: Children undergoing non-surgical procedures are routinely sedated with either intravenous (IV) sedation or general anesthesia (GA) to ensure their safety, comfort, and cooperation. There are no prediction rules to guide the chief clinical decision as to which children should receive IV sedation and which should be referred to GA. Both types of sedation involve life-threatening risks to patient safety from unanticipated pharmacological effects or medical errors. Intolerance of IV sedation represents an additional important safety issue, as many children become highly agitated, risking unnecessary harm. The primary goal of this Mentored Career Development Award is to provide a mechanism for the candidate, a trained pediatric gastroenterologist, to develop skills in patient safety research while studying complex issues of sedation choice and patient safety, using gastrointestinal (GI) endoscopy as a high-volume procedural model. With strong mentorship in patient safety and clinical investigation and in collaboration with a multidisciplinary team that includes experts in research design, prediction rules, gastroenterology, anesthesiology and pediatric psychology, the candidate will: 1) use robust, precise methods to prospectively assess intolerance, other adverse events and medical errors during sedation for GI endoscopy; 2) utilize regression modeling to develop prediction rules to improve the safety of sedation for children undergoing this procedure; and 3) tailor existing taxonomies to classify medical errors associated with IV sedation for GI endoscopy. Primary and secondary outcomes data, including measures of intolerance, other adverse events, and errors related to sedation, will be collected in a large prospective, observational pediatric cohort study. The short term goals of this proposal are to allow the candidate to gain: 1) formal education in the quantitative and qualitative tools necessary for conducting health services research; 2) substantial training in the study of patient safety and improvement strategies for pediatric healthcare; and 3) valuable mentorship required to ensure her progress towards becoming an independent clinical scientist. The long-term goals of this research are to develop prediction rules for determining safe sedation regimens for children undergoing GI procedures that may lead to generalizable improvement strategies for pediatric sedation. ? ?

Agency
National Institute of Health (NIH)
Institute
Agency for Healthcare Research and Quality (AHRQ)
Type
Clinical Investigator Award (CIA) (K08)
Project #
5K08HS013675-02
Application #
6748417
Study Section
HSR Health Care Research Training SS (HCRT)
Program Officer
Anderson, Kay
Project Start
2003-06-01
Project End
2007-05-31
Budget Start
2004-06-01
Budget End
2005-05-31
Support Year
2
Fiscal Year
2004
Total Cost
Indirect Cost
Name
Children's Hospital Boston
Department
Type
DUNS #
076593722
City
Boston
State
MA
Country
United States
Zip Code
02115
Lightdale, Jenifer R; Valim, Clarissa; Newburg, Adrienne R et al. (2008) Efficiency of propofol versus midazolam and fentanyl sedation at a pediatric teaching hospital: a prospective study. Gastrointest Endosc 67:1067-75