Hey gang, here is the first draft. Please suggest additions/deletions and I will reformat after all suggestions are in! kc
Hi Karalyn, Looks good. I suggest you have a 2-sided pocket card with one side containing the dosing information and adverse events for KP and the other side for Propofol only. BOTH sides should have the procedures and inclusion/exclsuion criteria. Any additional thoughts? When can we send this in? Shelley
Looks good, but I agree with Shelley’s comment about including the dosing schedule for both arms.AM
I agree it looks good. The 2 sided idea is a wise one.I would suggest we remove the word “administration” as it is redundant and we could save some space.What do you think of adding “analgesia as per MD choice” under the dosing schedules? I found with the peds KP study there was always some question by the MD’s as to whether or not they can give parenteral analgesia while the sedation was ongoing.And as to the O2 issue, we can add a line stating “O2 for sats <92%”. This assumes we are going with the no O2 until hypoxic method and will depend on buy in. I would suggest we try to persuade our colleagues to go with the O2 only if sats <92%. I’m using the 92% as this is the cutoff we’ve got on our recovery scale. Thoughts?Cheers,Greg
The analgesia issue is a tough one. The ketamine dose involved should have more than enough analgesic effect. My bet is that it would mostly be propofol-alone patients that would be getting analgesia and that might account for any difference in safety data (e.g. if all the patients who desat got whopping doses of fentanyl). I’m not sure how to best address this issue: I certainly don’t want to deprive patients in the P-alone group of analgesia purely for the sake of the study (although there are a large number of docs who don’t routinely give analgesics with propofol). It’s also a small enough sample size that adjusting for analgesic co-interventions would be tough. How did you guys do it in the kids study?AM
Great comments - I will make sure that it is two sided, with appropriate info for each arm on each side. Sounds good! I think that analgesia should be MD choice myself - we are still at the “pilot” stage so it will give us info to use in developing studies in the future. I also agree that the line “Supplemental O2 for sats <92%” should be an included line. I would love to have this finished by Monday as it is the only thing holding up our resubmission. I will complete a revised copy by tonight and hopefully we can all finalize by Monday! kc
Second draft of the PocketCard!
I like it! Couple of suggestions:The age should be >17 as we will be seeing 18 year olds.The study title should not be bolded but I would bold the arm titles to make it clear and obvious which drug/combo is being addressed on that particular side of the card.Andrew, to answer your question, there was a lot of confusion over whether or not to give analgesia and when. Some kids were clearly difficult because they had not received adequate doses of analgesia. They sometimes required sedation beyond the study drug aliquots. I think that making it explicit that the MD can give as much as is necessary makes it more ethical, realistic and satisfies individual clinical judgement. It did not seem to mess with our results.Cheers,Greg
Looks great guys! Very envious of a great study. Count on my support.As a mono-therapy kind of guy I most often do not give analgesia when I use propofol. I count on its amnesic properties much like “when a tree falls in a forest philosophy”, if you experienced pain but do not remember that pain, did it actually happen? I know what the pain people say, but I’m just a simple emerg doc trying to make my way in this complicated medical environment. :DR
This looks like a great study… can’t wait to get started!
Hey, thanks Rob and Crispen for the support. We’re looking forward to the Nobel at the end of it all.