Phase 4
Completed N=5
An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache
Source: ClinicalTrials.gov NCT04860713 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Change in Pain Score at 60 Minutes — 4; 5 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Score at 60 Minutes |
4; 5 | — |
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 180 mm Hg, pulse rate 150 beats/ min, and respiration rate 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
Data sourced from ClinicalTrials.gov (NCT04860713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.