The aim of the Strategy for Patient-Oriented Research Innovative Pediatric Clinical Trials Project (SPOR IPCT) is to develop and test innovative statistical and logistical clinical trial methods with a carefully selected set of four pediatric trails, using a centralized trial management structure and recruiting at six pediatric emergency departments in four Canadian provinces. In a partnership with Pediatric Emergency Research Canada (PERC), the EnRICH Lab leads the Methods Core for this CIHR funded four-year project. The four trials, all set in the emergency department, were chosen based on their potential to benefit from innovative methods as well as on the prevalence of the conditions they address.
- The No-OUCH trial will use a patient preference approach to randomization to evaluate the comparative effectiveness of ibuprofen alone, or in combination with acetaminophen or hydromorphone, in clinical pain relief for suspected fractures.
- The The DOSE-AGE Study is a pragmatic trial that will evaluate the safety and efficacy of multiple doses of ondansetron administered post-discharge to children with acute gastroenteritis.
- The INK study will evaluate the use of intranasal versus intravenous ketamine as a less painful experience in procedural sedation as it correlates with child satisfaction and healthcare team morale.
- The Bronchiolitis trial builds on previous evidence and will definitively confirm whether combination therapy with epinephrine and dexamethasone is effective in treating bronchiolitis and reducing infant hospitalizations.
These four conditions (suspected fractures, acute gastroenteritis, procedural sedation, and bronchiolitis) are estimated to affect over 17,300 children across our 6 recruiting sites every year. These trials will serve as proof of concept and enable us to build capacity in the design, conduct, and reporting of pediatric clinical trials that could be applicable to any pediatric subspecialty. The study team, led by Dr. Terry Klassen, was awarded a SPOR Innovative Clinical Trials multi-year grant by CIHR.
Updated February 2022