Randomized Trial of Two Analgesics in Elderly ED Patients

4733

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.

2024-07-01

2026-07-30

2026-07-30

Withdrawn

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-09-21