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Trial record 73 of 665 for:    OXYCODONE

Analgesic Efficacy of (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet)

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ClinicalTrials.gov Identifier: NCT03088826
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Brief 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

Condition or disease Intervention/treatment Phase
Pain Management Drug: Morphine Sulfate Drug: Oxycodone Drug: Acetaminophen Phase 2

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Analgesic Efficacy of Morphine Sulfate Immediate Release (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet) for Acute Pain in Emergency Department Patients
Actual Study Start Date : August 18, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MSIR and Acetaminophen Group
The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen
Drug: Morphine Sulfate
15mg PO morphine sulfate

Drug: Acetaminophen
650 mg Acetaminophen

Active Comparator: Oxycodone and Acetaminophen Group
The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen
Drug: Oxycodone
10mg Oxycodone

Drug: Acetaminophen
650 mg Acetaminophen




Primary Outcome Measures :
  1. Pain Reduction at 60 minutes [ Time Frame: 60 minutes ]
    The reduction of pain at 60 minutes from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <18, 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"

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088826


Contacts
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Contact: Antonios Likourezos, MA, MPH 718-283-6896 alikourezos@maimonidesmed.org
Contact: Christian Fromm, MD 718-283-6391 cfromm@maimonidesmed.org

Locations
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United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Antonios Likourezos, MA, MPH    718-283-6896    alikourezos@maimonidesmed.org   
Contact: Christian Fromm, MD    718-283-6391    cfromm@maimonidesmed.org   
Principal Investigator: Sergey Motov, MD         
Sponsors and Collaborators
Antonios Likourezos
Investigators
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Principal Investigator: Sergey Motov, MD Maimonides Medical Center

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Responsible Party: Antonios Likourezos, Co-Investigator, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT03088826     History of Changes
Other Study ID Numbers: 2017-01-05
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Oxycodone
Acetaminophen
Acetaminophen, hydrocodone drug combination
Morphine
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents