Status:
COMPLETED
An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache
Lead Sponsor:
Antonios Likourezos
Conditions:
Pain
Eligibility:
All Genders
18-120 years
Phase:
PHASE4
Brief Summary
Headaches affect over 50% of patients annually, with close to 4% of ED visits for headache. Most headaches managed in the ED are benign, with 90% of these headaches classified as tension, migraine, or...
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 Nurtec ODT (Rimegepant) for pain managemen...
Eligibility Criteria
Inclusion
- Patients age 18 and older
- Acute Headache
- 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, ketamine and rimegepant,
- pregnancy and breastfeeding
- 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 or acetaminophen within 4 hours of arrival
- active PUD
- history of GI Hemorrhage
- history of renal and hepatic insufficiency
- past medical history of alcohol or drug abuse
- schizophrenia
- clinical findings concerning for acute intracranial process, acute infections process
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04860713
Start Date
April 22 2021
End Date
November 17 2022
Last Update
January 31 2024
Active Locations (1)
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1
Maimonides Medical Center
Brooklyn, New York, United States, 11219