Randomized Trial of Two Analgesics in Elderly ED Patients

NCT02703610 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 4733
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain; Elderly

Outcome Measures

Primary Outcomes (1)

• Between group difference in change in NRS pain scores

  Between group difference in change in NRS pain scores at 24 hours

  24 hours

Secondary Outcomes (9)

• 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

  48 hours and 72 hours

• Between group difference in side effects

  24 hours, 48 hours and 72 hours

• Change in NRS pre and 2 hours post most recent dose of pain medication taken

  24 hours

• Between group difference in Likert pain scores

  24, 48, and 72 hours

Study Arms (2)

Oxycodone/acetaminophen

ACTIVE COMPARATOR

Oxycodone/acetaminophen (5 mg/325 mg)

Drug: Oxycodone/acetaminophen

Ibuprofen/acetaminophen

ACTIVE COMPARATOR

Ibuprofen/acetaminophen (400 mg/500 mg)

Drug: Ibuprofen/acetaminophen

Interventions

Oxycodone/acetaminophen DRUG

Patients will be discharged home with a 3 day supply of oxycodone/acetaminophen

Also known as: Percocet

Oxycodone/acetaminophen

Ibuprofen/acetaminophen DRUG

Patients will be discharged home with a 3 day supply of ibuprofen/acetaminophen

Ibuprofen/acetaminophen

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical College

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Pain

Interventions

oxycodone-acetaminophen; Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 9, 2016
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)