so heated that one of the participants threw a propane cylinder onto a campfire, prompting an intervention by firefighters.[1]

 

Flat Earth Hitler 1aa
 

I know. Dramatic, but harmless

Don’t worry.

Everybody knows that propane tanks have safety valves, so they don’t blow up.

Right?
 


 

It turns out that propane tanks do not share that opinion.

The following video does an excellent job of explaining why a full tank may take a while to explode. This is a BLEVE (Boiling Liquid Expanding Vapor Explosion), which any first responder should be familiar with. We should know enough to not throw, or even gently place, containers of flammable material on fires, unless intending to cause an explosion.
 


 

What about the topic of discussion? Is the earth flat?

Common sense tells us that the earth is flat.

Science, a systematic way for carefully and thoroughly observing nature and using consistent logic to evaluate results,[2] shows us that the earth is not quite flat.

There is an excellent short article explaining the way science has improved our understanding of the shape of the earth.
 

In the early days of civilization, the general feeling was that the earth was flat. This was not because people were stupid, or because they were intent on believing silly things. They felt it was flat on the basis of sound evidence. It was not just a matter of “That’s how it looks,” because the earth does not look flat. It looks chaotically bumpy, with hills, valleys, ravines, cliffs, and so on.[3]

 
 

Nowadays, of course, we are taught that the flat-earth theory is wrong; that it is all wrong, terribly wrong, absolutely. But it isn’t. The curvature of the earth is nearly 0 per mile, so that although the flat-earth theory is wrong, it happens to be nearly right. That’s why the theory lasted so long.[3]

 

There were observations that were not consistent with a flat earth. The rest of the article explains the way science showed us the more accurate answers.

Was the person right to throw a propane cylinder into a fire? No.

If the earth is not flat, does that mean that it is round? No.

Read The Relativity of Wrong and learn a bit about how science works and what it means to be wrong.

Footnotes:

[1] Police, firefighters called in after flat Earth debate turns heated – Man angered by suggestion Earth is flat threw propane tank into fire, police say
CBC News
Posted: Jun 14, 2016 5:09 PM ET
Last Updated: Jun 14, 2016 6:00 PM ET
Article

[2] Skeptical Quote of the Week
Quote by Dr. Steven Novella
The Skeptics’ Guide to the Universe
Podcast #410
May 25th, 2013
Synopsis
 

What do you think science is? There’s nothing magical about science. It is simply a systematic way for carefully and thoroughly observing nature and using consistent logic to evaluate results. Which part of that exactly do you disagree with? Do you disagree with being thorough? Using careful observation? Being systematic? Or using consistent logic? – Dr. Steven Novella.

 

[3] The Relativity of Wrong
By Isaac Asimov
The Skeptical Inquirer
Fall 1989, Vol. 14, No. 1, Pp. 35-44
Article from Tufts University

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Dr. Kudenchuk is Misrepresenting ALPS as ‘Significant’

ResearchBlogging.org
 

The results of ALPS (Amiodarone, Lidocaine, Placebo Study) are clear. There is no statistically significant difference in cardiac arrest outcomes with amiodarone or lidocaine, when compared with placebo.
 

Conclusions Overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo among patients with out-of-hospital cardiac arrest due to initial shock-refractory ventricular fibrillation or pulseless ventricular tachycardia.[1]

 

This study was very well done, but it was not designed to provide valid information about the effects of amiodarone or lidocaine on witnessed arrests or on EMS Witnessed arrests. Maybe the authors were overconfident.

In resuscitation research, we have abundant evidence that overconfidence is much more common than improvements in outcomes. There is no study that has shown an improvement in neurologically intact survival to discharge with any drug. Leaving the hospital with a working brain is the result that matters most to patients. We give drugs because we have too much confidence in the drugs and we are treating our confidence, not because we are doing anything to benefit the patients.
 

I WANT TO BE DECEIVED version of Domenichino, Virgin and Unicorn 1 copy
 

In ALPS there was a subgroup that might have reached statistical significance, but the researchers never determined what would be statistically significant when setting up the study, so these results are merely post hoc data mining (fitting the numbers to allow for a positive spin).

This is the Texas sharpshooter fallacy. The Texas sharpshooter shoots at the side of a barn, then draws targets around the bullet holes so that the the bullet holes are in the bull’s eyes.
 


