Phase 2
N=80
Analgesic Efficacy of (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet)
Pain Management
Bottom Line
View on ClinicalTrials.gov: NCT03088826 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Pain Reduction at 60 Minutes (Baseline Pain Score - Pain Score at 60 Minutes) — 3.95; 3.95 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Morphine Sulfate (Drug); Oxycodone (Drug); Acetaminophen (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Antonios Likourezos
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Reduction at 60 Minutes (Baseline Pain Score - Pain Score at 60 Minutes) |
3.95; 3.95 | — |
Summary
Oxycodone and Hydrocodone are the most commonly used oral opioid analgesics in the emergency department and in outpatient settings. Both medications have a very high potential for abuse due to the prominence of the euphoric effect (abuse liability) and relative lack of "bad "or "negative" effects (likeability). The highly addictive properties of these medications lead to recurrent ED visits for repetitive dosing and prescribing that may lead to abuse, misuse, development of dependence and addiction, and, most importantly, death due to overdose. In contrast, several research papers demonstrated that administration of MSIR results in similar analgesic efficacy to Oxycodone and Hydrocodone but with significantly less euphoric and rewarding associated effects. In addition, consumption of large doses of MSIR leads to dysphoria, vomiting and sedation ("negative effects"). To the investigators' knowledge, there are no randomized controlled trials in the ED that directly compared analgesic efficacy of MSIR to Percocet
Eligibility Criteria
Inclusion Criteria
- ages 18-64,
- present to the Emergency department with moderate-to-severe acute pain that warrants an oral opioid analgesic.
- pain score is above 5 and are deemed to require oral opioid at the discretion of the attending physician.
- Painful conditions will include but will not be limited to acute traumatic/non-traumatic musculoskeletal pain, renal colic pain, dental pain.
Exclusion Criteria
- age 64,
- subjects who received long acting opioids within 24 hours of presenting to ED
- received short acting analgesics within 4 hours,
- chronic pain,
- pregnant patients,
- patient refusal,
- altered mental status,
- known allergy to either morphine or oxycodone or acetaminophen,
- history of substance and opioid abuse,
- unstable vital signs, acute psychosis or incarceration.
- subjects who received long acting opioids within 24 hours of presenting to ED;
- chronic pain"
Data sourced from ClinicalTrials.gov (NCT03088826). 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.