New FDA warning

[urge]

http://www.fda.gov/Drugs/DrugSafety/ucm532356.htm

Discuss.

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[deleted162650]

So no cosmetic surgeries for toddlers and preggos. Got it. Man, I'm gonna have to start cancelling a lot more cases.

On a more serious note, maybe this will cut down on some of the not so necessary circs and other peds cases that clearly can wait.

 

[Aether2000]

So this finally explains the millennial generation. It all makes so much sense now

 

[ambiturner]

I do a lot of peds and find this pretty disappointing, especially since the evidence is so equivocal. That said, most cases we do in young kids probably outweigh whatever anesthetic risk there is (improved hearing after ear tubes, better sleep in tonsils, both which should improve learning if anything).

Cosmetic stuff is more interesting though - does it then become our duty to cancel cases if we feel the 'anesthetic risk' isn't worth the circ/mole removal? Is there liability involved?

Notably left off the list are nitrous and opioids, I might just start running those and turn down the sevo.

 

[VA Hopeful Dr]

You'll have to forgive my family doctor ignorance here, but aren't the majority of procedures on kids fairly short anyway (like the aforementioned ear tubes and tonsils) OR things that can't be postponed, like cardiac cases or emergencies like intusseception, NEC, appendix?

 

[ambiturner]

You'll have to forgive my family doctor ignorance here, but aren't the majority of procedures on kids fairly short anyway (like the aforementioned ear tubes and tonsils) OR things that can't be postponed, like cardiac cases or emergencies like intusseception, NEC, appendix?

Yes the vast majority are very short - 1-2 hours total anesthesia time or less. And the majority are medically necessary. But we also do get a lot of mole removals, circs, etc that can wait. And then there's a lot of MRIs for headaches, joint pain, etc in healthy kids that almost never show pathology.

I doubt practice will change much because concerned families have asked about this for years and I assume would already have been wary of elective cases, but we'll see. I'm assuming much of those decisions will be made in the surgeons' offices before they get to us.

 

[Mman]

But we also do get a lot of mole removals, circs, etc that can wait.

Mole removals? How young of kids are you seeing this in? I've never seen one in the OR in a patient under 10 (maybe 15 but I'm just ballparking). Melanoma is exceedingly rare in kids.

I'm just curious. I've seen a lot of weird stuff but have never come across that, let alone a lot of them.

 

[btbam]

The people who should really be worried about this are pediatric urologists...

 

[WholeLottaGame7]

We've talked about this as a division for awhile now since some of this started coming out of the SmartTots stuff. We don't really see a ton of truly elective stuff. Some of the polydactyly/skin tag stuff, some cosmetic laser procedures, some sketchy MRI orders (although most of those get prop infusions anyway).

It is a dicey subject. I don't like dropping it on families the morning of surgery unprompted because that's not really fair to freak them out over one more thing (that is still pretty fuzzy). I am happy to talk about it if they bring it up (which happens less frequently than you might think). And we don't see the vast majority of healthy outpatient kids in pre-op clinic so can't really bring it up there.

What we've kind of done is bring up the topic with the surgeons directly in out of OR meetings. Most have been pretty receptive and thoughtful about it (a few even coming to us preemptively), a minority are a little more recalcitrant.

 

[urge]

It is a dicey subject. I don't like dropping it on families the morning of surgery unprompted because that's not really fair to freak them out over one more thing (that is still pretty fuzzy). I am happy to talk about it if they bring it up (which happens less frequently than you might think). And we don't see the vast majority of healthy outpatient kids in pre-op clinic so can't really bring it up there.

That is not informed consent.

 

[BLADEMDA]

What about dental procedures under GA for little kids (age less than 3)? What if the dentists takes 3 hours per case?

 

[urge]

Yes the vast majority are very short - 1-2 hours total anesthesia time or less. And the majority are medically necessary. But we also do get a lot of mole removals, circs, etc that can wait. And then there's a lot of MRIs for headaches, joint pain, etc in healthy kids that almost never show pathology.

I doubt practice will change much because concerned families have asked about this for years and I assume would already have been wary of elective cases, but we'll see. I'm assuming much of those decisions will be made in the surgeons' offices before they get to us.

Dental cleanings, hernias, urologic reflux procedures, all sort of diagnostic test like ct, mri, endoscopies, skin hemangiomas, etc.

