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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
The investigators' hypothesis is that MSIR coupled with acetaminophen will have similar if not better analgesic efficacy at 30 minutes and 1 hour than oxycodone coupled with acetaminophen for acute painful conditions in the emergency department.
This study will be a double-blind randomized clinical trial evaluation analgesic efficacy of orally administered MISIR+acetaminophen in comparison to Oxycodone+acetaminophen for treating pain. Patients will be enrolled from a single ED in a tertiary academic center.
Patients based on inclusion criteria will be randomized to receive either 1 tablet of 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen or 1 tablet 10mg Oxycodone combined with 650 mg Acetaminophen. All drugs will be crushed and given to the subjects in blinded fashion. Patients, physicians, nurses and research assistants will be blinded to drug assignment throughout the study. Medication will be prepared by on site pharmacist.
Pain will be reassessed at both 30 minutes, 45 minutes and 1 hour with the primary outcome of reduction in pain score by 1.3 points at 60 minutes. Assuming a 1.7 pain difference is minimally significant clinically with standard deviation of 3.0 (based on a previous study of morphine analgesia), a minimum of 50 patients per group will be needed for 80% power with alpha equal to 0.05.
Secondary outcomes will include any reported adverse effects; the requirement of additional analgesia.
Generalized likability and chance of repeated use will be reported by using a visual analogue scale with following questions:
"Do you feel any DRUG EFFECT?" "Do you LIKE the drug?" "How HIGH are you?" "Does the drug have any GOOD EFFECTS?" "Does the drug have any BAD EFFECTS?" "How much do you DESIRE the medication?" " Does the drug make you have UNPLEASANT THOUGHTS?" "Does the drug make you have UNPLEASANT BODILY SENSATIONS?" "Does the drug make you feel IRRITATED?" "Does the drug make it DIFFICULT TO CONCENTRATE?"
The patients will respond by positioning an arrow along a 100-point line labeled with "not at all" at one end and "extremely" at the other.
Data will be analyzed by intention to treat and will include frequency distributions, and Student's T-test to assess a difference in pain scores and vital signs. The chi-square test will assess the presence or absence of side effects between the two groups. Statistical analyses will be conducted by the research manager and the hospital senior biostatistician who will be independent of all data collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSIR and Acetaminophen Group | Active Comparator | The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen |
|
| Oxycodone and Acetaminophen Group | Active Comparator | The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine Sulfate | Drug | 15mg PO morphine sulfate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Reduction at 60 Minutes (Baseline Pain Score - Pain Score at 60 Minutes) | The reduction of pain at 60 minutes from baseline: The pain scale ranges from 0 to 10 with 0 being no pain, 5 being moderate pain and 10 being very severe pain. | 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergey Motov, MD | Maimonides Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | MSIR and Acetaminophen Group | The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen Morphine Sulfate: 15mg PO morphine sulfate Acetaminophen: 650 mg Acetaminophen |
| FG001 | Oxycodone and Acetaminophen Group | The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen Oxycodone: 10mg Oxycodone Acetaminophen: 650 mg Acetaminophen |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MSIR and Acetaminophen Group | The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen Morphine Sulfate: 15mg PO morphine sulfate Acetaminophen: 650 mg Acetaminophen |
| BG001 | Oxycodone and Acetaminophen Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Reduction at 60 Minutes (Baseline Pain Score - Pain Score at 60 Minutes) | The reduction of pain at 60 minutes from baseline: The pain scale ranges from 0 to 10 with 0 being no pain, 5 being moderate pain and 10 being very severe pain. | Posted | Mean | Standard Deviation | units on a scale | 60 minutes |
|
60 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MSIR and Acetaminophen Group | The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen Morphine Sulfate: 15mg PO morphine sulfate Acetaminophen: 650 mg Acetaminophen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sergey Motov | Maimonides Medical Center | 718283600 | smotov@maimonidesmed.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2016 | Jan 27, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D010098 | Oxycodone |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Oxycodone |
| Drug |
10mg Oxycodone |
|
| Acetaminophen | Drug | 650 mg Acetaminophen |
|
The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen Oxycodone: 10mg Oxycodone Acetaminophen: 650 mg Acetaminophen |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Oxycodone and Acetaminophen Group | The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen Oxycodone: 10mg Oxycodone Acetaminophen: 650 mg Acetaminophen | 0 | 40 | 0 | 40 | 0 | 40 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003061 | Codeine |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |