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

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

.

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

.

The Magical Nonsense of Friday the 13th

ResearchBlogging.org
 

Today we celebrate the fears of those who do not understand that magic does not affect reality. Our fears of magic can affect reality, when we act on those fears. Why should a special day cause more problems than a boring day? Many people believe in magic powers as being more than just the fictional entertainment we see in novels and movies.

Here is another study of the effects of Friday the 13th on emergency medicine/EMS that I have not written about. It is no surprise that they did not find what is not there – an influence of this magic date on the type or volume of patients in the emergency department.
 

CONCLUSIONS:
Although the fear of Friday the 13th may exist, there is no worry that an increase in volume occurs on Friday the 13th compared with the other days studies. Of 13 different conditions evaluated, only penetrating traumas were seen more often on Friday the 13th. For those providers who work in the ED, working on Friday the 13th should not be any different than any other day.
[1]

 

When measuring of a large number of variables, it is expected that one, or more, will appear to be statistically significant. This is why the p value of outcomes should be adjusted when there are multiple outcomes being measured. The p value is just a measure of how likely it is that the result occurred by chance (and thus meaningless), so the more chances, the more likely that the meaningless is considered significant.
 

Fear of Friday the 13th is mistakenly attributing some magical power to a day, to a number, to the calendar, and/or to some other variation of belief in the magic of numbers.

Numbers are important and can provide us with useful information about the risks in our lives. The risks we take confidently, cautiously, or those we don’t take. Often our decisions about risk are based on faulty information, such as the fear of a date. Mathematical literacy is necessary to understand the ways that we can use numbers to obtain valid information. John Allen Paulos created the term innumeracy to describe our lack of literacy in the language of numbers. He explained this in 1988 in his book Innumeracy: Mathematical Illiteracy and its Consequences.[2]
 

Innumeracy cover
 


 

Oh! But what about Lies, damned lies, and statistics?

Doesn’t using math make it easier for people to lie to us?

No. Ignorance of math makes it easier for people to lie to us with math.

People do not often lie with numbers. People lie with words. Maybe they lie with the salesman smile. Maybe they lie with the fear monger frown. Maybe they lie unintentionally, because they don’t know what they are talking about. They lie with words. Our ignorance of logic, not our understanding of math, is what allows us to fall victim to most lies.

Today is another Friday that is no more exciting than any other Friday.

Luck works in our favor when we are prepared for the results of our actions, but that is not the kind of luck many people want to understand.
 

Happy Friday the 13th – New and Improved with Space Debris – Fri, 13 Nov 2015

Friday the 13th and full-moon – the ‘worst case scenario’ or only superstition? – Fri, 13 Jun 2014

Blue Moon 2012 – Except parts of Oceanea – Fri, 31 Aug 2012

2009’s Top Threat To Science In Medicine – Fri, 01 Jan 2010

T G I Friday the 13th – Fri, 13 Nov 2009

Happy Equinox! – Thu, 20 Mar 2008

Footnotes:

[1] Answering the myth: use of emergency services on Friday the 13th.
Lo BM, Visintainer CM, Best HA, Beydoun HA.
Am J Emerg Med. 2012 Jul;30(6):886-9. doi: 10.1016/j.ajem.2011.06.008. Epub 2011 Aug 19.
PMID: 21855260

[2] Innumeracy: Mathematical Illiteracy and its Consequences
Wikipedia
Page on Wikipedia

.

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

.

Ketamine For Anger Management

 

I have been meaning to write about this ketamine study, but Greg Friese wrote about one of the comments on a review of the paper –
 

Most intriguing is this reader comment “talk to your damn patients calm them down and you can avoid this knee jerk, sedate first ask questions later whilst risking side effects, response ,that seems to be coming the norm” which seems disconnected to the actual syndrome of ExDS and the danger to medics, cops, and the patient when a patient’s behavior is out of control.[1]

 

Intriguing?
 

Tasmanian Devil - from outbackcooking dot blogspot dot com 1
 

The review was by Dr. Ryan Radecki of Emergency Medicine Literature of Note (the best quick and to the point reviews of research I know of on line). Did Dr. Radecki even suggest that we should avoid attempts at talking the patient down?
 

From the land of “we still have droperidol”, this case series details the use of ketamine as “rescue” treatment for “agitated delirium”. In lay terms, the situation they’re describing is the utterly bonkers patient being physically restrained by law enforcement for whom nothing else has worked.[2]

 

No.

Did the authors of the original paper suggest that we should avoid attempts at talking the patient down (verbal de-escalation)?
 

The sedation of agitated and aggressive patients in the emergency department (ED) and other acute care areas is a major problem for health care workers. Patients with acute behavioral disturbance may respond to verbal de-escalation or oral sedation, but a substantial proportion of this group requires parenteral sedation and mechanical restraint.1, 2, 3, 4, 5 [3]

 

No.

What about the studies cited above?

This is from one –
 

Combined pharmacological sedation and physical restraint were required on 66 (46%) occasions, pharmacological sedation alone on 20 (14%), physical restraint alone on 14 (10%) and neither on 43 (30%) occasions.[4]

 

30% of patients did not require physical and/or chemical restraint.

What does require mean?

How many patients can be managed by just talking them down? Should we avoid preparation for chemical and physical restraints, just because we are trying to talk the patient down?
 

There is indirect evidence from pharmacologic studies of agitation that verbal techniques can be successful in a substantial percentage of patients. In a recent study, patients were excluded from a clinical trial of droperidol if they were successfully managed with verbal de-escalation; however, the specific verbal de-escalation techniques were not identified or studied.12 [5]

 

Research on chemical management of excited delirium should not be interpreted as discouraging us from talking patients down.
 

Clinicians who work in acute care settings must be good multitaskers and tolerate rapidly changing patient priorities. In this environment, tolerating and even enjoying dealing with agitated patients takes a certain temperament, and all clinicians are encouraged to assess their temperament for this work.[5]

 

There is a lot of good information in the article, but approaching every patient with the expectation that verbal de-escalation will work is unrealistic. A lack of preparation sets everyone up for a worse outcome in the cases where verbal de-escalation does not work. Injuries and death become more likely, when we are not prepared to switch to sedation and have only physical restraint to respond to rapidly changing patient priorities.

We need to be able to adapt to the agitated patient. Verbal de-escalation and excited delirium do not get enough attention. This paper does not address the use of verbal de-escalation, because the enrolled patients had to fail to respond to other chemical sedation first. The patients who failed chemical sedation are also the ones who failed to respond to whatever attempts at verbal de-escalation were used.
 

Read the full paper on verbal de-escalation.

Footnotes:

[1] Sunday morning reader – coffee, ketamine, and EMS news
Everyday EMS Tips
by Greg Friese
March 6, 2016
Article

[2] Ketamine For Anger Management
Emergency Medicine Literature of Note
Friday, March 4, 2016
Posted by Ryan Radecki
Article

[3] Ketamine as Rescue Treatment for Difficult-to-Sedate Severe Acute Behavioral Disturbance in the Emergency Department.
Isbister GK, Calver LA, Downes MA, Page CB.
Ann Emerg Med. 2016 Feb 10. pii: S0196-0644(15)01562-0. doi: 10.1016/j.annemergmed.2015.11.028. [Epub ahead of print]
PMID: 26899459

[4] Structured team approach to the agitated patient in the emergency department.
Downes MA, Healy P, Page CB, Bryant JL, Isbister GK.
Emerg Med Australas. 2009 Jun;21(3):196-202. doi: 10.1111/j.1742-6723.2009.01182.x.
PMID: 19527279

[5] Verbal De-escalation of the Agitated Patient: Consensus Statement of the American Association for Emergency Psychiatry Project BETA De-escalation Workgroup.
Richmond JS, Berlin JS, Fishkind AB, Holloman GH Jr, Zeller SL, Wilson MP, Rifai MA, Ng AT.
West J Emerg Med. 2012 Feb;13(1):17-25. doi: 10.5811/westjem.2011.9.6864.
PMID: 22461917

Free Full Text from PubMed Central.

