Kenalog for LESI

IPSIS: Formerly the Spine Intervention Society
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The story is Bristol Myers went to the FDA to request that black box warning when there was the initial controversy with patient deaths from cervical TF with Kenalog.

If the FDA went to them it would mean more to me than their corporate attorneys going to the FDA.
 
lets say you do an epidural and have a bad outcome that is completely unrelated to the steroid choice.
you go to trial. you are on the stand, and the lawyer asks you to read what the kenalog bottle says
"not for epidural use"
what is your defense?


just use depo
 
paindoc503 said:
lets say you do an epidural and have a bad outcome that is completely unrelated to the steroid choice.
you go to trial. you are on the stand, and the lawyer asks you to read what the kenalog bottle says
"not for epidural use"
what is your defense?


just use depo
Click to expand...
This
 
pmrmd said:
No expert witness could testify to any medical reason for Kenalog being unusable and DepoMedrol being “safe”.
Click to expand...
You don't want to tell a jury that another med is just as dangerous as the one you chose.

Use dexa. If it doesn't work, use depo.

Hate the game not the player.
 
pmrmd said:
No expert witness could testify to any medical reason for Kenalog being unusable and DepoMedrol being “safe”.
Click to expand...
you dont need a medical expert to testify. the plaintiff's attorney will do it.

or worse, the attorney will have the defendant read the FDA black box warning and ask "what does that mean?"
 
I may be wrong, but didn’t someone post on here a few months back that their LCD specified they had to use Kenalog?
 
So is nobody using kenalog for LESIs anymore? Is that the consensus?
 
masterPain said:
So is nobody using kenalog for LESIs anymore? Is that the consensus?
Click to expand...
I know some high volume docs that exclusively use kenalog on every single steroid case. Never a complication. I think the risk is exceedingly low. The only thing lower than the risk is the effort it takes to use depo instead of kenalog when a particulate steroid is indicated for spine.
 
Please. In this era when I can get one injection every 3 months I’m going to use dex only? When the authors stated patients tended to need more injections than compared to particulate to get the same results? How many people are headed to unnecessary surgery because the injections “didn’t work” but could very well have had a different outcome with a different injectate?
DM produces bigger aggregates than triamcinolone so I don’t want to use that stuff.
 
Cannot understand why any of you would use Kenalog in an ESI given the product labeling.

Epidurals are elective medical procedures with short term benefit (months).

They do not save lives.

It is wholly irrational to stake your career on Kenalog. Beta/Depo for particulates.
 
pmrmd said:
I use it for every IL and lumbar TF I do.

In 20 or so of my patients who had TF with Kenalog/dex and then later I did the TF with dex only, no one did as well. No one.

Small n but enough for me.
Click to expand...
a lawyer will have a field day with you given black box warnings
 
Lawyers. The reason for the black box. Maybe someone could subpoena any of you to tell a jury why you use Depomedrol instead. Any medical reason or just because some lawyers made medical decisions for you?
 
Good discussion folks. Thank you. I have used a ton of every steroid mentioned and feel I get more time with kenalog vs depo. (Used depo almost exclusively for 4 years).

I only use kenalog on CESI/TESI/LESI (for spine) and have done thousands without complications. Would hate to choose to not use it only bc of technicality with FDA but then again don’t want to get smoked in court.
 
is it really that hard to use depo instead of kenalog? genuinely curious why this is even a discussion.
 
pmrmd said:
Lawyers. The reason for the black box. Maybe someone could subpoena any of you to tell a jury why you use Depomedrol instead. Any medical reason or just because some lawyers made medical decisions for you?
Click to expand...
there were more case reports of catastrophies with kenalog than depomedrol.

it may cause more and larger aggregates:
pubmed.ncbi.nlm.nih.gov

Aggregation properties of triamcinolone acetonide injection in human serum: considerations when performing epidural steroid injections - PubMed

Fewer large triamcinolone aggregates were noted in the presence of serum when compared to the non-serum control groups. However, when compared to previously studied particulate steroids, it had the largest aggregates when added to serum.
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov
that means it clumps more.

