The trial (Intranasal ketamine for procedural sedation in children: a randomized controlled
non-inferiority multicenter trial or INK; ReDA 5496; CTO 1545) is being scheduled for launch
in Spring 2019. Due to the possibility of failure of the experimental intervention
(intranasal ketamine 10 mg/kg), the data safety monitoring board (DSMB) and statistical
methods team would like to explore the possibility of developing a stopping rule to prevent
patients from being enrolled in a futile trial and conserve resources. In order to get
accurate data to develop a statistically robust stopping rule, it is necessary to conduct a
cohort study of patients that receive the INK trial's experimental intervention and according
to it's protocol. This cohort study will help estimate the chance of adequate sedation and
inform the final dosing protocol for the INK trial.