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

- Rogue Medic

Giving New Meaning to Carpe Diem

 

On facebook, Jon Kuppinger describes the following situation –
 

So what made you decide to call now given your patient has been in full tonic-clonic seizures for over three hours now?

 

Maybe their washing machine was broken.
 


Image credit.
 

The response by the nurse?
 

The nurse was out and we don’t have access to any meds and it just seemed worse than it was earlier and we weren’t sure what to do about it so we decided to wait until she got back to call.

 

Paging Nurse Gilligan! Paging Nurse Gilligan!

The nurse was out for over three hours and . . . .
 

Just sit right back and you’ll hear a tale,
A tale of an endless fit
That started at a nursing home
Then went straight to $#!†.

The patient was a flailing man,
The aide had not a clue.
The patient’s brain was fried that day
In a three hour spaz, a three hour spaz.

The seizure started getting rough,
The patient quaked and tossed,
If not for the callousness of the staff,
The seizure would be stopped.
The seizure would be stopped.

 

Maybe they were engaging in a modern Tuskegee experiment.

Maybe they were using homeopathy or some other form of alternative medicine and were waiting for for the scam treatment to work.

Maybe three hours of seizure was getting boring and they thought that a few more hours of this might be life-threatening. If the patient dies, what will they do for entertainment tomorrow?

Unlike Robin Williams’ character in Dead Poets’ Society, I guess that we can be glad that they did not decide to let the patient seize the whole day. This is not what carpe diem means.

We’ve schedule you for a three hour high colonic tonic/clonic today. Ordering activities using drop down menus can cause some real problems.
 

Out of 205 patients, only 19 died in a study comparing using diazepam (Valium), lorazepam (Ativan), or placebo by EMS to treat seizures.[1]

Most of those who died were in the placebo group, even though the placebo group was only one third of the patients. Over 15% of the placebo group died during their hospitalization.

NNK = 6.4 (for untreated seizures)

NNK = Number Needed to Kill. NNH (Number Needed to Harm) is the actual term. These seizures were only untreated for about 15 minutes – not for three hours.

NNH = 3 1/3 (for untreated seizures).

Even an inadequate dose of benzodiazepine would lower the death rate. None of those received IM (IntraMuscular) medication. All received IV (IntraVenous) medication.

Half of the lorazepam group received only one 2 mg dose of lorazepam. The other half of the lorazepam group was given a second dose of 2 mg of lorazepam.

With such low doses, over 40% of the lorazepam patients were still seizing when they arrived at the ED (Emergency Department).

The FDA (Food and Drug Administration) recommends 4 mg lorazepam as the initial dose for seizures.
 

For the treatment of status epilepticus, the usual recommended dose of Lorazepam Injection is 4 mg given slowly (2 mg/min) for patients 18 years and older. If seizures cease, no additional Lorazepam Injection is required. If seizures continue or recur after a 10- to 15- minute observation period, an additional 4 mg intravenous dose may be slowly administered.[2]

 

A slightly smaller percentage of the diazepam patients were given a second 5 mg dose of diazepam, so it is not surprising that well over half were still seizing when they arrived at the ED.

A low dose means continuing seizures. My brand new protocols ignored the evidence from the recent IM midazolam (Versed) vs IV lorazepam study and have us continuing to use inadequate doses.[3]
 


 

Only 1 mg – 2 mg lorazepam?

Only 1 mg – 5 mg midazolam?

Holy Continuing Seizures, Batman!

Even the FDA recommends 4 mg.

4 mg was the initial dose in recent study that was safe, but not as effective as 10 mg IM midazolam
 

Does anyone take the adverse effects of seizures seriously?
 

After three hours of seizing, the patient might end up as brain damaged as the staff who decided not to treat him, but maybe not.

Brooks Walsh asks Although I’ve read the study before, I am only wondering now how the IRB for Alldredge 2001 thought there was “equipoise” between placebo and benzos.

Equipoise and Ethics and IRBs, Oh My! is my answer.

Footnotes:

[1] A comparison of lorazepam, diazepam, and placebo for the treatment of out-of-hospital status epilepticus.
Alldredge BK, Gelb AM, Isaacs SM, Corry MD, Allen F, Ulrich S, Gottwald MD, O’Neil N, Neuhaus JM, Segal MR, Lowenstein DH.
N Engl J Med. 2001 Aug 30;345(9):631-7. Erratum in: N Engl J Med 2001 Dec 20;345(25):1860.
PMID: 11547716 [PubMed – indexed for MEDLINE]

Free Full Text from N Engl J Med.

[2] Lorazepam (lorazepam) Injection, Solution
[Baxter Healthcare Corporation]

DailyMed
NLM
FDA label

[3] Seizure
7007– ALS – Adult/Peds
Statewide ALS Protocol
Pennsylvania
Page with link to Full Text Download of Full Protocols in PDF format.

[4] 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.
 

All adults and those children with an estimated body weight of more than 40 kg received either 10 mg of intramuscular midazolam followed by intravenous placebo or intramuscular placebo followed by 4 mg of intravenous lorazepam.

 

The relationships among benzodiazepine dose, respiratory depression, and subsequent need for endotracheal intubation are poorly characterized, but higher doses of benzodiazepines may actually reduce the number of airway interventions. Our data are consistent with the finding that endotracheal intubation is more commonly a sequela of continued seizures than it is an adverse effect of sedation from benzodiazepines.11

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Comments

  1. Although I’ve read the study before, I am only wondering now how the IRB for Alldredge 2001 thought there was “equipoise” between placebo and benzos.

    This is a great review!

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