Randomized Trial of Two Analgesics in Elderly ED Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Pain
• Intervention / Treatment: Drug: Oxycodone/acetaminophen; Drug: Ibuprofen/acetaminophen

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)

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Abigale Eichelman; Phone Number: 518-264-6059; Email: eichela@amc.edu

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
      • Contact: Andrew K Chang, MD, MS; Phone Number: 518-262-0042; Email: achang3@yahoo.com
      • Principal Investigator: Andrew K Chang, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between group difference in change in NRS pain scores	Between group difference in change in NRS pain scores at 24 hours	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between group difference in change in NRS pain scores at first followup contact	Between group difference in change in NRS pain scores at first followup contact	24-72 hours
Between group difference in change in NRS pain scores	Between group difference in change in NRS pain scores at 48 hours and 72 hours	48 hours and 72 hours
Between group difference in side effects	Proportion with side effects (nausea, vomiting, pruritus, dizziness, drowsiness, constipation)	24 hours, 48 hours and 72 hours
Change in NRS pre and 2 hours post most recent dose of pain medication taken	Change in NRS pre and 2 hours post most recent dose of pain medication taken	24 hours
Between group difference in Likert pain scores	Pain evaluation on a 4 point Likert scale (none, mild, moderate, severe)	24, 48, and 72 hours
Satisfaction	Satisfaction assessed by 4-point Likert Scale: very satisfied, satisfied, unsatisfied, very unsatisfied	24, 48, and 72 hours
Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain.	Between group differences in NRS pain scores in patients who have extremity injuries, extremity fractures, and 10/10 pain.	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	Difference in percentage of physicians and patients in each group who successfully identified which study group the patient had been randomized to	24-72 hours
Want same medication again	Between group difference in proportion of patients who would want the same medication again	24-72 hours

Collaborators and Investigators

• Sponsor: Albany Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimated): March 9, 2016

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; Pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Ibuprofen; Oxycodone; Acetaminophen, hydrocodone drug combination
• Other Study ID Numbers: 4733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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