 

[Mman]

That is not informed consent.

why not? Informed consent does not require you listing every possible side effect or complication to a procedure, let alone ones where the evidence is a little iffy at best.

 

[urge]

sketchy MRI orders (although most of those get prop infusions anyway).

Propofol got blacklisted also.

 

[urge]

why not? Informed consent does not require you listing every possible side effect or complication to a procedure, let alone ones where the evidence is a little iffy at best.

Yikes!

I'm not even going to try to argue with you. You are far too gone.

 

[Mman]

Yikes!

I'm not even going to try to argue with you. You are far too gone.

My med mal insurer and their army of lawyers disagrees with you.

Also, I do find it amusing that stating the legal standard is "too far gone" for your taste.

 

[urge]

My med mal insurer and their army of lawyers disagrees with you.

Also, I do find it amusing that stating the legal standard is "too far gone" for your taste.

Are we supposed to believe that you already sat down with your insurer and their "army" of lawyers to hash out this new issue when the ASA, SPA or other societies haven't even had time to react to it? Right!

Plus you are giving me too much ammunition. Why do you think your insurer needs an "army of lawyers"? I would imagine they need quite a few just to deal with your screw ups.

Why would you even be so cozy with your insurer? Special needs people get more attention, did you know?

 

[drmwvr]

"All the studies in children had limitations, and it is unclear whether any negative effects seen in children’s learning or behavior were due to the drugs or to other factors, such as the underlying medical condition that led to the need for the surgery or procedure."


Yet we publish these warnings in the event that they are

 

[sigrhoillusion]

Are we supposed to believe that you already sat down with your insurer and their "army" of lawyers to hash out this new issue when the ASA, SPA or other societies haven't even had time to react to it? Right!

Plus you are giving me too much ammunition. Why do you think your insurer needs an "army of lawyers"? I would imagine they need quite a few just to deal with your screw ups.

Why would you even be so cozy with your insurer? Special needs people get more attention, did you know?

I'm not even sure informed consent really covers your ass. In the end the way they will probably get you is if you deviate from the standard of care. Even if you have a bad outcome (regardless of specifically outlining EVERY single one) as long as it was not caused by you doing something stupid or not reacting appropriately, then the chance of losing a lawsuit is probably low.

 

[urge]

I'm not even sure informed consent really covers your ass. In the end the way they will probably get you is if you deviate from the standard of care. Even if you have a bad outcome (regardless of specifically outlining EVERY single one) as long as it was not caused by you doing something stupid or not reacting appropriately, then the chance of losing a lawsuit is probably low.

I agree with your statement in general, but I don't think it applies in this scenario. What you say is true for human error related bad outcomes.

In this new scenario there can be a perfect anesthetic but a claim of a poor cognitive/developmental outcome that is being attributed in the lawsuit to the anesthetic drugs. Your fault being that you did not disclose the possibility. Had you disclosed it they would have elected not to proceed. The anesthetic followed all standards of care and there was no mistake but you did not get proper informed consent. And now "Bobby" is not doing so well in school because of your careless omission.

 

[WholeLottaGame7]

That is not informed consent.

Informed consent is a joke and you know it. Consent forms are written at the first-grade level so that patients can understand it. Yet no one in their right mind would say that a first-grader is capable of actually giving consent.

I also know you don't spend 30min getting "consent" from each of your patients every day, which is at least how long it would take to go over the myriad complications and the incidences thereof for adults, as well as answer any followup questions.

I cover things that are "common" to pediatric anesthesia and things that are specific to their procedure. Shockingly, I also don't routinely talk to mom about the risk of heart attack and stroke for her 2 year old getting ear tubes.

 

[BLADEMDA]

"All the studies in children had limitations, and it is unclear whether any negative effects seen in children’s learning or behavior were due to the drugs or to other factors, such as the underlying medical condition that led to the need for the surgery or procedure."


Yet we publish these warnings in the event that they are

It's like the FDA wants to give ammo to the lawyers: droperidol, low flow sevoflurane, etc. it's all BS without scientific merit at this point. But who says you need science to convince a jury of your peers

http://www.cnbc.com/2016/10/28/jury-awards-more-than-70-million-to-woman-in-baby-powder-lawsuit.html

 

[urge]

Informed consent is a joke and you know it. Consent forms are written at the first-grade level so that patients can understand it. Yet no one in their right mind would say that a first-grader is capable of actually giving consent.

