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

- Rogue Medic

Intranasal midazolam vs rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy – Part 1


ResearchBlogging.org
Also posted over at Paramedicine 101 (now at EMS Blogs) and at Research Blogging. Go check out the excellent material at these sites.

Yesterday I wrote about the law being signed to allow teachers to give rectal diazepam (Valium) to student (for seizures, not to keep the class quiet).[1] Today I look at some of the reasons to question the use of RD (Rectal Diazepam) Diastat from Valeant Pharmaceuticals North America.

SEIZURES ARE THE MOST COMMON medical problem requiring emergency medical services (EMS) transport in pediatric patients, accounting for up to 25% of all pediatric EMS calls in the United States.1 [2]

This is certainly not an unimportant topic. IV (IntraVenous) lines may not be easy in children and are even more difficult during active seizures, so what is the best alternative? IO (Intraosseous) during a seizure? PR (Per Rectum) during a seizure? IN during a seizure?

On the other hand . . .

Most seizures stop within 5 minutes and do not mandate immediate medical treatment.3[2]

Maybe a more conservative approach is indicated and treatment is only indicated for active seizures.[3]

However, avoiding treatment is not always the right thing to do and can result in crippling or deadly outcomes.

Seizures that last longer than 5 to 10 minutes, however, are unlikely to stop without treatment and become more difficult to control with time.3 Prolonged or recurrent seizure activity persisting for 30 minutes may result in significant morbidity and mortality that correlates directly with seizure duration.3 [2]

Therefore, some treatment option is essential. An IV is not always possible, or even practical. An IO is also not always possible or practical. Since the lack of treatment may result in permanent disability or death, what options are available and what works best?

The cost of IN midazolam is $12 per dose.11 [2]

In the United States, the cost of RD (Diastat) is roughly $212 per dose.11 [2]

For parents, it is probably cheaper to call an ambulance than to buy the RD (Rectal Diazepam) Diastat. There is usually no charge for treatment without transport. The concern is about stopping seizures and/or preventing further seizures. EMS is great at that.

Just based on money and the less socially awkward method of administration, unless PR diazepam significantly improves outcomes, the choice is simple for anyone who has to pay for Diastat.

Don’t!

Why pay over 17 times as much for the same outcome?

The burden of proof is clearly on those who would claim that PR diazepam is in any way better.

Diazepam has been around since 1963, so there should be a cheap generic version available. For EMS, there is a cheap generic version. For parents, there is the very expensive Diastat.


Image credit.[4]

In EMS, we just take the 14 gauge catheter off of the needle and put it on a syringe that already has diazepam drawn up in it, lubricate the catheter liberally, insert it a couple of inches into the rectum, slowly pushing the plunger over a few seconds, waiting a few seconds, and removing the catheter while holding the buttocks together. Do not ever duct tape the patients buttocks together.

Complicated? Not really, especially after doing this once. More effective?

No.

One affordable alternative to this multi-hundred dollar drug administration is –

The Mucosal Atomization Device (Wolf Tory Medical Inc, Salt Lake City, Utah) is an applicator placed on the syringe hub that distributes liquid for nasal administration in a 30-μ particle size, coating the mucosa.33 It is relatively inexpensive at $4 per applicator.11 [2]


Image credit.[5]

Added 18:00 10/09/2011 –

The project was registered with ClinicalTrials.gov. This research project was not sponsored or funded by a company. There is no relationship between the authors and the development, evaluation, and promotion of the IN-MMAD.[2]

In Part 2 I will look at the results of this study. Is IN midazolam as effective as rectal Diastat?

Footnotes:

[1] Teachers to Give Rectal Valium in California
Rogue Medic
Article

[2] Intranasal midazolam vs rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy.
Holsti M, Dudley N, Schunk J, Adelgais K, Greenberg R, Olsen C, Healy A, Firth S, Filloux F.
Arch Pediatr Adolesc Med. 2010 Aug;164(8):747-53.
PMID: 20679166 [PubMed – indexed for MEDLINE]

Free Full Text at Arch Pediatr Adolesc Med

[3] Management of prehospital seizure patients by paramedics
Rogue Medic
Article

[4] Dosing and Administration of DIASTAT® AcuDial™ (diazepam rectal gel)
Diastat.com
Valeant Pharmaceuticals North America
Information page with link to PDF download of administration instructions

[5] Therapeutic Intranasal Drug Delivery
IntraNasal.net
Article

Holsti M, Dudley N, Schunk J, Adelgais K, Greenberg R, Olsen C, Healy A, Firth S, & Filloux F (2010). Intranasal midazolam vs rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy. Archives of pediatrics & adolescent medicine, 164 (8), 747-53 PMID: 20679166

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Comments

  1. Intramuscular Midazolam, quick, cheap, easy.

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