Ketofol receives Health Canada approval!

[FONT=Arial][SIZE=2]Hello All, Just a quick note to inform you that earlier this afternoon we received the final approval [B](Letter of No Objection) from Health Canada[/B] to go ahead with the Ketofol project![B] Hooray![/B] Looks like the start of the study will ABSOLUTELY be June 4th. I will forward a copy of the NOL to the UWOP HSREB and the Lawson IRF committee so we can have our $5,000 transferred. A [B]HUGE[/B] thank you to all those involved in the application and proposal. Shelley:D [/SIZE][/FONT]

Congrats guys!

A HUGE thank you to all those involved in the application and proposal. Hear hear. That is great news. We are starting to pick up speed…Kris

Great news and good progress on the assistants. I gave an update to the peds unit council regarding our project. It was very well received. There was great interest and support for the project. I will send an email update to the peds group on our study progress within a day. Unfortunately I am out of town on May 28th and cannot present to the peds ER group that am. Is there anyone else who might be free to present to the peds ER group? Or perhaps an alternate time we can do this? Amit

Hi All,I will be at the Peds Dept mtg on May 28. If I remember correctly, Amit, you presented your powerpoint talk at that mtg in the past. If so, we need to present the final double blinded protocol and the logistics of the study. I can do that, unless Kris or Mike P. want to do it. We can also do it together and split it into sections. I am open to your suggestions.Cheers,Greg

Greg - I managed to switch my shift around Monday and can come now. I have been in contact with Shelley today. We will present logisitics and study data/protocol specifically.

Sounds great. See you there.Cheers,Greg

Greg and Shelley I have gone through the protocol again. Greg, I agree with your thoughts from yest as to when to switch from Sedation scoring to Recovery Scale. We proceed with continued sedation until sedation score is <3. Once this occurs, procedure starts and scoring is switched to the recovery scale. A variance will occur when the procedure is more prolonged than a simple reduction - additional drugs may need to be given while our assistant has already switched over to the Aldrete Recovery Scale. We need to firm up how we will handle this. I think we should stay on the Aldrete Recovery Scale during these occasions, and simply document times of additional drugs being given. We know that for these instances, we will have already achieved a sedation score of <3 - the issue will not be insufficient sedation but rather insufficient length of sedation or prolonged length of procedure. It will be sufficient for our database and research purposes to know how many additional doses of agent were required and when, and if there were any complications. I wondered if there would be any advantage or need to go back to the Sedation Scale in these instances, but I don’t think there would be. I believe this is also what we agreed on yest, but I wanted to make sure. The other question is who actually produces the data for the Recovery scale. I believe we have agreed that the Research assistant will ask the nurse for the subjective elements of the score (level of consciousness and activity level), record these and the VS parameters, and do the totalling of the score. I will make some slides showing study protocol, data sheets, and the Wisconsin Score and Aldrete Scale. Greg will discuss the role of the research assistants and their protocol. Greg let me know if that is ok. I will check the BB on Sun night, or call me sun night 641-6170. Just FYI I have sent a brief note to Marco in Kingston and Gary in BC to let them know of our study progress and protocol - it would be great to do a collaborative study with them in the future and I last updated them in the fall. We have made a lot of progress since then. Booyookasha! Amit

Hey Amit,Any additional study drug given once the procedure has started will be documented on the RN sedation sheet with a time so we should be able to capture that. It shouldn’t happen too often and we can just mention it as a discreet occurence on a case by case basis per arm of the protocol (say that fast after a couple o’ cool ones).Depending on the level of the RA, I think she’ll be able to do a lot of the scoring with minimal input from the docs and nurses as time goes on. At first, I think there will have to be a lot of mutual assistance going on. We should keep track and see how it goes. I intend to spend some time in the Peds ED on June 4th to help with the initial growing pains.I sent out an RA duties checklist by email to everyone. I can bring it as a slide for tomorrow as well.Cheers,Greg