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IN Ketodex (D2K4) is an investigational intranasal combination drug formulation consisting of dexmedetomidine and ketamine. It is being evaluated for procedural sedation and analgesia (PSA) in pediatric patients (aged 4–17 years) undergoing closed reduction of orthopedic injuries, such as fractures and dislocations. Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist that provides sedative, anxiolytic, and analgesic properties without causing significant respiratory depression. Ketamine is an N-methyl-D-aspartate (NMDA) receptor antagonist that induces dissociative anesthesia and robust analgesia. The 'D2K4' designation specifies a sequential dosing regimen of intranasal dexmedetomidine at 2 mcg/kg followed by intranasal ketamine at 4 mg/kg, administered via a mucosal atomization device (MAD). This combination is designed to provide effective, non-invasive sedation, potentially eliminating the need for painful intravenous cannulation in children.
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