Comparing Five Oral Analgesics for Treatment of Acute Pain in the ED


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Verified May 2017 by Polly Bijur, Albert Einstein College of Medicine, Inc.

Sponsor:

Information provided by (Responsible Party):

Polly Bijur, Albert Einstein College of Medicine, Inc.

ClinicalTrials.gov Identifier:

NCT03173456

First received: May 30, 2017

Last updated: May 30, 2017

Last verified: May 2017

This study compares the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for the treatment of patients with acute musculoskeletal pain who present to the Emergency Department (ED).

Musculoskeletal Pain Drug: oxycodone/APAP
Drug: hydrocodone/APAP
Drug: codeine/APAP
Drug: 400 ibuprofen/APAP
Drug: 800 ibuprofen/APAP
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized controlled trial

Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Masking Description:

A pharmacist working in an area inaccessible to ED staff will ensure blinding of the study by masking the medication and inserting it into indentical unmarked gel capsules, filling any void with small amounts of lactose. Randomization will be performed in blocks of 10 determined by a sequence generated at http://www.randomization.com. The pharmacist will make up numbered research packets based on the random allocation list, each with 5 tablets containing the masked investigational medication. Research packets will be removed sequentially by the nurse from the Pyxis automated medical dispensing system and administered to the study patients in the ED.

Primary Purpose: Treatment

Official Title: Comparing the Efficacy of Five Oral Analgesics for Treatment of Acute Musculoskeletal Extremity Pain in the ED

Primary Outcome Measures:

Secondary Outcome Measures:

  • Change in patients’ rating of pain intensity from time of ingestion of study medication to two hours after ingestion of the study medication. [ Time Frame: Ingestion of study medication to two hours after ingestion of the study medication ]

    Pain intensity measured by 11-point Numerical Rating Scale of Pain

  • Proportion of patients who receive rescue medication [ Time Frame: Entire two-hour time period ]

    Record of additional analgesics

  • Proportion of patients who would choose to take the study medication again if they returned to the ED with similar pain [ Time Frame: End of two-hour time period ]

    Question asked at end of two-hour time period

  • Proportion of patients who experience side effects one hour after ingestion of study medication [ Time Frame: From time of ingestion of study medication to one hour later ]

    Question asked at one hour

  • Proportion of patients who experience side effects in two hours after ingestion of study medication [ Time Frame: From time of ingestion of study medication to two hours later ]

    Question asked at two hours

Estimated Enrollment: 550
Anticipated Study Start Date: July 1, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Active Comparator: oxycodone/APAP

5 mg oxycodone + 325 mg acetaminophen

Drug: oxycodone/APAP

Oxycodone/acetaminophen 5 mg-325 mg oral tablet

Active Comparator: hydrocodone/APAP

5 mg hydrocodone + 300 mg acetaminophen

Drug: hydrocodone/APAP

Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet

Active Comparator: codeine/APAP

30 mg codeine + 300 mg acetaminophen

Drug: codeine/APAP

Codeine/acetaminophen 30 mg-300mg oral tablet

Active Comparator: 400 ibuprofen/APAP

400 mg ibuprofen + 1000 mg acetaminophen

Drug: 400 ibuprofen/APAP

ibuprofen/acetaminophen 400 mg-1000mg oral tablet

Active Comparator: 800 ibuprofen/APAP

800 mg ibuprofen + 1000 mg acetaminophen

Drug: 800 ibuprofen/APAP

ibuprofen/acetaminophen 800 mg-1000 mg oral tablet

The optimal treatment of musculoskeletal extremity pain in the ED not known. The study is a randomized controlled trial designed to compare the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for the treatment of patients with acute musculoskeletal pain. The primary outcome is the between treatment group difference in change in patients’ rating of pain intensity one hour after ingestion of the study medication. Secondary outcomes include: 1) the between treatment group difference in change in patients’ rating of pain intensity two hours after ingestion of the study medication; 2) difference in proportion of patients who receive rescue medication; 3) difference in proportion of patients who would choose to take the study medication again if they returned to the ED with similar pain; 4) difference in proportion of patients who experience side effects.

Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients ages 21 through 64 years of age
  • Complaint of acute musculoskeletal pain in one or more extremity, defined as distal to and including the shoulder or hip joints.
  • Pain of less than seven days duration
  • Patient speaks Spanish or English
  • The clinician plans to treat the patient in the ED with oral analgesics and is willing to treat the patient with opioid analgesics or up to 800 mg ibuprofen and 1000 mg acetaminophen
  • Patient is going to receive imaging of the painful extremity
  • Clinician judges patient to have capacity to provide informed consent

Exclusion Criteria:

  • Patient does not have cell phone or cannot receive a verification phone call on their cell phone while in the ED
  • Any use of methadone currently or previously
  • Chronic condition requiring frequent pain management such as arthritis, 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 24 hours
  • Any other prescribed or over the counter topical or oral analgesics taken in past 24 hrs
  • Pregnancy by either urine or serum HCG testing
  • Breastfeeding per patient report
  • History of peptic ulcer disease
  • 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
  • Lacerations,
  • Multiple injuries
  • 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03173456

Montefiore Medical Center
The Bronx, New York, United States, 10467
Contact: David Esses, MD    718-920-2084    desses@montefiore.org   

Albert Einstein College of Medicine, Inc.

Principal Investigator: Polly Bijur, PhD Albert Einstein College of Medicine, Inc.

Responsible Party: Polly Bijur, Professor of Emergency Medicine, Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier: NCT03173456     History of Changes
Other Study ID Numbers: 2016-7322
Study First Received: May 30, 2017
Last Updated: May 30, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Polly Bijur, Albert Einstein College of Medicine, Inc.:

acute pain
musculoskeletal pain
emergency medicine
Emergency Service, Hospital
analgesics
Acetaminophen
Ibuprofen
oxycodone
hydrocodone
codeine
adult

Additional relevant MeSH terms:

Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Ibuprofen
Codeine
Hydrocodone
Analgesics
Oxycodone
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

ClinicalTrials.gov processed this record on June 01, 2017