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Nonsteroidal Anti-inflammatory Drug
Ketorolac Tromethamine for Analgesic Adverse Reaction
Phase 4
Waitlist Available
Led By Farzana Afroze, MD
Research Sponsored by Albany Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
-ASA physical status I to III, age of 2 years to 18 years old (inclusive) scheduled for elective tonsillectomy with or without adenoidectomy.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks post-operative
Awards & highlights
Study Summary
This trial will compare the bleeding rates of ketorolac and placebo when used for post tonsillectomy pain control in pediatric patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks post-operative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rebleeding rate requiring operative intervention
Secondary outcome measures
Number of emergency room visits/admissions
PACU length of stay
Post-operative opioid dosage
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ketorolac TromethamineExperimental Treatment1 Intervention
This group receives Ketorolac Tromethamine 0.5 mg/kg IV up to a maximum dose of 30mg, in the form of Ketorolac Tromethamine solution for IV/IM use 30mg/ml single dose vial at the completion of the tonsillectomy in the operating room.
Group II: 0.9% Normal SalinePlacebo Group1 Intervention
This group will receive 0.9% Normal Saline solution 1ml/60kg up to 1ml IV bolus (an equivalent volume as per kg Ketorolac Tromethamine dose) at the completion of the tonsillectomy in the operating room.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketorolac
FDA approved
Find a Location
Who is running the clinical trial?
Albany Medical CollegeLead Sponsor
91 Previous Clinical Trials
10,897 Total Patients Enrolled
Farzana Afroze, MDPrincipal InvestigatorAlbany Medical College
1 Previous Clinical Trials
50 Total Patients Enrolled
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