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Comparative Efficacy of 4 Oral Analgesics

This study is currently recruiting participants.
Verified September 2016 by Montefiore Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02455518
First Posted: May 28, 2015
Last Update Posted: September 19, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Montefiore Medical Center
  Purpose
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 Intervention Phase
Pain Drug: Oxycodone/acetaminophen Drug: Hydrocodone/acetaminophen Drug: Codeine/acetaminophen Drug: Ibuprofen/acetaminophen Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group 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

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Between group difference in change in NRS pain scores [ Time Frame: 1 hour ]
    Change in NRS pre and 1 hour post receiving study medication while in the ED


Secondary Outcome Measures:
  • Between group difference in change in NRS pain scores [ Time Frame: 2 hours ]
    Change in NRS pre and 2 hours post receiving study medication while in the ED


Estimated Enrollment: 400
Study Start Date: July 2015
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (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
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


Contacts
Contact: Andrew Chang, MD 718-920-2606 achang3@yahoo.com

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Andrew Chang, MD    718-920-6626    achang3@yahoo.com   
Sponsors and Collaborators
Montefiore Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02455518     History of Changes
Other Study ID Numbers: 2014-4156
First Submitted: May 22, 2015
First Posted: May 28, 2015
Last Update Posted: September 19, 2016
Last Verified: September 2016

Keywords provided by Montefiore Medical Center:
pain

Additional relevant MeSH terms:
Acetaminophen
Ibuprofen
Acetaminophen, hydrocodone drug combination
Analgesics
Oxycodone
Hydrocodone
Codeine
Analgesics, Non-Narcotic
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