 

The Texas sharpshooter didn’t shoot at any target, but he went back later and made it look like he hit the center of the target, because he drew the target around the bullet holes. Science requires that we state our hypotheses ahead of time, so that scientists are kept honest. Science requires that we calculate statistical significance ahead of time, especially for secondary outcomes/subgroup analysis, which may mean decreasing the p value to less than 0.03, or to less than 0.01, or even lower to reach statistical significance, so that scientists are kept honest. You are not permitted to bet on the outcome of a horse race that is already in progress for the same reason.

Why do we need to keep scientists honest? Because, as Dr. Peter Kudenchuk unintentionally demonstrates, scientists are just as biased as everyone else. Scientists need to follow the rules of science to minimize the influence of prejudices, such as overconfidence. When scientists do not follow these rules, they are just as easily fooled as everyone else and they may use that self-delusion, and their reputation, to fool others. Dr. Oz makes a fortune telling people what they want to hear about treatments that do not work.

I don’t claim that Dr. Kudenchuk, or even Dr. Oz, is deliberately fooling others, only that they have fooled themselves and are trying to convince others that their prejudices are accurate representations of reality. Here is what Dr. Kudenchuk has been telling people –
 

Researchers have confirmed that certain heart rhythm medications, when given by paramedics to patients with out-of-hospital cardiac arrest who had failed electrical shock treatment, improved likelihood of patients surviving transport to the hospital.[2]

 

The researchers have not confirmed any such thing.

If Dr. Kudenchuk wants to study whether amiodarone or lidocaine or both improve outcomes for witnessed cardiac arrest patients, or for EMS witnessed cardiac arrest patients, he needs to set up a study with all of the criteria for a positive result specified before the start of the study, because this study did not. The study explicitly states this, so Dr. Kudenchuk should be able to just read the study and see that he is wrong. Here is another statement that contradicts the information that was published.
 

Two groups of patients were pre-specified by the study as likely to respond differently to treatment: those with a witnessed cardiac arrest and those with an unwitnessed arrest. When it was originally designed, the study predicted that because patients with witnessed cardiac arrest are recognized and treated sooner, they would more likely be responsive to effective treatments than unwitnessed arrests. When first discovered, patients with an unwitnessed arrest are more likely to have already sustained irreversible organ damage resulting from a longer “down time” and less likely to respond to any treatment. This is precisely what was seen in the study – a statistically significant 5% improvement in survival to hospital discharge in witnessed arrests, and no effect from the drugs in unwitnessed arrests.[3]

 

Why does the published version of the paper contradict Dr. Kudenchuk? One of our biases is to remember things differently from the way things really happened. This is why eyewitness testimony is so often wrong. Here is what the published paper states about the witnessed arrest results.
 

We observed an interaction of treatment with the witnessed status of out-of-hospital cardiac arrest, which is often taken as a surrogate for early recognition of cardiac arrest, a short interval between the patient’s collapse from cardiac arrest and the initiation of treatment, and a greater likelihood of therapeutic responsiveness. Though prespecified, this subgroup analysis was performed in the context of an insignificant difference for the overall analysis, and the P value for heterogeneity in this subgroup analysis was not adjusted for the number of subgroup comparisons. Nonetheless, the suggestion that survival was improved by drug treatment in patients with witnessed out-of-hospital cardiac arrest, without evidence of harm in those with unwitnessed arrest, merits thoughtful consideration.[1]

 

The authors did not adjust the p value, so the authors do not claim that the witnessed cardiac arrest results are statistically significant. They only state that these results merit thoughtful consideration. In other words, if we want to claim this hypothesis is true, we need to set up a study to actually examine this hypothesis.

One earlier study (also by ROC – the Resuscitation Outcomes Consortium) even has similar results.[4],[5] These results are also not statistically significant, but suggest that with larger numbers the results might be significant. So why did the authors set up such a small study? Overconfidence and an apparent lack of familiarity with their own research.
 


 

The Seattle phenomenon (they claim that their resuscitation rate is the highest in America) seems to be due to excellent bystander CPR rates (apparently the highest in America), but that is only good enough for them to be experts on improving bystander CPR rates. The rest is probably due to defibrillation and chest compressions, which are the only prehospital interventions demonstrated to improve neurologically intact survival.

Why does a bystander CPR specialist focus on drugs? Overconfidence and an apparent lack of understanding of the resuscitation research. Dr. Kudenchuk preaches like Timothy Leary about the benefits of drugs and with just as little evidence. We should give appropriate credit for Dr. Kudenchuk’s work on CPR, but we should not mistake that for a thorough understanding of the resuscitation research, even the research with his name attached.
 

