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 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT05783492
Eligibility Criteria:
Inclusion Criteria:
* General Criteria
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Deemed by treating physician to require procedural sedation using ketamine Specific Criteria
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1. Children presenting to the paediatric EDs of participating sites age 7-17 years
2. Weighing up to and including 80 kg
3. Distal radius +/- ulna fracture or dislocation of a shoulder, elbow, patella, or digit
4. Closed reduction expected to take no more than 5 minutes to reduce (as determined by the procedure physician and not including cast or splint application).
Exclusion Criteria:
* 1\) Previous hypersensitivity reaction to ketamine including rash, difficulty breathing, hypotension, apnea, or laryngospasm; 2) Suspected globe rupture; 3) Concomitant traumatic brain injury with intracranial hemorrhage; 4) Uncontrolled hypertension; 5) Nasal bone deformity or nasal obstruction with at least one nare obstructed due to allergic or viral rhinitis, sinusitis, nasal polyps, or septal deviation; 6) Poor English or French fluency in the absence of native language interpreter; 7) American Society of Anesthesiologists (ASA) class 3 or greater; 8) Previous diagnosis of schizophrenia or active psychosis as per the treating physician 9) Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction; 10) Multi-limb trauma; 11) Hemodynamic compromise as per the treating physician; 12) Glasgow coma score \< 15; 13) Previous sedation with ketamine within 24 hours; 14) Fracture is comminuted or associated with a dislocation; 15) Participant has undergone a hematoma block within 24 hours; 16) Isolated ulna fracture; 17) Previous enrollment in the trial; 18) Suspected pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
17 Years
Study:
NCT05783492
Study Brief:
Protocol Section:
NCT05783492