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

- Rogue Medic

Benzodiazepines are often misused – Part I

 
The most commonly used benzodiazepines in EMS/EM (Emergency Medical Services/Emergency Medicine) are diazepam (Valium), lorazepam (Ativan), and midazolam (Versed). It should be relatively easy to look at the best research and determine –

1. Should benzodiazepines be the first parenteral medication given for seizures?

2. Should benzodiazepines be the first parenteral medication given for agitated delirium/excited delirium (it is a real condition that results in death in custody much more often than intentional police misbehavior)?

3. Should benzodiazepines be the first parenteral medication given for sedation?

In EMS/EM, some of the important things to consider are the time it takes for the drug to take effect, the likelihood that the drug will produce the desired effect, the seriousness of adverse effects and rate at which the most serious adverse effects occur.

Seizures

Is there any evidence that anything works quicker than IM (IntraMuscular) midazolam, when the patient does not already have an IV (IntraVenous line)?

Is there any evidence that an initial dose of 10 mg IM midazolam is too high of an initial dose for an adult (over 40 kg) or that 5 mg is too high of an initial dose for a child (40 kg or less)?

Is there any evidence that this dosing increases the rate of airway compromise above what would occur with lower doses?

The Rampart study[1] strongly suggests that 10 mg of IM midazolam is the best approach for the seizing patient who does not already have an IV, when IM midazolam is available. If midazolam is not available, such as due to poorly written protocols, midazolam is not an option and delaying less effective care to wait for the ideal treatment would be reckless.

There do not appear to be any studies that show any better outcomes with any other benzodiazepoines or with any other doses.
 

What about when an IV is already in place?

Should IV midazolam be used?

Should IV lorazepam be used?

Should IV diazepam be used?

Should some other drug be used?

The evidence is not clear, but is there any reason to believe that lorazepam, or diazepam, works as quickly as midazolam, when given intravenously?

Is there any reason to believe that lorazepam, or diazepam, produce fewer, or less serious, adverse effects than midazolam, when given IV?

I don’t know of any valid evidence to suggest that midazolam is inferior to either diazepam or lorazepam.

There is also the benefit in EMS of a much shorter time of effect for midazolam.

A drug that wears off quickly is going to be the safer EMS drug – unless there is a good reason to use a drug that lasts longer.

I will explain why wearing off quickly is important in EMS treatment of seizures in Part II (not yet posted).

Footnotes:

[1] Intramuscular versus intravenous therapy for prehospital status epilepticus.
Silbergleit R, Durkalski V, Lowenstein D, Conwit R, Pancioli A, Palesch Y, Barsan W; NETT Investigators.
N Engl J Med. 2012 Feb 16;366(7):591-600.
PMID: 22335736 [PubMed – in process]

Free Full Text from N Engl J Med.

I have written about this in Intramuscular Midazolam for Seizures – Part I,
Part II,
Part III,
Part IV,
Part V,
Part VI,
Misrepresenting Current Topics in EMS Research from EMS Expo – RAMPART,
and Images from Gathering of Eagles Presentation on RAMPART.

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Opponents of EBM Now Have More Evidence to Justify Their Rejection of Evidence


 

Those scientists clearly can’t get it right. They are constantly changing the guidelines to correct their mistakes. Why don’t they just do it right the first time.

Finally, somebody is recognizing that a treatment should only be eliminated when there is clear evidence that it harms patients – and only when we have run out of excuses to ignore the irrefutable evidence.
 

The 2015 American Heart Organization (AHO) Cardiovascular Care Guidelines will introduce three new levels of evidence in addition to the current existing levels of evidence
In addition to the current levels of evidence classes the AHO’s 2015 guidelines will include Class IVa (Anecdotal Evidence), Class V (Provider Opinion) and Class XI (Treatments Not Proven to Not Work)
[1]

 

When I was in paramedic school we were told the rules. Intubation is the most important treatment, because the airway is the most important part of patient care, because Airway begins with A, Breathing begins with B, and Circulation begins with C. A comes before B and B comes before C.

Do you think that is a coincidence? No. There’s a reason for that. We are supposed to treat the airway first – no matter what. A paramedic can only have one thought in his head at a time, so it has to be the one best thought. Airway always comes first. Did you ever try to live without an airway? Well, did you? It just doesn’t happen. The Gold Standard of Airway is intubation, so we have to intubate people or they will be dropping like flies. You don’t hear about people surviving in places where medics don’t intubate. Dead! All of ’em. Dead! It’s a fact.

This is serious business people. Every second counts, but there are a lot of seconds, so we don’t count seconds. We count minutes. So every minute counts, but only with an Airway. Without an Airway, you are dead, but you are only dead after we race your cadaver to the hospital and a doctor pronounces you dead and mutters something under his breath about us being straight out of the Dark Ages. We do respect the classics. We have to honor our roots. We can’t be eliminating traditional treatments just because they seem to harm patients.
 

AHO includes the following in the new guidelines, section IVa (Anecdotal Evidence): “Many people have seem something work or they know of someone who has seen something work, or perhaps have heard of someone who knows someone that has seem something work. If a treatment has been said to work in the past then it stands to reason that it will work again. The AHA now accepts anecdotal evidence as equivalent to and just as valid as a Class I intervention provided that the evidence is no more than 4 degrees of separation from the person.”[1]

 

They shouldn’t have left out treatments based on animal research. We have to include everything. It doesn’t matter that people do not do as well with these treatments as animals do. Don’t you love dogs and cats, or are you some kind of monster? If a treatment can bring a dog back to life then that is good enough for grandpa. If cancer can be cured in animals, but we don’t give the treatments to people we are killing people. It is a Big Pharma conspiracy to find cures and then hide them from everyone, because that is why these scientists do all of this research – so they can have the cures for themselves and watch us die. If it works in animals, there is no reason to not use it in people.

All of this research is just too expensive.

We need to just use what we know works.
 

Go read the full article.

Footnotes:

[1] Heart Organization Endorses New Level of Evidence Guildlines
Call The Cops
Posted by: RJ Beam
8/20/2014
Article

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Evidence Based Medicine and Law – Star of Life Law

This is a follow-up to the discussion of MOI (Mechanism Of Injury) begun on Ambulance Driver’s column for EMS1.com – The Cult of Mechanism, which was given a brief introduction at Ambulance Driver’s blog, then hijacked over to here for some commentary, but mainly remaining at AD’s place. Then out of nowhere it is re-hijacked by Star of Life Law. Has he no ethics about this secondary hijacking? Well, he is a lawyer.

What does this lawyer do with his post?

He writes about legal stuff. So predictable. However, a lot of the discussion was about what may land EMS in court, or our patient in the ICU/cemetery. The court room can be scary. Pete Reid writes Star of Life Law and promises to address the legal aspects of EMS on his blog. Of course he starts by picking on the guy with the big yellow head.

From the way we are quoted, it almost seems as if AD and I do not agree on the value of MOI. We do not agree on everything. For example, AD does get a bit carried away when it comes to bacon.

Neither of us seem to have much respect for the abused tool that is MOI. A tool that is held out to the EMS community as a stay out of court free card.

Will you get in trouble for basing your treatment on MOI?

If your medical director knows what the value of MOI is, then Yes. You will probably be questioned on the reason for treatments that are not based on a patient assessment.

Is there a reason to be treating a person based on what does not appear to have injured the patient?

Not really. MOI is a clue. I thought about wording this differently, so that I could write that those basing treatment on MOI don’t have a clue. That would be misrepresenting MOI. MOI is a clue about the patient’s condition, but it is a very weak clue.

What are the MOI criteria?

First let’s look at all of the ACS (American College of Surgeons) trauma triage criteria.

Physiologic criteria:
Systolic blood pressure 29 breaths/min

Anatomic criteria:
Flail chest
≥2 proximal long bone fractures
Penetrating injury (nonextremity)

“Other” criteria:
Age 55 years
Known cardiac or respiratory disease

Mechanism criteria:
Crash speed >20 mph
≥30-inch vehicle deformity
Rearward displacement of front axle
Death of a same-vehicle occupant
Ejection of patient from the vehicle
Opposite-side intrusion >24 inches
Same-side vehicle intrusion >18 inches
Vehicle rollover[1]

The funny thing about these criteria is that you cannot find them on the ACS web site. At least I cannot. I have spent hours searching the site on different occasions. Apparently these are some sort of secret.

This is all I am going to write today. There is a lot about the trauma triage criteria, their application/misapplication, and other stuff to discuss. read what others have written. Welcome Star of Life Law to the EMS blogging community.

Footnotes:

^ 1 Evidence for and impact of selective reporting of trauma triage mechanism criteria.
Burstein JL, Henry MC, Alicandro JM, McFadden K, Thode HC Jr, Hollander JE.
Acad Emerg Med. 1996 Nov;3(11):1011-5.
PMID: 8922006 [PubMed – indexed for MEDLINE]

These criteria are from a 1996 study, so they are probably not the most recent, but they do provide a lot to write about.

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Endotracheal Drug Administration in Cardiac Arrest

ET (EndotTracheal) drug administration in cardiac arrest is one resuscitation topic that refuses to die. People keep trying to bring ET drugs back to prominence in ACLS (Advanced Cardiac Life Support). In the absence of evidence of benefit of a treatment, the intervention should be studied in settings that are as controlled as possible. When the evidence suggests harm from the treatment, unless that apparent harm is outweighed by apparent benefit, the treatment probably should not even be used in controlled studies.

How does this apply to ET drug administration in cardiac arrest?

Before looking at the research, let’s look at the theory behind this.

ALS (Advanced Life Support – drugs, IVs, intubation, . . .) improves outcome from cardiac arrest.