a study that looked at 4 different steroids:
pubmed.ncbi.nlm.nih.gov

Size and aggregation of corticosteroids used for epidural injections - PubMed

Compared with the particulate steroid solutions, dexamethasone sodium phosphate had particles that were significantly smaller than red blood cells, had the least tendency to aggregation, and had the lowest density. These characteristics should significantly reduce the risk of embolic infarcts or...
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov


on whether particulates are better or not:

meta-analysis no difference:
pubmed.ncbi.nlm.nih.gov

triamcinolone epidural - Search Results - PubMed

triamcinolone epidural - Search Results - PubMed
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov

no difference:
pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of lumbar transforaminal epidural steroid injections with particulate versus nonparticulate corticosteroids for lumbar radicular pain due to intervertebral disc herniation: a prospective, randomized, double-blind trial - Pub

Transforaminal epidural corticosteroid injections are an effective treatment for acute radicular pain due to disc herniation, and frequently only require 1 or 2 injections for symptomatic relief. Dexamethasone appears to possess reasonably similar effectiveness when compared with triamcinolone...
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov

Comparison of pain score reduction using triamcinolone vs. dexamethasone in cervical transforaminal epidural steroid injections - PubMed

The mean reduction in pain score in this set of 441 patients with cervical radiculopathy treated with transforaminal epidural steroid injections was independent of the type of corticosteroid formulation used. Triamcinolone (40 mg) and dexamethasone (15 mg) produced similar benefits as measured...
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov

there is better relief with triamcinolone:
pubmed.ncbi.nlm.nih.gov

Pain reduction after lumbar epidural injections using particulate versus non-particulate steroids: intensity of the baseline pain matters - PubMed

• Triamcinolone is superior to dexamethasone for epidural treatment of severe lumbar radiculopathy. • For mild to moderate pain, dexamethasone could be equally effective. • Dexamethasone reduces pain caused by disc herniation much better than it does to pain caused by fixed stenotic spinal lesions.
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov
 
If you have a complication/bad outcome it doesn’t matter which steroid you used. Only difference is the lawyer will bill less hours and have an easier job if you used kenalog. You’re screwed either way, even if you did nothing wrong.
 
MD87 said:
If you have a complication/bad outcome it doesn’t matter which steroid you used. Only difference is the lawyer will bill less hours and have an easier job if you used kenalog. You’re screwed either way, even if you did nothing wrong.
Click to expand...
If you use Kenalog anywhere in the spine, or if you use any particulate in a TFESI you’re screwed.

Otherwise you are defensible.
 
MitchLevi said:
If you use Kenalog anywhere in the spine, or if you use any particulate in a TFESI you’re screwed.

Otherwise you are defensible.
Click to expand...

In theory, you’re right. Practically speaking, I think you’re screwed no matter what. I dont use particulate for TFESI, but per the 2015 guidelines, OK to use for lumbar if dex fails.
 
MD87 said:
In theory, you’re right. Practically speaking, I think you’re screwed no matter what. I dont use particulate for TFESI, but per the 2015 guidelines, OK to use for lumbar if dex fails.
Click to expand...
Unless you use Kenalog, which already has a very clear warning on the product label.
 
masterPain said:
FDA states not for epidural use. I use it all the time. Anyone see any issue here?

Click to expand...
IPSIS has a Fact Finder about this: https://cdn.ymaws.com/www.ipsismed....tient_safety/2019_02_sis_dex_bestpractice.pdf
"Notably,while the FDA has placed a “black box” warning onthe use of epidural triamcinolone, there is no publishedevidence that indicates a difference in risk when usingtriamcinolone compared to other particulate steroid
Screenshot 2024-08-08 at 6.37.33 PM.png
agents."
 
Ducttape said:
there were more case reports of catastrophies with kenalog than depomedrol.

it may cause more and larger aggregates:
pubmed.ncbi.nlm.nih.gov

Aggregation properties of triamcinolone acetonide injection in human serum: considerations when performing epidural steroid injections - PubMed

Fewer large triamcinolone aggregates were noted in the presence of serum when compared to the non-serum control groups. However, when compared to previously studied particulate steroids, it had the largest aggregates when added to serum.
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov
that means it clumps more.

