Bone Fractures Clinical Trial
— INKOfficial title:
Intranasal Ketamine Versus Intravenous Ketamine for Procedural Sedation in Children: a Multi-centre Randomized Controlled Non-inferiority Trial
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).
Status | Not yet recruiting |
Enrollment | 470 |
Est. completion date | February 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 17 Years |
Eligibility |
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) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Lawson Health Research Institute |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adequacy of sedation | Proportion with DOCS score -2 to +2 for duration of fracture reduction | Duration of fracture reduction | |
Secondary | Depth of sedation | Score using Pediatric Sedation State Scale | Duration of fracture reduction | |
Secondary | Onset of adequate sedation | Time interval from first IN sprays to first DOCS score between -2 and +2 in minutes | Within 1 hour following intervention | |
Secondary | Duration of sedation | Duration of time between the first DOCS score -2 to +2 to last DOCS score between -2 and +2 post-fracture reduction | Within 2 hours following intervention | |
Secondary | Proportion of time participant adequately sedated during fracture reduction | Proportion of time DOCS score is -2 to +2 during fracture reduction. | Within 2 hours following intervention | |
Secondary | Adverse events | The proportion of participants with adverse effects between groups will be compared. The list of adverse effects was chosen based on known adverse effects associated with ketamine and consensus-based recommendations for reporting for procedural sedation and analgesia in children. | Within 2 hours following intervention | |
Secondary | Length of stay due to PSA | Time interval from the first pair of IN sprays to discharge | Within 3 hours of intervention | |
Secondary | Duration of procedure | Time of the first pair of IN sprays to the end of cast or splint application | Within 3 hours of intervention | |
Secondary | Caregiver satisfaction | Obtained when patient is awake and drinking using a Visual Analog Scale; Parents not wishing to remain in proximity of child for sedation may opt out | Within 2 hours of intervention | |
Secondary | Participant satisfaction | Obtained when patient is awake and drinking using a Visual Analog Scale; Satisfaction will only be assessed in children at least eight years of age as the VAS has not been validated in younger children. | Within 2 hours of intervention | |
Secondary | Physician satisfaction | Obtained immediately prior to discharge using a Visual Analog Scale | Within 2 hours of intervention | |
Secondary | Nurse satisfaction | Obtained immediately prior to discharge using a Visual Analog Scale | Within 2 hours of intervention | |
Secondary | Requirement for additional sedative medication | Number of doses and type of adjunctive sedative medication required; Deemed inadequate if additional sedative medication given (for IN ketamine group only) | Within 2 hours of intervention | |
Secondary | Analgesic medication | Number of doses and type of analgesic medication required | Within 2 hours of intervention | |
Secondary | Pain | Pain scores will be recorded using the FPS-R on arrival and when the child is awake and drinking | Within 2 hours of intervention | |
Secondary | Emergence delirium | The proportion of children experiencing emergence delirium will be compared using the Paediatric Anesthesia Emergence Delirium (PAED) scale scored from the video every 5 minutes by an outcome assessor starting when fracture reduction is complete to when awake and drinking | 20 to 80 minutes post-IV intervention | |
Secondary | Nasal irritation | Measured using the Faces Pain Scale - Revised when awake and drinking | Within 2 hours following intervention | |
Secondary | Successful sedation | Successful sedation - Based on the definition of Bhatt et al., this will be defined as no unpleasant patient recall of the procedure, no resistance or restraint required during the procedure, no permanent sedation-related complication or no sedation-related event requiring abandonment of the procedure. Defined as: no unpleasant patient recall of the procedure, no resistance or restraint required during the procedure, no permanent sedation-related complication or no sedation-related event requiring abandonment of the procedure. Defined as no unpleasant recall of procedure, no resistance or restraint, no permanent sedation related complication, no sedation-related event requiring abandonment of procedure |
Within 2 hours following intervention | |
Secondary | Adjunctive IV therapy | Other reasons for IV insertion (analgesia, anxiolysis, fluids, etc.) | Within 2 hours following intervention | |
Secondary | Number of IN sprays received / Intended number of sprays | Number of IN sprays received / Intended number of sprays | Within 2 hours following intervention | |
Secondary | Number of IV attempts | Number of IV attempts and time to IV insertion Number of IV attempts | Within 2 hours following intervention | |
Secondary | Time to IV insertion | Time from first breakage of skin to establishment of successful flow with a flush | Within 2 hours following intervention |
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