In one recent and very large study of this, Advanced Cardiac Life Support in Out-of-Hospital Cardiac Arrest[1], the claim that ALS saves lives in cardiac arrest is shown to be not supported, at least not with the ALS that was used at the time of the study. That ALS has not changed much, but the BLS (Basic Life Support – CPR, defibrillation, . . . generally non-invasive treatments) has changed significantly.[2] There is one ALS treatment that is promising, therapeutic hypothermia,[3] but that was not being used at the time and is not the reason for this post.

The research on ALS in cardiac arrest does not show an improvement in resuscitation. Resuscitation is the ability for the patient to leave the hospital with brain function similar to the brain function they had prior to the cardiac arrest. Resuscitation is not arriving at the hospital with a pulse.

While arriving at the hospital with a pulse is important for resuscitation, focus on this is bad patient care. If we were only interested in arriving at the hospital with a pulse, we could just shock the patient into asystole, use a pacemaker and drive fast. we might have to upgrade the pacemakers from milliAmps to Amps and use thicker rubber gloves, but this could improve the number of patients arriving at the hospital with pulses. That does not mean it would improve the number of patients leaving with good brain function. A focus on pulses is not good for patient care. Even Dr. Frankenstein would feel silly yelling, It’s Alive, for a monster with just a pulse. Even the fictional doctor, in a book almost 200 years old, knew that the brain was essential to resuscitation.

If you think that arriving at the hospital with a pulse is a big deal, you probably would have done well as a banker up until this year, thinking that making reckless loans is conservative, because you wear a suit and tie. Either way, other people pay for your mistakes. With all of the increase in resuscitation rates following the improved focus on continuous good compressions, how many thousands of deaths have the get a pulse back crowd been responsible for by distracting paramedics, nurses, and doctors with ineffective and harmful drugs?

So, what research is there on ET drug administration in cardiac arrest?

One study does compare IV (Intravenous) medication administration with ET medication administration in cardiac arrest. Endotracheal drug administration during out-of-hospital resuscitation: where are the survivors?[4] There are some differences between the groups. The endotracheal drug group was 5 times larger, 5 years older, much more likely to be female, twice as likely to be in a nursing home, much less likely to have VF and much more likely to have asystole as the initial rhythm. The results still should not be ignored.

Why not?

Although this is a retrospective study with a lot of variables that have not been controlled for, it is the largest only study to look at survival to discharge.

Why does that matter?

There is no other study on ET administration worth looking at. Unless you are interested in something that looks at the change in blood level of epinephrine in a pig in a laboratory. Since I do not treat pigs in a laboratory, this is not really relevant to what I do. Even if I do find a pig in cardiac arrest under a spider web that reads, Humble, I will not be regretting that I am not more familiar with these studies. Besides the IO (IntraOsseous) needle has become standard in cardiac arrest treatment.

What were the results of the study?

Of the IV drug group, 5% survived to discharge.

That sounds typical for the resuscitation rates back then. What about the ET drug group?

Nobody survived.

If you have good circulation, you may absorb medication from the lungs without complication.

If you have circulation by way of chest compressions, that may not be the case.

If you have to stop the compressions in order to deliver the medication, you are doing more harm than any possible good that could come from providing these drugs that are not research based. Since none of the drugs are research based, apparently not even oxygen, that means all of the drugs are a problem.

There is not even evidence that providing oxygen down the ET tube is good for the patient, but we still have people who think that making Mr. Bubble in the lungs is good patient care.

Footnotes:

^ 1 N Engl J Med. 2004 Aug 12;351(7):647-56.
Comment in:N Engl J Med. 2004 Dec 9;351(24):2553-4; author reply 2553-4.
Advanced cardiac life support in out-of-hospital cardiac arrest.
Stiell IG, Wells GA, Field B, Spaite DW, Nesbitt LP, De Maio VJ, Nichol G, Cousineau D, Blackburn J, Munkley D, Luinstra-Toohey L, Campeau T, Dagnone E, Lyver M; Ontario Prehospital Advanced Life Support Study Group.
Free Full Text

One interesting aspect of the OPALS criteria is an attempt to evaluate the quality of the paramedics participating in the study. Listed among the criteria is “and paramedics had to successfully perform an endotracheal intubation in 90 percent of patients. These criteria were monitored regularly, and the three communities that failed to meet the standards were excluded.”

^ 2 Just one example of the improved resuscitation rates is provided in this post from Ambulance Driver and the comments.
Does This Mean I’m Fully Assimilated?

^ 3 Therapeutic Hypothermia
Wikipedia article

^ 4 Niemann JT, Stratton SJ, Cruz B, Lewis RJ.
Endotracheal drug administration during out-of-hospital resuscitation: where are the survivors?
Resuscitation. 2002 May;53(2):153-7.
PMID: 12009218 [PubMed – indexed for MEDLINE]

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