.

The Second EMS What-if-We’re-Wrong-a-Thon

 

Brandon Oto promoted The First EMS What-if-We’re-Wrong-a-Thon last year, but I was taking a break from blogging at the time, so I did not participate. The idea is to consider a position from the perspective of being wrong.

This is the way science works. An idea (hypothesis) is tested by attempting to prove that it is wrong, rather than attempting to prove that it is true. Unfortunately, not all science is done well. Ideology (politics, religion, nationalism, stereotyping, . . . ) is the opposite of science. The goal of ideologues is to defend the dogma, rather than to find the truth.

Since valid evidence to the contrary is all that I need to change my mind, as I have on ventilation in cardiac arrest, high flow oxygen for just about anything, epinephrine any drug for cardiac arrest, intubation as the gold standard of airway management, et cetera, is to look at something based more on opinion, rather than evidence.
 

What have I been wrong about that I have not yet corrected in writing? Romazicon (flumazenil) is a benzodiazepine antagonist which has the nasty side effect of producing seizures. I have condemned the suggestion that it should be used by EMS, because it is just an ALS (Advanced Life Support) means of trying to correct a BLS (Basic Life Support) problem with the potential for creating ALS problems that would result in even more ALS solutions.[1]
 

In considering the effects of flumazenil, have I put too much emphasis on the adverse effects and not enough emphasis on the ways that the side effects can be prevented or managed?
 

Putting much more emphasis on the side effects, rather than on the benefits is important in pharmacology, because the benefits are usually less than we expect and the serious side effects should be much less frequent than the benefits. If the serious side effects are not much less frequent than the benefits, why use the drug?

The importance of large studies is less in quantifying the benefits, but in having enough data to identify the side effects. The second most famous example of this is the Cardiac Arrhythmia Suppression Trial,[2] which was intended to show which brand of antiarrhythmic drug saved the most lives. The one that saves the most lives is clearly the best and would be marketed aggressively as the best. The result was to demonstrate that the antiarrhythmic drugs were killing people. About 60,000 people, who would not have died at that time, were killed by these drugs. These drugs were the most frequently prescribed drugs in America at that time. All of the best doctors knew that the drugs improved survival – except the drugs were killing patients.

The most famous example of a small rate of serious side effects not being identified until a lot of people were affected is thalidomide.[3] This produced dramatic deformities in the children of mothers who had taken thalidomide for nausea and vomiting of pregnancy. Since the ideas of pure good and pure evil are ideological, rather than real, there are appropriate uses for thalidomide in the treatment of Hansen’s disease (leprosy) and multiple myeloma. Good medicine requires that we balance the benefits and risks in order to increase the probability of an improvement in outcome.
 

What if, in the case of flumazenil, the side effects are both known and manageable?
 
midazolam plus flumazenil = safer qm 2
 

Flumazenil is not as dangerous as I initially thought. I was giving too much emphasis to the problems. I also think that a reasonable case can be made that we should use benzodiazepines more aggressively, while managing airway compromise and oversedation with flumazenil as an occasional supplement to BLS methods such as proper positioning to maintain the airway and stimuli to promote respiratory drive. An IM (IntraMuscular) dose of 10 mg of midazolam (Versed) may be a good starting dose for a small or medium-sized person.

What about seizures? Seizures do occur, but they are not common. Flumazenil is a competitive antagonist, so more benzodiazepine can be given to stop a seizure, but we should not be getting anywhere near that complication. Seizures are not common and only one of the uses of benzodiazepines is to stop seizure activity. There is no good reason to expect seizure activity if we are giving tiny doses (smaller than the recommend doses of flumazenil) to patients who are being sedated with benzodiazepines (the wrong drugs, but often the only ones available to EMS) for agitated delirium and happen to become so sedated that a bad outcome is likely without intervention.[4]

The current issue of the British Journal of Clinical Pharmacology has the theme of the appropriate use of antidotes.
 

Themed issue Antidotes in Clinical Toxicology

Theophrastus Bombastus Paracelsus von Hohenheim (1493–1541) said it all with Dosis sola facit venenum or in modern language “It is the dose, stupid”. So, for a journal of Clinical Pharmacology that as a matter of principle deals with the relation between dose and effect, covering the high end of de (the?) dose – effect relationship is nothing out of the ordinary. This issue is largely about how to treat unfortunate patients who have reached the dark side of the dose–response curve. This can be done by antidotes.[5]

 

This can be done by antidotes.     Not – This must be done by antidotes.

It is the dose, stupid, is usually translated as The dose makes the poison, or –
 

All things are poison and nothing is without poison, only the dose permits something not to be poisonous. – Paracelsus.
 

Only one article in this issue addresses flumazenil, and that is only as part of a general discussion of antidotes (which also mentions the use of benzodiazepines as the antidote for overdose of amphetamines and other stimulants and for drug induced delirium). The article does encourage caution in the use of flumazenil –
 

For other antidotes, a clinical effect is pharmacologically expected, obvious and rapid (e.g. reversal of coma with flumazenil or naloxone, or resolution of delirium with physostigmine). However, this does not necessarily translate into improved clinical outcomes over supportive care [2]. [6]

 

What if the important safety criteria are using small doses, repeated reassessment, and critical judgment?

Can EMS do that? Our failures with airway management (it is still popular to claim that no evidence of benefit or safety is needed, in spite of the many studies showing harm from intubation) suggest that we cannot, but people keep pointing out that I am an optimist. I think that education can reach many of the dogmatic deniers of science and promoters of emotion over reality.

The use of tiny doses of naloxone (Narcan) to increase the respiratory drive, but not the alertness, of patients with opioid overdoses may result in a sudden increase in level of consciousness and aggression, but that is not typical.

Can we produce better outcomes with judicious use of antidotes in addition to supportive care as a way of managing aggressive use of benzodiazepines? Maybe, but it is not something people seem to want to study. We have given the drug to be reversed and know the dose we gave, so we are not dealing with an unknown overdose. The patient may have ingested other drugs that are unknown, but they tend to be stimulants, which is why we are giving a sedative. The patient may even have taken a benzodiazepine at some point, but more benzodiazepine is not a reason to avoid flumazenil.

The better question is can we improve outcomes for violent patients and for the people who deal with violent patients, with more aggressive use of benzodiazepines and judicious use of flumazenil to minimize the side effects of aggressive benzodiazepine use?

Benzodizepines are the wrong drugs to use for agitated delirium, unless combined with more effective medication. Some EMS providers do not have access to the most effective sedatives, or even the second most effective sedatives. I am limited to benzodiazepines and only in doses that are too low. Adding flumazenil to my scope of practice might help the medical directors to provide better EMS education and more aggressive standing orders.

There is more to write about flumazenil, but this is plenty for today.
 

Also writing in The Second EMS What-if-We’re-Wrong-a-Thon are –

Michael Morse (Rescuing Providence) — asks… what if community paramedicine really is the future of EMS?

Dale Loberger (High Performance EMS) — asks… what if emergency response times don’t really matter all that much?

Amy Eisenhauer (The EMS Siren) — wonders… whether the role of social media in EMS is such a good thing after all.

Ginger Locke — asks… what if video laryngoscopy really is the best first-pass technique for routine endotracheal intubation?

Footnotes:

[1] Flumazenil and EMS – A Box Pandora Should Not Open
Fri, 20 Mar 2009
by Rogue Medic
Article

[2] Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial.
Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, Arensberg D, Baker A, Friedman L, Greene HL, et al.

N Engl J Med. 1991 Mar 21;324(12):781-8.
PMID: 1900101 [PubMed – indexed for MEDLINE]

Free Full Text from NEJM.

CONCLUSIONS. There was an excess of deaths due to arrhythmia and deaths due to shock after acute recurrent myocardial infarction in patients treated with encainide or flecainide. Nonlethal events, however, were equally distributed between the active-drug and placebo groups. The mechanisms underlying the excess mortality during treatment with encainide or flecainide remain unknown.

