Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT02828566
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
17 Years
Study:
NCT02828566
Study Brief:
Protocol Section:
NCT02828566