Intranasal Dexmedetomidine plus Ketamine for Procedural Sedation in Children (KETODEX): an adaptive randomized controlled non-inferiority multicenter trial
OVERVIEW
Status: Recruiting
ClinicalTrials.Gov Identifier: NCT04195256
Principal Investigator: Dr. Naveen Poonai
Project Manager: Vinolia Arthur Hayward
PURPOSE
Musculoskeletal injuries occur very commonly in children and re-alignment of broken bones under sedation often needs to be performed.
Sedation usually requires an intravenous needle and children rate needle insertion is one of the most painful procedures that they experience in hospital.
In this trial, we are looking for a way to eliminate the need for an intravenous needle by giving sedative medications as a nasal spray.
OBJECTIVE
To determine if a combination of intranasal ketamine and intranasal dexmedetomidine (Ketodex) is just as effective as intravenous ketamine to sedate children undergoing realignment of a broken or dislocated bone.
POPULATION
410 children, age 7-17 years, across 6 Canadian paediatric emergency departments with one of the following injuries: fracture of the radius and/or ulna, fracture of a metacarpal or phalanx, or dislocation of an elbow or shoulder as long as it requires realignment.
IMPACT
We hope the results of this trial will help us find a less distressing approach to sedating children. A better hospital experience for children may make them less fearful of future medical encounters and this will in turn improve the therapeutic relationship between the health care team and families.