The dumbest clinical trial I've ever seen.

[WVUPharm2007]

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[mentos]

At least it limited opioid use.

 

[Marzapan]

In other news, did y'all know that taking medications increases your risk of getting an adverse drug event? Don't do drugs, kids.

 

[confettiflyer]

all they need is a big boobed drug rep to peddle it and they’re set!

But seriously, stupid. Like how IV APAP is better :eye roll: and people bought that idea.

 

[gwarm01]

Ibuprofen better than nothing? I call BS.

 

[owlegrad]

So it's been a while since I took biostatistics, but does anyone else think this trial is morally questionable?

 

[KidPharmD]

So it's been a while since I took biostatistics, but does anyone else think this trial is morally questionable?

What makes you say that?

 

[owlegrad]

What makes you say that?

Because we already know NSAIDs are effective for pain and the people in the placebo arm got screwed.

 

[Sine Cura]

It's not like the placebo arm didn't get any opioid.

 

[KidPharmD]

Because we already know NSAIDs are effective for pain and the people in the placebo arm got screwed.

The study wasn't about Caldolor being effective for pain. It was about whether or not scheduling it reduced the amount of PRN opioids used in post-trauma patients. While that seems logical based on what we know about ibuprofen, it isn't a certainty until you study it. It isn't unethical because the control group got standard care which has been deemed sufficiently effective. A historical control might not have been possible if the standard care regimen hadn't been consistently defined in the past.

I actually think that these kind of studies are useful. They set the utility of these new drugs so that we can make better decisions on when they might be worth the cost. Reduction of opioid use is a big deal. Hopefully we will see a comparison of scheduled IV APAP and IV IBU soon for the same indication. Yes, we could have done this study with scheduled oral ibuprofen, but oral isn't without it's problems (especially with trauma patients). I'm glad we have this as an option and these kinds of studies help us allocate it in the hospital. At about $24/dose it isn't terribly prohibitive for something like a opiate reduction program.

 

[confettiflyer]

The study wasn't about Caldolor being effective for pain. It was about whether or not scheduling it reduced the amount of PRN opioids used in post-trauma patients. While that seems logical based on what we know about ibuprofen, it isn't a certainty until you study it. It isn't unethical because the control group got standard care which has been deemed sufficiently effective. A historical control might not have been possible if the standard care regimen hadn't been consistently defined in the past.

I actually think that these kind of studies are useful. They set the utility of these new drugs so that we can make better decisions on when they might be worth the cost. Reduction of opioid use is a big deal. Hopefully we will see a comparison of scheduled IV APAP and IV IBU soon for the same indication. Yes, we could have done this study with scheduled oral ibuprofen, but oral isn't without it's problems (especially with trauma patients). I'm glad we have this as an option and these kinds of studies help us allocate it in the hospital. At about $24/dose it isn't terribly prohibitive for something like a opiate reduction program.

In the right post-op setting yes, multi-modal works and is effective.

But the reality is in the execution, when internal medicine docs start using it because it’s “more effective” than PO/PR, and a 24hr course of APAP goes from pennies to $100...that’s a direct hit to pharmacy budget x hundreds of patient-days in a year.

Formulary control is key.

 

[KidPharmD]

In the right post-op setting yes, multi-modal works and is effective.

But the reality is in the execution, when internal medicine docs start using it because it’s “more effective” than PO/PR, and a 24hr course of APAP goes from pennies to $100...that’s a direct hit to pharmacy budget x hundreds of patient-days in a year.

Formulary control is key.

Agreed. These are some of those cases where I argue that strictly enforced prescribing restrictions are key to making sure that it is only used when it is actually cost effective. In my last adult job we were using a multi-modal plan on post-op ortho patients to get the out of bed doing PT/OT faster and thus getting them discharged faster. We had reduced all of our post-op stays by a day or two depending on the situation and it was easy to justify pretty much whatever they wanted to do in that cast.