[B]I have just finished the first draft abstract – deadline is Dec 4 at 5 pm for SAEM. I would appreciate any and all feedback re below. In particular the results section will need to be fleshed out given our ongoing data analysis, but everything else is up for comment also.[/B]
[B]Background[/B]: Ketamine and Propofol have both been studied independently as agents for pediatric sedation in the Emergency Department (ED). Ketamine use can result in side effects of vomiting, emergence reactions, and extended recovery periods. Propofol is becoming increasingly popular as it offers rapid onset of sedation and recovery, and intrinsic anti-emetic properties. However, use of this agent can result in hypotension and respiratory depression. There are theoretical advantages to the combination of ketamine and propofol for ED sedation, and previous literature has suggested that the combination may provide an attractive alternative either agent alone. The combination has not previously been studied prospectively in a pediatric ED population. Performing a blinded study using propofol in particular has been been problematic given the distinctive milky white appearance of the agent.
[B]Objectives:[/B] We hypothesized that the time to recovery from sedation would be decreased in children receiving Ketamine-Propofol as compared to children receiving Ketamine alone. We hypothesized that incidence of complications and adverse events, and satisfaction scores would be superior in the Ketamine-Propofol group as compared to Ketamine alone. We tested these hypotheses in children requiring sedation for isolated extremity injury at an academic pediatric emergency department, incorporating a propofol blinding strategy utilizing Intralipid as our propofol placebo.
[B]Methods:[/B] This prospective randomized double-blind study evaluated time to recovery, complication and adverse event rates, satisfaction scores, and time to procedure start in ____ children aged 2 to 17 requiring sedation for isolated orthopedic extremity injury in an academic pediatric emergency department. Patients were randomly allocated to two groups. The Ketamine-Propofol group received an initial dose of ketamine .5 mg/kg IV and propofol .5 mg/kg IV, followed by propofol .5 mg/IV and saline placebo every 2 minutes as needed to reach a Children’s Hospital of Wisconsin sedation score of 2 or less. The Ketamine group received an initial dose of ketamine 1.0 mg/kg IV and a milky white placebo agent (Intralipid), followed by ketamine .5 mg/kg IV and (Intralipid) placebo q2 minutes to reach a sedation score of 2 or less. Recovery time was defined as the interval between the time the last study drug was injected to the time a recovery score of 8 on a modified Aldrete scale was achieved. Study data points and patient, nurse and physician satisfaction scores were recorded at the bedside by dedicated research assistants. Study drug packs were prepared outside of the ED by the research pharmacy. Research assistants, physicians, nurses and patients were blinded to the randomization arm. Patients were recruited from ____ 2007 to _______ 2008. Patients were excluded if they had multiple orthopedic injuries requiring reduction, respiratory tract infection, hemodynamic instability, recent head injury, known seizure disorder, significant underlying heart or lung disease, craniofacial anomaly, adrenocortical dysfunction, pregnancy, intoxication, and allergy to eggs, soy or the study drugs.
[B]Results:[/B] ______ patients were studied. Children in the Ketamine-Propofol recovered ___ minutes faster than the Ketamine only group. Complication rates were ___ in the KP group and ____ in the K group. Adverse events occurred in ___ of the KP group and _____ of the K group. There no were serious complications or adverse events. Nausea/vomiting occurred in ___ of the KP group and _____ of the K group. Respiratory events/complications occurred in ___ of the KP group and _____ of the K group. Time to procedure start was __ minutes in the KP group and ___ in the K group. Overall, both agents showed ?good ?excellent tolerability, side effect profile, and satisfaction scores.[B]Conclusions:[/B] I have two conclusions and would appreciate your thoughts on which one is more appropriate:
Ketamine-Propofol is a super cool drug combo and one would have to be mental not to use it, in fact we would go so far as to say it would border on medical malpractice to not use it. So don’t be green and stick with ketamine, heed the call and use ketamine-propofol. (kind of catchy)
The combination of ketamine and propofol is an effective method of pediatric sedation, providing more rapid recovery than ketamine alone, with similar? Improved? rates of patient, physician and nurse satisfaction and similar? Improved? rates of adverse events/complications.