a study that looked at 4 different steroids:
pubmed.ncbi.nlm.nih.gov

Size and aggregation of corticosteroids used for epidural injections - PubMed

Compared with the particulate steroid solutions, dexamethasone sodium phosphate had particles that were significantly smaller than red blood cells, had the least tendency to aggregation, and had the lowest density. These characteristics should significantly reduce the risk of embolic infarcts or...
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov


on whether particulates are better or not:

meta-analysis no difference:
pubmed.ncbi.nlm.nih.gov

triamcinolone epidural - Search Results - PubMed

triamcinolone epidural - Search Results - PubMed
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov

no difference:
pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of lumbar transforaminal epidural steroid injections with particulate versus nonparticulate corticosteroids for lumbar radicular pain due to intervertebral disc herniation: a prospective, randomized, double-blind trial - Pub

Transforaminal epidural corticosteroid injections are an effective treatment for acute radicular pain due to disc herniation, and frequently only require 1 or 2 injections for symptomatic relief. Dexamethasone appears to possess reasonably similar effectiveness when compared with triamcinolone...
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov

Comparison of pain score reduction using triamcinolone vs. dexamethasone in cervical transforaminal epidural steroid injections - PubMed

The mean reduction in pain score in this set of 441 patients with cervical radiculopathy treated with transforaminal epidural steroid injections was independent of the type of corticosteroid formulation used. Triamcinolone (40 mg) and dexamethasone (15 mg) produced similar benefits as measured...
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov

there is better relief with triamcinolone:
pubmed.ncbi.nlm.nih.gov

Pain reduction after lumbar epidural injections using particulate versus non-particulate steroids: intensity of the baseline pain matters - PubMed

• Triamcinolone is superior to dexamethasone for epidural treatment of severe lumbar radiculopathy. • For mild to moderate pain, dexamethasone could be equally effective. • Dexamethasone reduces pain caused by disc herniation much better than it does to pain caused by fixed stenotic spinal lesions.
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov
Click to expand...
IPSIS Fact Finder: no published evidence indicating that triamcinolone poses bigger risk than other particulates in ILESI/caudal: https://cdn.ymaws.com/www.ipsismed....tient_safety/2019_02_sis_dex_bestpractice.pdf
 
pmrmd said:
Triamcinolone has smaller aggregates
Click to expand...
they looked at a bottle of each. assuming that the bottles were mixed well, then one can get a good idea.

from the standpoint of total aggregates, triamcinolone had more aggregates overall (241) at a 1:3 saline dilution (which is what i use) than depo 80 (174), but less than betamethasone (257) and depo 40 was 281.

from the standpoint of large particles, they give a huge range of 51-1000 and then >1000 for the upper ranges. for triamcinolone, that is 23% and 1%. for depomedrol 80, its 32% and 7% and for depomedrol 40, it is 17% and 1%, and for betamethasone, it is 3% and zero.

total large particles (those over 51):
depo 80 = 68
depo 40 =5
triam 40 = 57
beta 6 = 3


so depo 40 and beta 6 had the fewest number of large (>50) particles.


but if you want to use the med that has the fewest particles, choose dex. because there were zero.
 
Ducttape said:
they looked at a bottle of each. assuming that the bottles were mixed well, then one can get a good idea.

from the standpoint of total aggregates, triamcinolone had more aggregates overall (241) at a 1:3 saline dilution (which is what i use) than depo 80 (174), but less than betamethasone (257) and depo 40 was 281.

from the standpoint of large particles, they give a huge range of 51-1000 and then >1000 for the upper ranges. for triamcinolone, that is 23% and 1%. for depomedrol 80, its 32% and 7% and for depomedrol 40, it is 17% and 1%, and for betamethasone, it is 3% and zero.

total large particles (those over 51):
depo 80 = 68
depo 40 =5
triam 40 = 57
beta 6 = 3


so depo 40 and beta 6 had the fewest number of large (>50) particles.


but if you want to use the med that has the fewest particles, choose dex. because there were zero.
Click to expand...
In an interlaminar does the particle size really matter since vascular uptake really isn’t a concern? Clearly venous plexus/system in epidural space is prominent but no published studies have show complications with this uptake to my knowledge.
 
masterPain said:
In an interlaminar does the particle size really matter since vascular uptake really isn’t a concern? Clearly venous plexus/system in epidural space is prominent but no published studies have show complications with this uptake to my knowledge.
Click to expand...
No, and it doesn’t matter in an ILESI other than the fact there’s a direct warning on the product itself that says not to do it.

Everyone here knows it’s BS, but until that product label is removed, using Kenalog in the epidural space is simply dumb.

Why would you do it?

It’s a particulate and you’ve got two other options available to you.
 
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