A new podcast reviews ALPS. Dominick Walenczak does not notice the mistakes of Dr. Kudenchuk, but he is not one of the researchers, so that is easy to overlook. The rest of the podcast is excellent. Listen to it here.
 

Episode 8: Conquering the ALPS (Study)
CritMedic – Critical Care Paramedicine Podcast
Dominick Walenczak
April 7, 2016
Podcast page
 

Footnotes:

[1] Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest.
Kudenchuk PJ, Brown SP, Daya M, Rea T, Nichol G, Morrison LJ, Leroux B, Vaillancourt C, Wittwer L, Callaway CW, Christenson J, Egan D, Ornato JP, Weisfeldt ML, Stiell IG, Idris AH, Aufderheide TP, Dunford JV, Colella MR, Vilke GM, Brienza AM, Desvigne-Nickens P, Gray PC, Gray R, Seals N, Straight R, Dorian P; Resuscitation Outcomes Consortium Investigators.
N Engl J Med. 2016 Apr 4. [Epub ahead of print]
PMID: 27043165

Free Full Text from NEJM

[2] Antiarrhythmic drugs found beneficial when used by EMS treating cardiac arrest
Press release
For Immediate Release:April 4, 2016
NHLBI (National Heart Lung and Blood Institute)
Press release

[3] Dr. Kudenchuk: Study reveals exciting news about cardiac arrest treatment
Lindsay Bosslet
18 hours ago
Public Health Insider
Article

[4] Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium.
Glover BM, Brown SP, Morrison L, Davis D, Kudenchuk PJ, Van Ottingham L, Vaillancourt C, Cheskes S, Atkins DL, Dorian P; Resuscitation Outcomes Consortium Investigators.
Resuscitation. 2012 Nov;83(11):1324-30. doi: 10.1016/j.resuscitation.2012.07.008. Epub 2012 Jul 31.
PMID: 22858552 [PubMed – indexed for MEDLINE]

Free Full Text from PubMed Central.

[5] Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium – Part I
Mon, 17 Sep 2012
Rogue Medic
Article

 
Kudenchuk, P., Brown, S., Daya, M., Rea, T., Nichol, G., Morrison, L., Leroux, B., Vaillancourt, C., Wittwer, L., Callaway, C., Christenson, J., Egan, D., Ornato, J., Weisfeldt, M., Stiell, I., Idris, A., Aufderheide, T., Dunford, J., Colella, M., Vilke, G., Brienza, A., Desvigne-Nickens, P., Gray, P., Gray, R., Seals, N., Straight, R., & Dorian, P. (2016). Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest New England Journal of Medicine DOI: 10.1056/NEJMoa1514204

 

Glover BM, Brown SP, Morrison L, Davis D, Kudenchuk PJ, Van Ottingham L, Vaillancourt C, Cheskes S, Atkins DL, Dorian P, & the Resuscitation Outcomes Consortium Investigators (2012). Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium. Resuscitation PMID: 22858552

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What do you do when a patient wakes up during CPR?

ResearchBlogging.org
 

The return of consciousness without the return of a pulse is still rare, but may be more common with our increased focus on high quality chest compressions. There is still no evidence that interrupting chest compressions, for anything other than defibrillation, improves outcomes.

Is this due to the consistency of the machine? Maybe. Maybe not. We do not have enough evidence to draw that conclusion.

Is this growing population really growing? Maybe. Maybe not. We do not have enough evidence to draw that conclusion, either.

It could be that with the ability to use a cell phone camera to record these instances, there is more credibility to the reports. There is a suggestion that this could be common.
 

Parnia et al. conducted a multi-year, multi-center, prospective study of the frequency of awareness during resuscitation by interviewing cardiac arrest survivors after discharge. They found 55/140 (39%) had perceptions of awareness of being alive and even memories that originated during that time.2 [1]

 

Should we be giving ketamine to these patients?
 

Nebraska EMS CPR Sedation Protocol - ALS
Nebraska CPR Induced Consciousness Sedation Protocol (from the PDF)[1]
 

We should find out how common it is for people to regain consciousness without regaining a pulse. This is clearly an experimental protocol that is not supported by evidence of improved outcomes that matter – just like all of the rest of cardiac arrest treatment that is not compressions or defibrillation.
 

