Status:
COMPLETED
A Comparison of Proprietary Formulations of Oral Ketamine + Aspirin and Oral Ketamine Alone for Musculoskeletal Pain
Lead Sponsor:
Antonios Likourezos
Conditions:
Pain
Eligibility:
All Genders
18-120 years
Phase:
PHASE4
Brief Summary
Acute Pain is one of the most frequent chief complaints and the main reason for visiting the Emergency Department (ED). The acute pain in the ED is largely prevalent across the country with recent lit...
Detailed Description
STUDY OBJECTIVES: To compare analgesic efficacy and rates of side effects of a proprietary formulation of orally administered aspirin and ketamine (AOK) to a proprietary formulation of Oral Ketamine (...
Eligibility Criteria
Inclusion
- Patients age 18 and older
- acute musculoskeletal pain
- initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.
- awake, alert, and oriented to person, place, and time
Exclusion
- altered mental status,
- allergy to aspirin and ketamine,
- pregnant
- unstable vital signs (systolic blood pressure \<90 or\>180 mm Hg, pulse rate \<50 or \>150 beats/ min, and respiration rate \<10 or \>30 breaths/min)
- inability to provide consent
- consumption of Aspirin or NSAID's within 6 hours of arrival to the ED
- active PUD
- history of GI Hemorrhage
- history of renal and hepatic insufficiency
- past medical history of alcohol or drug abuse
- schizophrenia
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04860804
Start Date
April 22 2021
End Date
December 31 2021
Last Update
July 17 2024
Active Locations (1)
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1
Maimonides Medical Center
Brooklyn, New York, United States, 11219