Randomized Trial of Two Analgesics in Elderly ED Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-07-30

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Oxycodone/acetaminophen

Oxycodone/acetaminophen (5 mg/325 mg)

Group Type ACTIVE_COMPARATOR

Oxycodone/acetaminophen

Intervention Type DRUG

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

Ibuprofen/acetaminophen

Ibuprofen/acetaminophen (400 mg/500 mg)

Group Type ACTIVE_COMPARATOR

Ibuprofen/acetaminophen

Intervention Type DRUG

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

Interventions

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Oxycodone/acetaminophen

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

Intervention Type DRUG

Ibuprofen/acetaminophen

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

Intervention Type DRUG

Other Intervention Names

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Percocet

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No