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Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children
Phase 3
Waitlist Available
Led By Naveen Poonai, MD
Research Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* 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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes prior to and 2 hours post intervention
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial
Summary
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 5-17 years of age who require a simple orthopaedic reduction. Following a double dummy approach to overcome the difficulty in masking interventions, each participant will recieve both IV and IN interventions, only one of which will be the real drug. Procedural conscious sedation (PCS) will be assessed using the University of Michigan Sedation Scale (UMSS).
Eligible Conditions
- Broken Bones
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of first in spray to when participant is fully awake (umss score of 0 for 15 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of first in spray to when participant is fully awake (umss score of 0 for 15 minutes)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
University of Michigan Sedation Score
Secondary study objectives
Adjunctive sedative medication
Adverse events
Analgesic medication
+12 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intranasal ketamine and salineExperimental Treatment1 Intervention
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
Group II: Intravenous ketamine and salineActive Control1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
Find a Location
Who is running the clinical trial?
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sLead Sponsor
670 Previous Clinical Trials
418,338 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
683 Previous Clinical Trials
431,403 Total Patients Enrolled
Naveen Poonai, MDPrincipal InvestigatorWestern University
5 Previous Clinical Trials
1,636 Total Patients Enrolled