- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02828566
Intranasal Ketamine for Procedural Sedation (INK)
Intranasal Ketamine Versus Intravenous Ketamine for Procedural Sedation in Children: a Multi-centre Randomized Controlled Non-inferiority Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Naveen Poonai, MD
- Phone Number: 52011 5196858500
- Email: naveen.poonai@lhsc.on.ca
Study Contact Backup
- Name: Cindy Langford, RN
- Phone Number: 52011 5196858500
- Email: cindy.langford@lhsc.on.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 4 -17 years
- Up to 80 kg
- Presenting the paediatric emergency department
- Require a closed reduction by procedural sedation and analgesia
- Acute (=< 48 hours) distal radius and/or ulna fracture that is angulated with or without displacement
- No more than 0.5 cm shortening in either the radius or ulna (not both)
Exclusion Criteria:
- Previous hypersensitivity reaction to ketamine
- Globe rupture
- Traumatic brain injury with intracranial hemorrhage
- History of uncontrolled hypertension
- Nasal bone deformity
- Duration of reduction expected to be greater than 20 minutes
- Poor English or French fluency in the absence of a native language interpreter
- American Society of Anesthesiologists (ASA) class of 3 or greater
- Previous sedation with ketamine within 24 hours
- Previous diagnosis of schizophrenia or psychosis based on DSM-V criteria
- Pregnancy
- Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction
- Multi-limb trauma
- Hemodynamic compromise
- Glasgow coma score < 15
- Fracture is comminuted
- Fracture is associated with a dislocation
- Hematoma block at index visit
- Unilateral or bilateral nasal obstruction (due to infectious or allergic rhinitis, nasal polyps, septal hematoma, or septal deviation)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IN ketamine and IV saline
Ketamine, single dose, 10 mg/kg (0.1 mL/kg) of 100 mg/mL solution delivered intranasally using an atomizer and divided to both nares to a maximum of 800 mg (8 mL) AND 0.9% normal saline (NS) 0.02 to 0.03 mL/kg delivered intravenously to a maximum of 2.4 mL
|
Intranasal ketamine 100 mg/mL solution (10 mg/kg, maximum 800 mg)
Other Names:
Intravenous 0.9% normal saline
|
Active Comparator: IV ketamine and IN saline
Ketamine, single dose, 1 to 1.5 mg/kg (0.02 to 0.03 mL/kg) of 50 mg/mL solution delivered intravenously, to a maximum of 120 mg (2.4 mL) AND 0.9% normal saline (NS) 0.1 mL/kg delivered intranasally using an atomizer and divided to both nares, to a maximum of 8 mL
|
Intravenous ketamine 50 mg/mL solution (1 to 1.5 mg/kg, maximum 120 mg)
Other Names:
Intranasal 0.9% normal saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adequacy of sedation
Time Frame: Duration of fracture reduction
|
Proportion with DOCS score -2 to +2 for duration of fracture reduction
|
Duration of fracture reduction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depth of sedation
Time Frame: Duration of fracture reduction
|
Score using Pediatric Sedation State Scale
|
Duration of fracture reduction
|
Onset of adequate sedation
Time Frame: Within 1 hour following intervention
|
Time interval from first IN sprays to first DOCS score between -2 and +2 in minutes
|
Within 1 hour following intervention
|
Duration of sedation
Time Frame: Within 2 hours following intervention
|
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
|
Proportion of time participant adequately sedated during fracture reduction
Time Frame: Within 2 hours following intervention
|
Proportion of time DOCS score is -2 to +2 during fracture reduction.
|
Within 2 hours following intervention
|
Adverse events
Time Frame: Within 2 hours following intervention
|
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
|
Length of stay due to PSA
Time Frame: Within 3 hours of intervention
|
Time interval from the first pair of IN sprays to discharge
|
Within 3 hours of intervention
|
Duration of procedure
Time Frame: Within 3 hours of intervention
|
Time of the first pair of IN sprays to the end of cast or splint application
|
Within 3 hours of intervention
|
Caregiver satisfaction
Time Frame: Within 2 hours of intervention
|
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
|
Participant satisfaction
Time Frame: Within 2 hours of intervention
|
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
|
Physician satisfaction
Time Frame: Within 2 hours of intervention
|
Obtained immediately prior to discharge using a Visual Analog Scale
|
Within 2 hours of intervention
|
Nurse satisfaction
Time Frame: Within 2 hours of intervention
|
Obtained immediately prior to discharge using a Visual Analog Scale
|
Within 2 hours of intervention
|
Requirement for additional sedative medication
Time Frame: Within 2 hours of intervention
|
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
|
Analgesic medication
Time Frame: Within 2 hours of intervention
|
Number of doses and type of analgesic medication required
|
Within 2 hours of intervention
|
Pain
Time Frame: Within 2 hours of intervention
|
Pain scores will be recorded using the FPS-R on arrival and when the child is awake and drinking
|
Within 2 hours of intervention
|
Emergence delirium
Time Frame: 20 to 80 minutes post-IV intervention
|
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
|
Nasal irritation
Time Frame: Within 2 hours following intervention
|
Measured using the Faces Pain Scale - Revised when awake and drinking
|
Within 2 hours following intervention
|
Successful sedation
Time Frame: Within 2 hours following intervention
|
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
|
Adjunctive IV therapy
Time Frame: Within 2 hours following intervention
|
Other reasons for IV insertion (analgesia, anxiolysis, fluids, etc.)
|
Within 2 hours following intervention
|
Number of IN sprays received / Intended number of sprays
Time Frame: Within 2 hours following intervention
|
Number of IN sprays received / Intended number of sprays
|
Within 2 hours following intervention
|
Number of IV attempts
Time Frame: Within 2 hours following intervention
|
Number of IV attempts and time to IV insertion Number of IV attempts
|
Within 2 hours following intervention
|
Time to IV insertion
Time Frame: Within 2 hours following intervention
|
Time from first breakage of skin to establishment of successful flow with a flush
|
Within 2 hours following intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Naveen Poonai, MD, Western University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Fractures, Bone
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- 106550
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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