RESULTS: The search yielded 1997 unique records, of which 50 abstracts were reviewed. Nine reports, describing 10 patients, were relevant. Six of the patients had CPR performed by mechanical devices, three of these patients were sedated. Four patients arrested in the out-of-hospital setting and six arrested in hospital. There were four survivors. Varying levels of consciousness were described in all reports, including purposeful arm movements, verbal communication, and resuscitation interference. Management strategies directed at consciousness were offered to six patients and included both physical and chemical restraints.[2]

 

6/1,997 is 0.3% – not anywhere near the 39.3% of 55/140, but it is still a large enough group that we should not ignore them.

Depression and anxiety following resuscitation are significant problems, so this might even be a way to help decrease those resuscitation side effects.
 

CONCLUSION:
One fourth of OHCA-survivors reported symptoms of anxiety and/or depression at 6 months which was similar to STEMI-controls and previous normative data. Subjective cognitive problems were associated with an increased risk for psychological distress. Since psychological distress affects long-term prognosis of cardiac patients in general it should be addressed during follow-up of survivors with OHCA due to a cardiac cause.
[3]

 

The similarity to the outcome of STEMI (ST segment Elevation Myocardial Infarction) patients do not inspire confidence in this approach, but that does not mean that it should not be examined.

It is most important that we not make the mistake that has been made with ventilations, endotracheal tubes, extraglottic airways, antiarrhythmic drugs, pressor drugs, anti-acidosis drugs, antidote drugs, anti-hypoglycemic drugs, et cetera. We should insist that there be valid evidence of some sort of benefit before the ACLS (Advanced Cardiac Life Support) Committee of Failed Treatments adds this to the ACLS algorithms because of an abundance of wishful thinking.
 

This time will be different.
 

This use of ketamine is interesting. Ketamine is a sedative that should not depress vital signs, so it may do what we expect. There may be more benefit than harm, but there may be more harm than benefit, or there may be all harm and no benefit. We will not know until we have valid research.

We have added the other treatments without finding out if they improve outcomes. We continue to remove these treatments as we obtain evidence, because they have one thing in common – they don’t improve outcomes.

These treatments have increased the ignorance of those who work in EMS (Emergency Medical Services) and EM (Emergency Medicine). We keep convincing ourselves that we know what we are doing, but evidence keeps showing that we are lying to ourselves.

Maybe ketamine sedation during compressions will be beneficial. It is such a small patient population, that it will be difficult to study. Introducing a treatment without studying it will always be a mistake. Is Nebraska studying this? Probably, but it is not stated in the paper. Has this been approved by an IRB (Institutional Review Board)? I do not know.

Footnotes:

[1] CPR induced consciousness: It’s time for sedation protocols for this growing population
Rice, D., Nudell, N., Habrat, D., Smith, J., & Ernest, E. (2016). Resuscitation DOI: 10.1016/j.resuscitation.2016.02.013
Free Full Text from Resuscitation.

[2] Return of consciousness during ongoing cardiopulmonary resuscitation: A systematic review.
Olaussen A, Shepherd M, Nehme Z, Smith K, Bernard S, Mitra B.
Resuscitation. 2015 Jan;86:44-8. doi: 10.1016/j.resuscitation.2014.10.017. Epub 2014 Nov 4. Review.
PMID: 25447435

[3] Anxiety and depression among out-of-hospital cardiac arrest survivors.
Lilja G, Nilsson G, Nielsen N, Friberg H, Hassager C, Koopmans M, Kuiper M, Martini A, Mellinghoff J, Pelosi P, Wanscher M, Wise MP, Östman I, Cronberg T.
Resuscitation. 2015 Dec;97:68-75. doi: 10.1016/j.resuscitation.2015.09.389. Epub 2015 Oct 9.
PMID: 26433116

Rice, D., Nudell, N., Habrat, D., Smith, J., & Ernest, E. (2016). CPR induced consciousness: It’s time for sedation protocols for this growing population Resuscitation DOI: 10.1016/j.resuscitation.2016.02.013

Olaussen A, Shepherd M, Nehme Z, Smith K, Bernard S, & Mitra B (2015). Return of consciousness during ongoing cardiopulmonary resuscitation: A systematic review. Resuscitation, 86, 44-8 PMID: 25447435

Lilja G, Nilsson G, Nielsen N, Friberg H, Hassager C, Koopmans M, Kuiper M, Martini A, Mellinghoff J, Pelosi P, Wanscher M, Wise MP, Östman I, & Cronberg T (2015). Anxiety and depression among out-of-hospital cardiac arrest survivors. Resuscitation, 97, 68-75 PMID: 26433116

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