Intranasal Ketamine for Procedural Sedation
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
About This Study
This study will examine the effectiveness of intranasal (IN) ketamine compared to standard intravenous (IV) ketamine administration for simple reductions of orthopaedic injuries in the paediatric population. The aim is to assess if IN administration is equivalent to the current standard of care, IV. The population to be studied is children 4-17 years of age who require a simple orthopaedic reduction. Following a double dummy approach to overcome the difficulty in masking interventions, each participant will receive both IV and IN interventions, only one of which will be the real drug. Procedural sedation and analgesia (PSA) will be assessed using the Dartmouth Operative Conditions Scale (DOCS).
Conditions Studied
Interventions
- •IN ketamine
- •IV ketamine
- •IN saline 0.9%
- •IV saline 0.9%
Eligibility
View full eligibility criteria
Inclusion Criteria: 1. Age 4 -17 years 2. Up to 80 kg 3. Presenting the paediatric emergency department 4. Require a closed reduction by procedural sedation and analgesia 5. Acute (=\< 48 hours) distal radius and/or ulna fracture that is angulated with or without displacement 6. No more than 0.5 cm shortening in either the radius or ulna (not both) Exclusion Criteria: 1. Previous hypersensitivity reaction to ketamine 2. Globe rupture 3. Traumatic brain injury with intracranial hemorrhage 4. History of uncontrolled hypertension 5. Nasal bone deformity 6. Duration of reduction expected to be greater than 20 minutes 7. Poor English or French fluency in the absence of a native language interpreter 8. American Society of Anesthesiologists (ASA) class of 3 or greater 9. Previous sedation with ketamine within 24 hours 10. Previous diagnosis of schizophrenia or psychosis based on DSM-V criteria 11. Pregnancy 12. Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction 13. Multi-limb trauma 14. Hemodynamic compromise 15. Glasgow coma score \< 15 16. Fracture is comminuted 17. Fracture is associated with a dislocation 18. Hematoma block at index visit 19. Unilateral or bilateral nasal obstruction (due to infectious or allergic rhinitis, nasal polyps, septal hematoma, or septal deviation)