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Randomized Trial of Two Analgesics in Elderly ED Patients

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ClinicalTrials.gov Identifier: NCT02703610
Recruitment Status : Not yet recruiting
First Posted : March 9, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Chang, Albany Medical College

Brief Summary:
The purpose of this study is to perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.

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

Detailed Description:

To perform a randomized, double blind 2-arm clinical trial of the comparative efficacy of 2 oral analgesics in the the management of acute pain in elderly patients who present and then are discharged from the ED.. The 2 groups are as follows:

  1. Oxycodone/acetaminophen (5/325)
  2. Ibuprofen/acetaminophen (400/500)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial of Two Analgesics in Elderly ED Patients
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020


Arm Intervention/treatment
Active Comparator: Oxycodone/acetaminophen
Oxycodone/acetaminophen (5 mg/325 mg)
Drug: Oxycodone/acetaminophen
Patients will be discharged home with a 3 day supply of oxycodone/acetaminophen
Other Name: Percocet

Active Comparator: Ibuprofen/acetaminophen
Ibuprofen/acetaminophen (400 mg/500 mg)
Drug: Ibuprofen/acetaminophen
Patients will be discharged home with a 3 day supply of ibuprofen/acetaminophen




Primary Outcome Measures :
  1. Between group difference in change in NRS pain scores [ Time Frame: 24 hours ]
    Between group difference in change in NRS pain scores at 24 hours


Secondary Outcome Measures :
  1. Between group difference in change in NRS pain scores at first followup contact [ Time Frame: 24-72 hours ]
    Between group difference in change in NRS pain scores at first followup contact

  2. Between group difference in change in NRS pain scores [ Time Frame: 48 hours and 72 hours ]
    Between group difference in change in NRS pain scores at 48 hours and 72 hours

  3. Between group difference in side effects [ Time Frame: 24 hours, 48 hours and 72 hours ]
    Proportion with side effects (nausea, vomiting, pruritus, dizziness, drowsiness, constipation)

  4. Change in NRS pre and 2 hours post most recent dose of pain medication taken [ Time Frame: 24 hours ]
    Change in NRS pre and 2 hours post most recent dose of pain medication taken

  5. Between group difference in Likert pain scores [ Time Frame: 24, 48, and 72 hours ]
    Pain evaluation on a 4 point Likert scale (none, mild, moderate, severe)

  6. Satisfaction [ Time Frame: 24, 48, and 72 hours ]
    Satisfaction assessed by 4-point Likert Scale: very satisfied, satisfied, unsatisfied, very unsatisfied

  7. Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain. [ Time Frame: 24-72 hours ]
    Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain.

  8. Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to [ Time Frame: 24-72 hours ]
    Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to

  9. Want same medication again [ Time Frame: 24-72 hours ]
    Between group difference in proportion of patients who would want the same medication again



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complaint of acute pain of < 7 days duration
  • ED attending plans to discharge patient home with an oral analgesic

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
  • Ibuprofen or acetaminophen or opioids taken in past 4 hours
  • 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

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): NCT02703610


Contacts
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Contact: Abigale Eichelman 518-264-6059 eichela@amc.edu

Locations
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United States, New York
Albany Medical College Not yet recruiting
Albany, New York, United States, 12208
Contact: Andrew K Chang, MD, MS    518-262-0042    achang3@yahoo.com   
Principal Investigator: Andrew K Chang, MD, MS         
Sponsors and Collaborators
Albany Medical College

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Responsible Party: Andrew Chang, Professor, Albany Medical College
ClinicalTrials.gov Identifier: NCT02703610     History of Changes
Other Study ID Numbers: 4733
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Andrew Chang, Albany Medical College:
Pain
Elderly

Additional relevant MeSH terms:
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Oxycodone
Acetaminophen
Ibuprofen
Acetaminophen, hydrocodone drug combination
Analgesics
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