I also know you don't spend 30min getting "consent" from each of your patients every day, which is at least how long it would take to go over the myriad complications and the incidences thereof for adults, as well as answer any followup questions.

I cover things that are "common" to pediatric anesthesia and things that are specific to their procedure. Shockingly, I also don't routinely talk to mom about the risk of heart attack and stroke for her 2 year old getting ear tubes.

Informed consent is not signing a standard paper. It is the process of explaining the patient what they are getting into in whatever language you deem more adequate.

Do I spend a lot of time going over all possible complications? Not when I feel pretty confident I can avoid them. I'm not telling the Mallampati 1 patient with huge mouth opening and solid teeth that I might dislodge a tooth. I will tell the Mallampati 3/4 with poor mouth opening and loose teeth that there is a good chance of all teeth being dislodged.

But this new issue is completely different. There is nothing you can do about it. It is totally out of our control.

 

[Mman]

Are we supposed to believe that you already sat down with your insurer and their "army" of lawyers to hash out this new issue when the ASA, SPA or other societies haven't even had time to react to it? Right!

Plus you are giving me too much ammunition. Why do you think your insurer needs an "army of lawyers"? I would imagine they need quite a few just to deal with your screw ups.

Why would you even be so cozy with your insurer? Special needs people get more attention, did you know?

No, Mag Mutual has one of their lawyers (who is also a doc) come give a lecture periodically in every area they have docs in and if you attend they take 10% off your bill for the year. It's great. You get to hear a physician that is also a malpractice defense attorney lecture (and take questions) on what he considers very relevant topics in malpractice. Last year, he spent 1 of the 2 hours talking about informed consent. It was great. 2 hours of time and I basically get paid almost $1000/hr to attend.


But no, I should listen to you that has no legal training whatsoever. You obviously know everything.


Another great topic he covered was the black box warning on drugs. Did you know that from a legal standard, that warning has no more importance than any other warning contained in the package insert for a drug? From how much attention and notice people give to it, you'd think otherwise. But to a judge and lawyer, tiny small print warnings hidden on page 37 are equally important to the almighty black box.

 

[WholeLottaGame7]

Informed consent is not signing a standard paper. It is the process of explaining the patient what they are getting into in whatever language you deem more adequate.

Do I spend a lot of time going over all possible complications? Not when I feel pretty confident I can avoid them. I'm not telling the Mallampati 1 patient with huge mouth opening and solid teeth that I might dislodge a tooth. I will tell the Mallampati 3/4 with poor mouth opening and loose teeth that there is a good chance of all teeth being dislodged.

But this new issue is completely different. There is nothing you can do about it. It is totally out of our control.

We all know informed consent is not signing a piece of paper. But since you seem mostly concerned about the medicolegal ramifications of this new development, you also must realize that the consent form is the only official document that proves you got "consent" from the patient. You could spend half an hour talking about neurocognitive development in rats, the GAS study, whatever, but at the end of the day, if your patient is doing poorly in school and you get sued (which seems highly unlikely), the family can still go back and claim that they were not "appropriately informed." Unless your anesthesia consent form is several chapters of Miller or you record all of your consent conversations and upload them into the medical record.

Honestly, this is mostly semantics and hypotheticals, and I'm just poking you to play devil's advocate. If you look at the wording of the FDA document: "Health care professionals should balance the benefits of appropriate anesthesia in young children and pregnant women against the potential risks, especially for procedures that may last longer than 3 hours or if multiple procedures are required in children under 3 years," I can't think of a single case in the last 3-ish years of doing pediatric anesthesia that would fit into that category.

Pediatric circs? Nope. Skin tag removals? Nope. MRI? Nope. Any kind of hernia, even if purely elective? Nope. Laser? Maybe, but if it's purely cosmetic and repeated. But hell, you could argue that the bullying you'd get from that giant port-wine stain might have more of a detrimental effect on your school performance than the anesthetic will. And I would definitely argue that your kid's poor diet, massive amounts of screen time, absentee/disinterested parents, poor socioeconomic situation, and ****ty public schools are going to affect a kid's academic performance far more than any anesthetic will.

I think the tougher question is, should we be doing ANY purely elective procedure for young kids, regardless of number or length, and there's basically just NO data to support that either way. But like I tell parents when they ask, I don't know if anesthesia hurts development, but it definitely doesn't HELP, so if it were my kid I'd hold off as long as reasonably possible (or search for alternate treatments).

 

[Noyac]

What about dental procedures under GA for little kids (age less than 3)? What if the dentists takes 3 hours per case?

Luckily our dentist are quick. No messing around. But I'd say 70% of our dental cases are under 3yo. I have shared this information, prior to this FDA warning, with our dental colleagues. They don't care. These cases put a lot of money in their pockets and I'm finding that most dentists are all about the money. X-rays for every visit, whiteners, cosmetic procedures, cavity repairs when there isn't a cavity. The list goes on and on. It's like they are doctors!!

 

[urge]

No, Mag Mutual has one of their lawyers (who is also a doc) come give a lecture periodically in every area they have docs in and if you attend they take 10% off your bill for the year. It's great. You get to hear a physician that is also a malpractice defense attorney lecture (and take questions) on what he considers very relevant topics in malpractice. Last year, he spent 1 of the 2 hours talking about informed consent. It was great. 2 hours of time and I basically get paid almost $1000/hr to attend.


But no, I should listen to you that has no legal training whatsoever. You obviously know everything.

That is very good. But it was last year's talk. I maintain my position that is different from all consents you have ever obtained.

 

[urge]

Honestly, this is mostly semantics and hypotheticals, and I'm just poking you to play devil's advocate. If you look at the wording of the FDA document: "Health care professionals should balance the benefits of appropriate anesthesia in young children and pregnant women against the potential risks, especially for procedures that may last longer than 3 hours or if multiple procedures are required in children under 3 years," I can't think of a single case in the last 3-ish years of doing pediatric anesthesia that would fit into that category.

You are forgetting that it also says: "Parents and caregivers should discuss with their child’s health care professional the potential adverse effects of anesthesia on brain development, as well as the appropriate timing of procedures that can be delayed without jeopardizing their child’s health."

How are they going to do that if you don't give them the information/opportunity?

 

[Noyac]

"Since the existence of anesthetic neurotoxicity in children is still unclear, conversations with parents should be undertaken with care. Given the unclear benefit of such a discussion, there does not appear to be a compelling medical argument to actively raise this concern during the anesthetic consent process. If families or clinicians have questions about anesthetic neurotoxicity, physician anesthesiologists should be prepared to answer them and participate in discussions with the perioperative team. Conversations about modifying medical care should be undertaken with particular caution, as unintended harmful consequences may result from delaying necessary surgery or changing a patient’s anesthetic management. "- This statement is from: A 2015 consensus statement about the use of anesthetics in children is available from SmartTots, a collaborative effort between the International Anesthesia Research Society, U.S. Food and Drug Administration and many others working together to make anesthesia safer for infants and children. The consensus statement has been endorsed by a wide range of anesthesia and pediatric societies including the American Society of Anesthesiologists and Society for Pediatric Anesthesia.


http://www.kevinmd.com/blog/2016/12/anesthetic-neurotoxicity-infants-children-current-state-art.html

 

[propadope]

Obviously there is much more research needed but I attended a lecture by a researcher on neurotoxicity. According to him, ketamine was the worst offender. Precedex and opioids were the best with precedex being possibly neuro protective

 

[urge]

"Since the existence of anesthetic neurotoxicity in children is still unclear, conversations with parents should be undertaken with care. Given the unclear benefit of such a discussion, there does not appear to be a compelling medical argument to actively raise this concern during the anesthetic consent process. If families or clinicians have questions about anesthetic neurotoxicity, physician anesthesiologists should be prepared to answer them and participate in discussions with the perioperative team. Conversations about modifying medical care should be undertaken with particular caution, as unintended harmful consequences may result from delaying necessary surgery or changing a patient’s anesthetic management. "- This statement is from: A 2015 consensus statement about the use of anesthetics in children is available from SmartTots, a collaborative effort between the International Anesthesia Research Society, U.S. Food and Drug Administration and many others working together to make anesthesia safer for infants and children. The consensus statement has been endorsed by a wide range of anesthesia and pediatric societies including the American Society of Anesthesiologists and Society for Pediatric Anesthesia.


http://www.kevinmd.com/blog/2016/12/anesthetic-neurotoxicity-infants-children-current-state-art.html

Emphasis on 2015 consensus statement.

It it a different world now. A week ago you could ignore it but I don't think you can now.

 

[Noyac]

Emphasis on 2015 consensus statement.

It it a different world now. A week ago you could ignore it but I don't think you can now.

