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

• Sponsor: Antonios Likourezos (Other)
• Overall Status: Completed
• CT.gov ID: NCT03088826
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 40.1
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 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: Aug 18, 2017
• Actual Primary Completion Date: Dec 22, 2020
• Actual Study Completion Date: Dec 22, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain Reduction at 60 Minutes (Baseline Pain Score - Pain Score at 60 Minutes) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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"

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maimonides Medical Center	Brooklyn	New York	United States	11219

Sponsors and Collaborators

• Antonios Likourezos

Investigators

• Principal Investigator: Sergey Motov, MD, Maimonides Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 22, 2016

More Information

Publications

None provided.

• Responsible Party: Antonios Likourezos, Co-Investigator, Maimonides Medical Center
• ClinicalTrials.gov Identifier: NCT03088826
• Other Study ID Numbers: 2017-01-05
• First Posted: Mar 23, 2017
• Last Update Posted: Mar 14, 2022
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acetaminophen; Morphine; Oxycodone

Study Results

Participant Flow

Arm/Group Title	MSIR and Acetaminophen Group	Oxycodone and Acetaminophen Group
Arm/Group Description	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	The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen Oxycodone: 10mg Oxycodone Acetaminophen: 650 mg Acetaminophen
Period Title: Overall Study
STARTED	40	40
COMPLETED	40	40
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	MSIR and Acetaminophen Group	Oxycodone and Acetaminophen Group	Total
Arm/Group Description	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	The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen Oxycodone: 10mg Oxycodone Acetaminophen: 650 mg Acetaminophen	Total of all reporting groups
Overall Participants	40	40	80
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.7 (13.2)	46.3 (14.6)	43.5 (14.2)
Sex: Female, Male (Count of Participants)
Female	12 30%	20 50%	32 40%
Male	28 70%	20 50%	48 60%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	40 100%	40 100%	80 100%

Outcome Measures

1. Primary Outcome

Title	Pain Reduction at 60 Minutes (Baseline Pain Score - Pain Score at 60 Minutes)
Description	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.
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MSIR and Acetaminophen Group	Oxycodone and Acetaminophen Group
Arm/Group Description	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	The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen Oxycodone: 10mg Oxycodone Acetaminophen: 650 mg Acetaminophen
Measure Participants	40	40
Mean (Standard Deviation) [units on a scale]	3.95 (2.29)	3.95 (2.37)

Adverse Events

Time Frame	60 minutes
Arm/Group Title	MSIR and Acetaminophen Group		Oxycodone and Acetaminophen Group
Arm/Group Description	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		The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen Oxycodone: 10mg Oxycodone Acetaminophen: 650 mg Acetaminophen
All Cause Mortality
	MSIR and Acetaminophen Group		Oxycodone and Acetaminophen Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Serious Adverse Events
	MSIR and Acetaminophen Group		Oxycodone and Acetaminophen Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	MSIR and Acetaminophen Group		Oxycodone and Acetaminophen Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.