Phase 4
Completed N=60
A Comparison of Proprietary Formulations of Oral Ketamine + Aspirin and Oral Ketamine Alone for Musculoskeletal Pain
Source: ClinicalTrials.gov NCT04860804 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Change in Pain Score at 60 Minutes — 2.18; 4.01 units on a scale
◆ Published Evidence
Emerging
2citations · ~1 / year
Oral Aspirin/ketamine versus oral ketamine for emergency department patients with acute musculoskeletal pain.
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.
Linked Publications
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Oral Aspirin/ketamine versus oral ketamine for emergency department patients with acute musculoskeletal pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Score at 60 Minutes |
2.18; 4.01 | — |
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
Data sourced from ClinicalTrials.gov (NCT04860804) and the linked publication. 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.