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NMDA receptor antagonist
Intranasal Ketamine for Pain Control in Patients with Sickle Cell Disease and Vaso-occlusive Episode (VOE) in the PED
Phase 3
Waitlist Available
Research Sponsored by Abigail Nixon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will study whether intranasal ketamine can help relieve pain for children with sickle cell disease who are in the midst of a vaso-occlusive crisis and are waiting for an IV line to be placed.
Eligible Conditions
- Sickle Cell Disease
- Sickle cell crisis
- Pain relief
- Intranasal Ketamine
- Sickle Cell Crisis
- Ketamine
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Pain Score Using Numeric Rating Scale (age>11yr)
Change in Pain Score Using Wong Baker/FACES (age<11yr)
Pain
Secondary study objectives
Additional Opiate Medication
Patient Satisfaction
Rate of Admission
+1 moreAwards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
Active Control
Group I: Intranasal Ketamine + Standard AnalgesiaActive Control1 Intervention
Enrolled patients will receive one dose of Intranasal Ketamine dosed at 1mg/kg (Ketamine 500mg/10 mL solution) after triage while waiting for IV placement (max 50mg).
Group II: Standard AnalgesiaActive Control1 Intervention
Patients receiving "no intervention" will receive no intranasal ketamine while awaiting intravenous line placement for parenteral pain control.
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Who is running the clinical trial?
Abigail NixonLead Sponsor