Acetaminophen (APAP) +/- Oxycodone

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

393 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2022-07-31

Brief Summary

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This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen

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Detailed Description

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Conditions

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Musculoskeletal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Acetaminophen

Acetaminophen alone

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Acetaminophen 650mg

Oxycodone/ acetaminophen

Oxycodone + acetaminophen

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Acetaminophen 650mg

Oxycodone

Intervention Type DRUG

Oxycodone 10mg

Interventions

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Acetaminophen

Acetaminophen 650mg

Intervention Type DRUG

Oxycodone

Oxycodone 10mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
* Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity

Exclusion Criteria

* Use of an non-steroidal anti-inflammatory drug within the previous six hours
* Use of acetaminophen within the previous six hours
* Use of an opioid within the previous ten days
* Chronic pain, defined as any pain on \>50% of days for at least 3 months prior to onset of acute pain
* Gout

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No