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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult males with acute traumatic pain that are eligible to receive pain medication prior to hospital arrival under current practice will be screened for enrollment in the primary trial. The inclusion
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between pre-treatment ems assessment (baseline) and at 30-minutes post-treatment
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
Summary
This trial is looking at whether adding ketamine to fentanyl reduces pain more than fentanyl alone for people with acute pain from trauma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ between pre-treatment ems assessment (baseline) and at 30-minutes post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between pre-treatment ems assessment (baseline) and at 30-minutes post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Reduction in Pain
Awards & 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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: KetamineActive Control1 Intervention
50mg IN Ketamine Hydrochloride
Group II: PlaceboPlacebo Group1 Intervention
50mg IN placebo
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Who is running the clinical trial?
Jason McMullanLead Sponsor
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