Intranasal Ketamine for Procedural Sedation

• Status: Unknown status
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Ketamine

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)