I have written about this in C A S T and Narrative Fallacy and elsewhere.

[3] Thalidomide: the tragedy of birth defects and the effective treatment of disease.
Kim JH, Scialli AR.
Toxicol Sci. 2011 Jul;122(1):1-6. doi: 10.1093/toxsci/kfr088. Epub 2011 Apr 19. Erratum in: Toxicol Sci. 2012 Feb;125(2):613.
PMID: 21507989

Free Full Text from Toxicol Sci.

[4] Excited Delirium: Episode 72 EMS EduCast
Wed, 29 Sep 2010
by Rogue Medic
Article

[5] Issue highlights
British Journal of Clinical Pharmacology
Special Issue: Antidotes in Clinical Toxicology
Volume 81, Issue 3, pages 398–399, March 2016
DOI: 10.1111/bcp.12909
Article

[6] Who gets antidotes? choosing the chosen few.
Buckley NA, Dawson AH, Juurlink DN, Isbister GK.
Br J Clin Pharmacol. 2016 Mar;81(3):402-7. doi: 10.1111/bcp.12894. Epub 2016 Feb 17. Review.
PMID: 26816206

Free Full Text from Br J Clin Pharmacol.

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Deadpool – maybe it only hurts when you laugh, but you laugh anyway

 

What if you took an extremely sarcastic person and made him a god? You could have a triple R rated success.

Horace Walpole has a great quote, that seems to baffle the sanctimonious –

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

Jonathan Swift and Lewis Carroll might regret that this movie only skims the surface in its satire, but they had to use satire to avoid prosecution for blasphemy, heresy, and other thought crimes that are trying for a comeback.

Marvel vs. DC. iPhone vs. Android. Fire vs. private vs. hospital. Little-Endian vs. Big-Endian and High Heels vs. Low Heels.[1] Mine is the One True WhateverTM.
 

Deadpool kneel before Zod sign 1a
Best still of Deadpool at Comic Con

 


 

Election season is the perfect time for Deadpool to be in theaters, because the preachers, pundits, and politicians are more absurd and obscene than anything in the movie.
 

Satire is a sort of glass wherein beholders do generally discover everybody’s face but their own; which is the chief reason for that kind reception it meets with in the world, and that so very few are offended with it.[2]

 

Deadpool doesn’t even try to fit the right wing or left wing politically correct model. The preachers, pundits, and politicians claim that the greater obscenities they promote are virtues. Perhaps they are so ridiculous, they no longer need others to ridicule them.

 

Alice laughed. “There’s no use trying,” she said: “one can’t believe impossible things.”

“I daresay you haven’t had much practice,” said the Queen. “When I was your age, I always did it for half-an-hour a day. Why, sometimes I’ve believed as many as six impossible things before breakfast.”[3]

 
 

We should soon see an honest emulation among the married women, which of them could bring the fattest child to the market. Men would become as fond of their wives, during the time of their pregnancy, as they are now of their mares in foal, their cows in calf, or sow when they are ready to farrow; nor offer to beat or kick them (as is too frequent a practice) for fear of a miscarriage.[4]

 

If you work in a medical field, you should have seen enough misery to have an appreciation of a dark sense of humor and an understanding of the fraud of treating others as less deserving because they are in some way different.

A world of collateral damage is a comedy. Some of us keep going for the even bigger laugh of the bigger body count.

A world of starvation is a comedy. Some of us oppose using GMOs (Genetically Modified Organisms) to prevent the even bigger laugh of the bigger body count.

A world of death by preventable illness is a comedy. Some of us oppose using vaccines to prevent the even bigger laugh of the bigger body count.

The truly twisted sense of humor is not the obscenity in this movie, but the sanctimony of those encouraging killing, in the name of whatever, while claiming to be good.

Footnotes:

[1] Part I, Chapter IV
Mildendo, the metropolis of Lilliput, described, together with the emperor’s palace. A conversation between the author and a principal secretary, concerning the affairs of that empire. The author’s offers to serve the emperor in his wars.
Gulliver’s Travels into Several Remote Nations of the World (1726)
Jonathan Swift
eBooks@Adelaide
The University of Adelaide Library
University of Adelaide
South Australia 5005
Chapter IV
 

For,” said he, “as flourishing a condition as we may appear to be in to foreigners, we labour under two mighty evils: a violent faction at home, and the danger of an invasion, by a most potent enemy, from abroad.

