Randomized Trial of Two Analgesics in Elderly ED Patients

Albany Medical College

Status and phase: Withdrawn; Phase 4

Conditions: Pain

Treatments: Drug: Ibuprofen/acetaminophen; Drug: Oxycodone/acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT02703610

4733

Details and patient eligibility

About

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.

Full 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)

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Oxycodone/acetaminophen

Active Comparator group

Description:

Oxycodone/acetaminophen (5 mg/325 mg)

Treatment:

Drug: Oxycodone/acetaminophen

Ibuprofen/acetaminophen

Active Comparator group

Description:

Ibuprofen/acetaminophen (400 mg/500 mg)

Treatment:

Drug: Ibuprofen/acetaminophen