Agreed. I just had a dental pts mom ask me about this. And she wasn't someone I would consider "well informed".

 

[drmwvr]

If there's a silver lining here, maybe it will be that the surgeons speed up a little.

 

[IlDestriero]

"Since the existence of anesthetic neurotoxicity in children is still unclear, conversations with parents should be undertaken with care. Given the unclear benefit of such a discussion, there does not appear to be a compelling medical argument to actively raise this concern during the anesthetic consent process. If families or clinicians have questions about anesthetic neurotoxicity, physician anesthesiologists should be prepared to answer them and participate in discussions with the perioperative team. Conversations about modifying medical care should be undertaken with particular caution, as unintended harmful consequences may result from delaying necessary surgery or changing a patient’s anesthetic management. "- This statement is from: A 2015 consensus statement about the use of anesthetics in children is available from SmartTots, a collaborative effort between the International Anesthesia Research Society, U.S. Food and Drug Administration and many others working together to make anesthesia safer for infants and children. The consensus statement has been endorsed by a wide range of anesthesia and pediatric societies including the American Society of Anesthesiologists and Society for Pediatric Anesthesia.


http://www.kevinmd.com/blog/2016/12/anesthetic-neurotoxicity-infants-children-current-state-art.html

Nothing has changed since the above. The FDA is, as usual, a couple years late to the party. So much so that the lack of more evidence in the last 5 years or so of heavy research is probably reassuring that our routine anesthetics are safe.
The only truly elective cases I do on young kids are probably circs, and many of them aren't completely elective. There may be a place to decrease some of the endless waves of MRIs we do though. We have 2 or 3 scanners going 5 days a week.
The only thing that might change is more parents asking about it again. The answer hasn't changed. We work as quickly as possible, only give the minimum amount of drugs needed and generally don't do unnecessary elective procedures on babies. There is no convincing evidence to use or avoid particular drugs, all of which have their own side effects, etc. so I'm not changing anything. This is all CYA, "in an abundance of caution" BS.
The urology position has been "come back when there's proof and we will talk." MAYBE they will put their own consensus statement together about what's truly elective and what could wait until 3 or even 5yo.

--
Il Destriero

 

[dmk5n]

FDA = Fear mongering.

 

[Mman]

That is very good. But it was last year's talk. I maintain my position that is different from all consents you have ever obtained.

The doctrine of consent hasn't changed since 2015. You are still not required to disclose every possible risk. You are certainly not required to disclose risks that the biggest warning you can find says we really don't know the magnitude or significance of any possible effect. You are required to have the discussion if asked.

The actual FDA warning itself says the best evidence shows a single anesthetic is unlikely to have negative effects. So when the parents come in for a single short elective procedure, am I supposed to say we have evidence that this isn't going to do anything bad to your child? I mean how many kids are you seeing for repeated elective surgeries on?

The doctrine of informed consent has not changed.

 

[epidural man]

Why beat around the issue? Tell parents that data shows it damages brains according to the FDA. The patients or parents make a choice. I often tell patients - "really bad stuff could happen. The list is extremely long. But two common things happen - sore throat, nausea and vomiting. " Then I actually read the part of general anesthesia risks with them on the consent....really bad stuff on those risks.

I've never had a patient say - oh really? I could have a heart attack? I don't want my umbilical hernia fixed then.

I'm just saying - if we are worried about informed consent - telling the patients - just saying it's a possible scientific finding. I don't think anyone could argue that you did anesthetic knowing it would hurt the child without telling them - if you in fact told them. I don't think parents will care - or change their mind. They have already been told that horrible things might happen - but that it is very unlikely. Just add this to the list.

 

[propadope]

http://www.journalmc.org/index.php/JMC/article/view/2453/1802

Thoughts?

 

[propadope]

https://anesthesiology.pubs.asahq.org/article.aspx?articleid=2536217

What We Already Know about This Topic

• The developing brain is susceptible to injury induced by anesthesia or painful interventions in early childhood
  
  
• Studies have found a variable association between anesthesia in early life and long-term neurodevelopment
  

What This Article Tells Us That Is New

• Children who undergo surgery before primary school age are at increased risk of early developmental vulnerability, but the magnitude of the risk is small
  
  
• Contrary to previous reports, age less than 2 yr at first exposure or multiple exposures to surgery did not increase the risk of adverse child development
  

 

[caligas]

These studies are just correlation right, no evidence of causality?