 

[2] The Preface of the Author
A Full and True Account of the Battle Fought Last Friday Between the Ancient and the Modern Books in Saint James’s Library. (1704)
Jonathan Swift
The Literature Network
Introduction

[3] Chapter 5: Wool and Water
Through the Looking-Glass, and What Alice Found There (1871)
Lewis Carroll (Charles Lutwidge Dodgson)
eBooks@Adelaide
The University of Adelaide Library
University of Adelaide
South Australia 5005
Chapter 5

[4] A Modest Proposal for preventing the children of poor people in Ireland, from being a burden on their parents or country, and for making them beneficial to the publick (1729)
Jonathan Swift
eBooks@Adelaide
The University of Adelaide Library
University of Adelaide
South Australia 5005
Full Text

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Should Universities Avoid Sensitive Topics Because of Guns in the Classroom?

 

There is paranoia over having guns on campus at state schools in Texas, but where is the evidence to support the fear that armed students will suddenly resort to violent disagreement? Professors are being encouraged to avoid sensitive topics if there are armed students in the classroom. Has discussion of sensitive topics previously resulted in attacks on professors with knives, clubs, chairs, or fists?
 

With students potentially carrying weapons after Aug. 1, University of Houston faculty members may want to avoid sensitive subjects or drop certain topics from their curriculum altogether, a forum of professors suggested recently.

A slide shown at a recent discussion of a new state law, which will allow licensed individuals to carry concealed handguns on campus, says faculty may want to “not ‘go there’ ” to avoid creating a tense situation. This echoes concerns voiced by professors across the state that allowing guns into the classroom will limit academic freedoms and inhibit discussion of sometimes touchy subjects.[1]

 

We do need to know more about the causes of shootings, but Congress has prohibited studying this because the research often reflect the biases of the researchers, whether pro-gun or anti-gun. Researchers on the topic have not done a great job, but that is a reason to improve the research, not to prohibit research.

While there have been a lot of school shootings, is there anything to suggest that these shootings have had anything to do with discussions of sensitive topics?

No.

Will this change if students are allowed to carry firearms on campus?

Probably not.

Research would be nice, but Wayne LaPierre (executive vice president of the National Rifle Association) appears to be convinced that guns are the cause of all of the problems in America. He is the main opponent of research, which he seems to expect to uncover his secret. LaPierre is also the person who seems to profit the most from every mass shooting that makes the news.

News coverage of a mass shooting is a fund raiser for Wayne LaPierre and the NRA. While LaPierre fights to keep guns in the hands of criminals, most NRA members are more reasonable.
 

Pew - guns - background checks
Section 2: Opinions of Gun Owners, Non-Gun Owners[2]
 

Gun ownership is a topic that many people approach emotionally, rather than logically. People want guns for protection, even though there is no valid reason for the average person to feel safer with a gun. There are plenty of reasons to feel less safe with a gun.

The best way to protect yourself is to stay away from violent people, such as gangsters, but that is not always possible.

What is a gun supposed to protect you from? Being killed –
 

All homicides
Number of deaths: 16,121
Deaths per 100,000 population: 5.1

Firearm homicides
Number of deaths: 11,208
Deaths per 100,000 population: 3.5
[3]

 

What is the greatest risk of owning a gun?
 

All suicides
Number of deaths: 41,149
Deaths per 100,000 population: 13.0
Cause of death rank: 10

Firearm suicides
Number of deaths: 21,175
Deaths per 100,000 population: 6.7

Suffocation suicides
Number of deaths: 10,062
Deaths per 100,000 population: 3.2

Poisoning suicides
Number of deaths: 6,637
Deaths per 100,000 population: 2.1
[3]

 

People with guns are almost twice as likely to intentionally kill themselves as they are to intentionally kill someone else, so why the fear?

Then there are 505 unintentional firearms deaths, 281 firearms deaths in the undetermined category, and 467 firearms deaths in legal intervention/war category. Even the accidental (unintentional) deaths outnumber the appropriate deaths.

This does not mean that there is no good reason to own a gun. There are many, but just for the feeling of protection in a low crime area, like some who are prepared for a home invasion, is like buying a lottery ticket. Your odds of winning do not change, regardless of how many tickets you buy. Estimating the home invasion rate, since it is not usually a specific part of crime statistics, is a guess at what is just a tiny part of the violent crime rate, which has been decreasing for a quarter of a century.

Perhaps a gun is not just supposed to protect you from being killed, but from being attacked, or just from being anxious about being attacked. The suicide statistics do not suggest that guns provide an effective psychological benefit.

The NNT (Number Needed to Treat to produce a benefit) is almost impossible to measure, because of the prohibition on research and the difficulty in identifying cases where a gun might have prevented something vs. when having a gun may have contributed to a bad outcome, vs. the many other difficult to measure possible outcomes. Outcomes of even positive reports might have been better without a gun, since we generally have no way of knowing what the outcome would be if a person did not have a gun.

The NNH (Number Needed to Harm) is easier to measure. Add the accidental injuries, the accidental deaths, and the suicides and divide by the number of guns. Even this will have some difficult to measure possibilities. The difference is that the majority of this number is unambiguous, while the benefit is almost entirely speculative.

The bad outcomes are only going to be a fraction of one percent. They are like dealing with terrorism, which is like mass shootings – rare, dramatic, and emotional. We are not good at making these decisions rationally.
 

But how dangerous are guns?
 

Actual causes of death in US in 2000 - a
Actual Causes of Death[4]
 

Some of the death rates, such as due to motor vehicles and firearms, have decreased since 2000, while others, such as illicit drug use have increased.
 

Three Selected Causes of Injury†— National Vital Statistics System, United States
The full image shows more dramatic changes since 1979, but I edited it to show only the changes since 1999.[5]
 

Guns are much less dangerous than tobacco, obesity/inactivity, or alcohol, but more dangerous than terrorism. We don’t worry much about tobacco, obesity/inactivity, or alcohol, but we panic about terrorism. Risk management is not something we do well. We evolved a fight, flight, or freeze response to threats. These are reflexive and emotional responses. Universities are supposed to promote reasonable discussion of diverse and sensitive topics, but they have encouraged political groups to shout down the ideas they do not want to hear.

Professors are supposed to think clearly about things, and educate students to think clearly. Avoiding sensitive topics, because students might not be reasonable, is not reasonable.

Footnotes:

[1] UH faculty suggest steering clear of some topics if students armed
By Benjamin Wermund
Updated 8:30 am, Wednesday, February 24, 2016
Houston Chronicle
Article

[2] Section 2: Opinions of Gun Owners, Non-Gun Owners
March 12, 2013
Why Own a Gun? Protection Is Now Top Reason
Perspectives of Gun Owners, Non-Owners
Pew Research Center
Study

[3] Deaths-Final Data for 2013
Jiaquan Xu, M.D.; Sherry L. Murphy, B.S.; Kenneth D. Kochanek, M.A.; and
Brigham A. Bastian, B.S., Division of Vital Statistics
National Vital Statistics Reports
Volume 64, Number 2
February 16, 2016
Free Full Text in PDF format

[4] Actual causes of death in the United States, 2000.
Mokdad AH, Marks JS, Stroup DF, Gerberding JL.
JAMA. 2004 Mar 10;291(10):1238-45. Review. Erratum in: JAMA. 2005 Jan 19;293(3):298. JAMA. 2005 Jan 19;293(3):293-4.
PMID: 15010446

[5] QuickStats: Death Rates* for Three Selected Causes of Injury†— National Vital Statistics System, United States, 1979–2012
Morbidity and Mortality Weekly Report (MMWR)
November 21, 2014 / 63(46);1095
Edited to show only the changes since 1999
Free Full Image with footnotes from CDC.

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