CompletedPhase 4ketamine

An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache

Sponsored by Antonios Likourezos

NCT ID
NCT04860713
Target Enrollment
5 participants
Start Date
2021-04-22
Est. Completion
2022-11-17

About This Study

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 cluster. At present, the satisfaction with ED treatment of headache is low, and despite the multitude of available medications, the evidence- based treatment options are often quite limited. There are over twenty different types of medications available to the ED clinicians for managing headache, many with different routes of administration (parenteral, intranasal, subcutaneous, and oral). Many of these medications are provided in so-called "headache cocktail", which varies based on the physician, institution, and patient preferences.

Conditions Studied

Pain

Interventions

  • aspirin and ketamine
  • Nurtec (Rimegepant)

Eligibility

Age:18 Years - 120 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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

Study Locations (1)

Maimonides Medical Center
Brooklyn, New York, United States

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source