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Comparative Efficacy of 4 Oral Analgesics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02455518
Recruitment Status : Completed
First Posted : May 28, 2015
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Chang, MD, Montefiore Medical Center

Study Description
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Brief Summary:
The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED.

Condition or disease Intervention/treatment Phase
Pain Drug: Oxycodone/acetaminophen Drug: Hydrocodone/acetaminophen Drug: Codeine/acetaminophen Drug: Ibuprofen/acetaminophen Phase 4

Detailed Description:

To perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED. The 4 groups are as follows:

  1. Oxycodone/acetaminophen (5/325)
  2. Hydrocodone/acetaminophen (5/325)
  3. Codeine/acetaminophen (30/300)
  4. Ibuprofen/acetaminophen (400/1000)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Efficacy of 4 Oral Analgesics for the Initial Management of Acute Musculoskeletal Extremity Pain
Study Start Date : July 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 4, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Oxycodone/acetaminophen
Oxycodone/acetaminophen (5 mg/325 mg)
 Drug: Oxycodone/acetaminophen
Other Name: Percocet
Active Comparator: Hydrocodone/acetaminophen
Hydrocodone/acetaminophen (5 mg/300 mg)
 Drug: Hydrocodone/acetaminophen
Other Name: Norco
Active Comparator: Codeine/acetaminophen
Codeine/acetaminophen (30 mg/300 mg)
 Drug: Codeine/acetaminophen
Other Name: Tylenol with codeine
Active Comparator: Ibuprofen/acetaminophen
Ibuprofen/acetaminophen (400 mg/1000 mg)
 Drug: Ibuprofen/acetaminophen


Outcome Measures
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Primary Outcome Measures :
  1. Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores [ Time Frame: 2 hours ]
    Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)


Secondary Outcome Measures :
  1. Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores [ Time Frame: 1 hour ]
    Change in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complaint of acute pain of < 7 days duration
  • Location of pain in one or more extremities defined as distal to and including the shoulder joint in the upper extremities and distal to and including the hip joint in the lower extremities;
  • Radiologic evaluation is planned

Exclusion Criteria:

  • Inability to confirm reliable means of phone followup.
  • Past use of methadone
  • Chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy
  • History of an adverse reaction to any of the study medications
  • Opioids taken in the past 24 hours
  • Ibuprofen or acetaminophen taken in past 8 hours
  • Pregnancy by either urine or serum HCG testing
  • Breastfeeding per patient report
  • History of peptic ulcer disease
  • Report of any prior use of recreational narcotics
  • Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's or Cushing's disease
  • Taking any medicine that might interact with one of the study medications, such as antidepressant SSRI's or Tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, Amiodarone or Dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine, or St John's Wort.
Contacts and Locations
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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): NCT02455518


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
  Study Documents (Full-Text)

Documents provided by Andrew Chang, MD, Montefiore Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] May 27, 2015
Informed Consent Form  [PDF] May 27, 2015

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Andrew Chang, MD, PI, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02455518    
Other Study ID Numbers: 2014-4156
First Posted: May 28, 2015    Key Record Dates
Results First Posted: February 13, 2018
Last Update Posted: February 13, 2018
Last Verified: February 2018
Keywords provided by Andrew Chang, MD, Montefiore Medical Center:
pain
Additional relevant MeSH terms:
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Acetaminophen
Ibuprofen
Acetaminophen, hydrocodone drug combination
Oxycodone
Hydrocodone
Codeine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
 Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents