Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
Orthopedic injuries comprise more than 10% of ED visits in children and 25 to 50% of children
will sustain a fracture before age 16 years. Distal radius fractures account for 20-32% of
fractures in children, making them the most common fracture type. Between 20 and 40% of
extremity fractures in children require a closed reduction, often necessitating procedural
sedation and analgesia (PSA). Intravenous (IV) ketamine is the most commonly used sedative
agent used to perform a closed reduction. However, children rate IV insertion as the most
painful hospital experience, second only to the injury itself. IV insertion can be more
technically difficult in children because of smaller veins and lack of cooperation, often
leading to multiple IV attempts. A combination of intranasal (IN) dexmedetomidine plus
ketamine (IN Ketodex) may provide effective sedation for children undergoing a closed
reduction without the distress and pain related to IV insertion. A less painful experience
has been found to correlate with child satisfaction which may reduce caregiver anxiety and
improve the therapeutic relationship with the health care team. This study is a multi-centre,
two-arm, randomized, blinded, controlled, non-inferiority trial designed to test the
hypothesis that IN Ketodex is non-inferior to intravenous (IV) ketamine with respect to depth
of sedation as measured using the Pediatrics Sedation State Scale (PSSS).