Research Committee Update
By Joseph Cravero, MD
The Research Committee continues to work on several projects at this time.
A retrospective analysis of prospectively collected data on the use of ketamine combined with propofol (Ketofol) in the PSRC has recently been completed and has been submitted. This effort was led by Dr. Jocelyn Grunwell from Children’s Healthcare of Atlanta–Egleston.
In this study, nearly 8,000 patient encounters using ketofol were evaluated. Procedural success was documented in 99.7% of cases. There were no deaths, and serious adverse events were recorded in only 3.94% of cases. Risk factors for adverse events included ASA III or greater status, along with procedures performed in a dental suite or cardiac catheterization lab. Primary gastrointestinal diagnosis was also associated with greater risk as was the administration of an anticholinergic.
The manuscript was submitted to Pediatric Critical Care Medicine and the authors suggest that their data may be used to design appropriate-sized prospective trials of this medication combination in the near future.
In another retrospective analysis, Dr. Michael Mallory is currently leading a group that is analyzing data on the risk of sedation in children who have upper respiratory tract infections (URIs). In this case over 83,000 sedation encounters were available for analysis from the PSRC database. The project analysis is ongoing at this time, but the data does reveal that airway adverse events were statistically associated with upper respiratory tract infection status.
After adjusting for other variables, significantly elevated odds associated with current URI were observed for all airway adverse events in the cohort. Airway events including coughing, secretions requiring suction, stridor, and wheezing were associated with a URI within the last two weeks or with very recent upper respiratory tract infections when compared with patients who had no active symptoms or signs of infection. Inability to complete the procedure due to a problem with sedation was also associated with a current URI status. Notably, there were no deaths or very serious adverse outcomes in this cohort.
Although the study has not been completely finished at this point, the outcomes are in line with data from the field of anesthesiology where current or recent URI has been repeated found to be associated with an increased risk of minor/moderate airway adverse events but not serious morbidity or mortality. Implications for clinical care will need to be considered on a case-by-case basis.
The Research Committee is working hard to create a new paradigm for research within the PSRC and the SPS – that of the multicenter collaborative, observational trial. Projects coming under this category would involve a subset of institutions belonging to the PSRC that agree to collect and share detailed information on the practice of procedural sedation relating to a particular area of sedation practice. Notably, the information collected would be in addition to the standard information that is collected for the PSRC quality improvement data (and used for research projects as outlined above), and would be much more detailed concerning the particular area of data collection.
The first effort in this new direction for the PSRC is being led by Dr. Dan Tsze and involves a multicenter pilot study of intranasal dexmedetomidine for procedural sedation. The goal of this study will be to not only obtain information regarding clinically important outcomes associated with different doses and regimens of intranasal dexmedetomidine, but also to develop and refine the infrastructure and processes that will form the foundation necessary for future prospective multicenter trials to be conducted by the PSRC.