- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02402868
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children
Intranasal Ketamine Versus Intravenous Ketamine for Procedural Conscious Sedation in Children: a Multi-centre Randomized Controlled Non-inferiority Trial
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
Ontario
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London, Ontario, Canada, N6A5W9
- Children's Hospital, London Health Sciences Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients 5-17 years (up to 80 kg) presenting to the paediatric ED who require a PCS for an acute simple orthopedic injuries who require a procedural sedation and analgesia (PSA). A "simple" injury is defined as a fracture or dislocation that: 1) Angulated with or without displacement but is not shortened) 2) Non-comminuted
Exclusion Criteria:
- 1) Previous hypersensitivity reaction to ketamine including rash, difficulty breathing, hypotension, apnea, or laryngospasm 2) Globe rupture 3) Traumatic brain injury with intracranial hemorrhage 4) History of uncontrolled hypertension 5) Nasal bone deformity 6) Fracture reduction expected to require > 20 minutes 7) Poor English fluency 8) American Society of Anesthesiologists (ASA) class of 3 or greater 9) Previous sedation with ketamine within 24 hours of index visit 10) Known diagnosis of schizophrenia or active psychosis 11) Pregnancy
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: Intranasal ketamine and saline
Intranasal ketamine (each single dose, 8 mg/kg prepared in 0.9% NS in 3 mL syringe and atomizer, to a maximum of 6.4 mL) PLUS IV 0.9% NS 0.02 mL/kg
|
Ketamine intravenous and intranasal
Other Names:
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Active Comparator: Intravenous ketamine and saline
Intravenous ketamine (single dose, 1 mg/kg, to a maximum 100 mg) PLUS intranasal 0.9% NS 0.08 mL/kg divided to both nares
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Ketamine intravenous and intranasal
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
University of Michigan Sedation Score
Time Frame: From the time the IV intervention is given to 60 minutes post intervention or when drinking, whichever is longer
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The primary outcome is the UMSS score at 10 minutes post administration of the IV intervention compared to UMSS score immediately prior to the first IN intervention (delta) using the University of Michigan Sedation Scale (UMSS)
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From the time the IV intervention is given to 60 minutes post intervention or when drinking, whichever is longer
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Onset of sedation
Time Frame: Within 1 hour following intervention
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Time interval from first IN spray to UMSS score of greater than 3 in minutes
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Within 1 hour following intervention
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Duration of sedation
Time Frame: Within 2 hours following sedation
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Time interval from UMSS score greater than 3 to a UMSS score of 0 in minutes
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Within 2 hours following sedation
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Adverse events
Time Frame: Within 2 hours following sedation
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Obtained when patient fully awake and prior to discharge from the participant, physician report and corroborated with nursing sedation record
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Within 2 hours following sedation
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Length of stay
Time Frame: Within 3 hours of intervention
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Time from arrival in ED bed to discharge in minutes
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Within 3 hours of intervention
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Length of stay due to sedation
Time Frame: Within 3 hours of intervention
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Time from first IN spray to discharge in minutes
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Within 3 hours of intervention
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Duration of procedure
Time Frame: Within 3 hours of intervention
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Time from first IN spray to end of cast application
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Within 3 hours of intervention
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Parental satisfaction
Time Frame: Within 2 hours of sedation
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Obtained immediately prior to discharge using a 5-item Likert scale; Parents not wishing to remain in proximity of child for sedation may opt out
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Within 2 hours of sedation
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Child satisfaction
Time Frame: Within 2 hours of sedation
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Obtained immediately prior to discharge using a 5-item Likert scale
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Within 2 hours of sedation
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Sedating physician satisfaction
Time Frame: Duration of ED visit
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Obtained immediately prior to discharge using a 5-item Likert scale
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Duration of ED visit
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Adjunctive sedative medication
Time Frame: Duration of ED visit
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Number of doses and type of adjunctive sedative medication required
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Duration of ED visit
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Analgesic medication
Time Frame: Duration of ED visit
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Number of doses and type of analgesic medication required
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Duration of ED visit
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Pain
Time Frame: 15 minutes prior to and 2 hours post intervention
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Child's self reported pain score using the Faces Pain Scale - Revised
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15 minutes prior to and 2 hours post intervention
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Emergence Agitation
Time Frame: Every 5 minutes for 60 minutes starting 20 minutes post IV intervention
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Degree of emergency agitation and delirium as recorded by observer using the Paediatric Anesthesia Emergency Delirium (PAED) scale
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Every 5 minutes for 60 minutes starting 20 minutes post IV intervention
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Nasal Irritation
Time Frame: Within 1 hour of intervention
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Recorded using a 5-item Likert scale anchored from 1=none to 5=very severe when child has a UMSS score of 0 and is awake and drinking
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Within 1 hour of intervention
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Successful sedation
Time Frame: From time of first IN spray to when participant is fully awake (UMSS score of 0 for 15 minutes)
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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 |
From time of first IN spray to when participant is fully awake (UMSS score of 0 for 15 minutes)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Naveen Poonai, MD, Western University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
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
- 106549
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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