Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation in Children with Fractures and Dislocations: An Adaptive Randomized Controlled Trial

What this Trial Is About

This research aims to evaluate sedation approaches for children with orthopedic injuries requiring procedural sedation in emergency departments. It focuses on comparing a combination of intranasal dexmedetomidine and ketamine (IN Ketodex) to the standard intravenous ketamine sedation. The study is a multi-center, randomized, blinded, controlled, non-inferiority trial designed to determine if IN Ketodex provides sedation as effectively as IV ketamine, potentially offering a less painful alternative for children who often experience distress from IV insertion. Participants receive one of several study treatments: three different doses of IN Ketodex combining dexmedetomidine and ketamine administered intranasally with a mucosal atomizer device, alongside a small intravenous saline placebo; or intravenous ketamine with intranasal saline placebo. The intranasal treatments vary in dosing levels to identify the most effective and tolerable combination. The trial includes dosing limits and delivery methods carefully defined to assess sedation depth and patient experience. Children aged 2 to 17 years with specific closed fractures or dislocations will participate in the study. Researchers will monitor sedation depth using the Pediatrics Sedation State Scale during the emergency department visit, lasting up to four hours. They will also assess length of stay, time to waking, and adverse effects up to 72 hours after discharge. The study tracks safety and effectiveness measures closely, aiming to improve procedural sedation options for pediatric orthopedic injuries.

Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation