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Phase 4 N=60 Randomized Treatment

A Comparison of Proprietary Formulations of Oral Ketamine + Aspirin and Oral Ketamine Alone for Musculoskeletal Pain

Pain

Bottom Line

View on ClinicalTrials.gov: NCT04860804 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Change in Pain Score at 60 Minutes — 2.18; 4.01 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Aspirin and Ketamine (Drug); Oral Ketamine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Antonios Likourezos
Primary completion
Nov 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Pain Score at 60 Minutes		 2.18; 4.01 —

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 literature demonstrating that 61-91% of patients are admitted to the ED due to a variety of acute painful syndromes. There is a lack of good options for pain control in such settings.

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • altered mental status,
  • allergy to aspirin and ketamine,
  • pregnant
  • 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
  • active PUD
  • history of GI Hemorrhage
  • history of renal and hepatic insufficiency
  • past medical history of alcohol or drug abuse
  • schizophrenia
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04860804). 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.

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