Status:
COMPLETED
Analgesic Efficacy of Orally Administered VTS-K for Pain Management
Lead Sponsor:
Antonios Likourezos
Conditions:
Pain, Acute
Eligibility:
All Genders
18-110 years
Brief Summary
A combination of ketamine and aspirin for the treatment of acute MSK pain in the ED would confer multimodal analgesia, with the contributions of aspirin and ketamine to an opioid sparing effect. Resea...
Detailed Description
STUDY OBJECTIVES To evaluate analgesic efficacy of orally administered VTS-K (liquid oral ketamine taken simultaneously with VTS-Aspirin and oral ketamine (in a liquid form)) for pain management of a...
Eligibility Criteria
Inclusion
- 18 years+
- presenting to Maimonides Medical Center ED
- acute musculoskeletal painful conditions (traumatic and non-traumatic) with an initial pain score of 5 on a standard 11- point (0 to 10) numeric rating scale
- be awake, alert, and oriented to person, place, and time,
- demonstrate understanding of the informed consent process and content.
- have to demonstrate ability to verbalize the nature of any adverse effects they might experience as well as to express their pain severity by using the NRS.
Exclusion
- Patients with altered mental status
- allergy to aspirin and ketamine
- pregnant patients
- unstable vital signs (systolic blood pressure \<90 or\>180 mm Hg
- pulse rate \<50 or \>150 beats/min
- 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 :
January 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04702555
Start Date
January 8 2021
End Date
December 31 2021
Last Update
April 8 2022
Active Locations (1)
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1
Maimonides Medical Center
Brooklyn, New York, United States, 11219